GUIDELINE. 1 August 2014 GUIDELINES FOR THE MANAGEMENT OF TUNNELLED EXTERNALISED SPINAL CATHETERS IN PALLIATIVE CARE PATIENTS

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1 GUIDELINE In the case of hard copies of this policy the content can only be assured to be accurate on the date of issue marked on the document. The Policy framework requires that the policy is fully reviewed on the date shown, but it is also possible that significant changes may have occurred in the meantime. The most up to date policy will always be available on the Intranet Policy web site and staff are reminded that assurance that the most up to date policy is being used can only achieved by reference to the Policy web site. 1 August 2014 GUIDELINES FOR THE MANAGEMENT OF TUNNELLED EXTERNALISED SPINAL CATHETERS IN PALLIATIVE CARE PATIENTS Keywords: intrathecal, spinal catheters, palliative care This document may be made available to the public and persons outside of the Trust as part of the Trust's compliance with the Freedom of Information Act 2000 (Arial 9pt) Date of Issue Review Date (Arial 11pt) POLICY TEMPLATE VERSION/DRAFT NO 1 PAGE 1 OF 34

2 GUIDELINES FOR THE MANAGEMENT OF TUNNELLED EXTERNALISED SPINAL CATHETERS IN PALLIATIVE CARE PATIENTS 1. INTRODUCTION 2. DEFINITIONS 3. PURPOSE 4. ROLES AND RESPONSIBILITIES 5. INTRATHECAL LINE INSERTION TECHNIQUE 6. NURSING MANAGEMENT OF INTRATHECAL LINES 6. TROUBLESHOOTING MANGAEMENT OF COMMON PROBLEMS 7. REMOVAL OF CATHETER 8. PROCEDURES FOR CHANGING INFUSION BAGS, CASSETTES AND PUMP PROGRAMMING 9. PROCEDURE FOR DRESSING CHANGE 10. PROCEDURE FOR FILTER CHANGE APPENDICES Appendix 1 Adult Intrathecal Continuous and PCA Prescription Chart Appendix 2 Pre-programmed PCA Device Alarm and Troubleshooting Cards Appendix 3 Competency for the Care of Patients receiving Intrathecal Analgesia via AmbIt PCA pump POLICY TEMPLATE VERSION/DRAFT NO 1 PAGE 2 OF 34

3 1 INTRODUCTION Spinal administration of drugs can be used in patients, normally with cancer, for whom treatment of pain with oral drugs has been unsuccessful due to either failure of the pain to respond, despite escalating doses of opioids, and/or dose limiting side effects. This method of administration requires care with its use and is not without potential adverse side effects, but has the advantage that it allows the administration of opioids to the pain pathways in the spine, and also the use of other drugs such as local anaesthetics and Clonidine which may be effective for pain which does not respond to opioids alone. The two potential routes of administration are epidural and intrathecal. The intrathecal route is the preferred choice as the doses of drugs required are considerably less, and because epidural catheters frequently become less effective after several weeks, probably due to fibrosis. Also the lower doses of drugs used with intrathecal administration allows for longer intervals between infusion changes reducing potential risk of infection. Patients with these lines in situ can either be managed in the acute hospital setting, hospices or in the community. The pumps that are used with these lines (AmbIT pump) have the option of a continuous infusion +/- a patient controlled bolus dose facility. The bolus facility is normally used in conjunction with the continuous infusion to allow the patient to independently titrate the doses required to control their breakthrough pain. 2 PURPOSE The purpose of these guidelines is to give clear guidance to all staff involved in the management of palliative care patients with tunnelled externalised intrathecal catheters in order to ensure adequate pain relief whilst maintaining patient safety. They also give clear guidance to staff who may be unfamiliar with these devices in order to safely manage these patients. 3. ROLES AND RESPONSIBILITIES 3.1 The Intrathecal catheter is inserted using an aseptic technique by Consultants in Anaesthesia and Pain Medicine in conjunction with the Palliative Care Team. The patient remains under the care of the Palliative Care Consultant who will liaise with the Pain Management Team for advice regarding management of the line and titration of drugs, or side effects. The Pain Management Consultant will prescribe the drug(s), dosage of drugs, the continuous infusion rate, bolus dose rate and patient bolus lockout time on the dedicated Adult Intrathecal Prescription Chart (see Appendix 1). 3.2 The Chronic Pain Nurse Practitioner will provide training and education for all levels of staff in the management of the intrathecal lines, including the training of hospice staff or community staff dependant on where the patient wishes to be nursed. This role also includes domiciliary visits with district nursing teams until community nursing staff have completed training, and are happy to accept responsibility for the management of the line. POLICY TEMPLATE VERSION/DRAFT NO 1 PAGE 3 OF 34

4 N.B. This domiciliary role may, on occasions, involve the Chronic Pain Nurse Practitioners undertaking the administration of drugs for infusion outside of Trust property e.g. at Sue Ryder Hospice or in the patients home, if there is no suitably trained or competent nurse available. It is the responsibility of all staff involved in the care of these patients to ensure that they have sourced the appropriate training and have the knowledge and skills in order to effectively manage and plan their care. 3.3 Staff altering the pump programme or changing infusion bags/cassettes should have received training in these procedures and hold the relevant competency (see appendix 3) 3.4 The contact details for Palliative Care Team, Pain Management Team (including out of hour advice) are as follows: Palliative Care Team Chronic Pain Management Team During office hours: Consultants (during office hours: ) Out of Hours: Via switchboard (03004 Nurse Practitioner: or bleep ) Out of Hours: 1 st on call anaesthetist via bleep 1777 This information can also be found on the back of the Intrathecal Prescription Chart (Appendix 1). 4. INTRATHECAL LINE INSERTION TECHNIQUE 4.1 Before insertion: All staff should have Ensured patient and family understand the procedure and its implications/potential complications and that he/she has given informed consent. Agreed on the best site for catheter anchorage. This is usually on the anterior lower rib cage or, after tunnelling up over the shoulder, on the pectoral area. 4.2 Before the placement of intrathecal line: The initial drug(s) and dose regimen will be prescribed by the Pain Consultant or deputy. Prepare the patient fully for the procedure. Ensure that staff have already explained the procedure and possible adverse effects. Before the procedure ask the patient to empty their bladder. Record baseline observations, BP, pulse, temperature, motor and sensory function. The catheter is inserted in the Operating Theatre under full aseptic conditions and tunnelled under the skin. The preferred route of insertion is intrathecally. A prophylactic dose of intravenous POLICY TEMPLATE VERSION/DRAFT NO 1 PAGE 4 OF 34

5 antibiotic is normally used. A dedicated intrathecal pump called AmbITpump will be used and will be organised by the Pain Management team. The intravenous cannula placed at the time of insertion of the catheter should be maintained for at least 24 hours after the procedure in case of any side-effects. 4.3 The commonest drug combination used is Levo-bupivacaine (trade name Chirocaine), a longacting local anaesthetic, combined with Diamorphine in a dose for intrathecal administration approximately equivalent to 1% of the previous daily oral morphine, and 10% for epidural administration. Other drugs, such as Clonidine, may sometimes be added. Patients can become sedated on their previous dose of oral opioid after spinal analgesia is commenced, so the oral dose is reduced progressively after catheter insertion. In patients who are accustomed to large doses of oral opioids ( non opioid-naïve ) respiratory depression due to spinal opioids is exceedingly rare. At the doses of Bupivacaine used, leg muscle weakness is unusual and responds to reduction of the dose. However, care is needed in the early stages of use of a spinal catheter in case of this, or impaired proprioception in the legs. Patients should not drive and should be assisted with mobility as needed. Note: sudden or rapid onset weakness or numbness in the legs may very rarely be due to spinal cord compression, not to local anaesthetic. It is essential that this is considered: guidance on this can be found in section The normal catheter route and fixation method are as shown: Puncture Sites Entry site: sutured Catheter tunnelled over shoulder......or onto chest wall POLICY TEMPLATE VERSION/DRAFT NO 1 PAGE 5 OF 34

6 4.5 The exit site and bacterial filter are attached as shown below: 5. NURSING MANAGEMENT OF INTRATHECAL LINES Whilst an inpatient (Acute Trust or Hospice) further guidance for the general management and nursing observations are also included on the reverse of the Intrathecal Prescription Chart (see Appendix 1) 5.1 Nursing Observations Observations of blood pressure, pulse, temperature, respiratory rate, pain score, sedation score, sensory level and, motor block monitoring should be performed and these observations documented on the Pain Management Chart and Early Warning Score Chart as follows: After insertion and for first 24 hours: After any change in rate or drug dose: After first 24 hours and for first 7 days Every 30 minutes for 1 hour Then 1 hourly for 2 hours Then 4 hourly for 24 hours 1 hourly for 2 hours 4 hourly for 24 hours Daily temperature, blood pressure, respiratory rate, sensory and motor level block Daily check for urinary retention Regular pain score until stable, then daily or when any changes occur POLICY TEMPLATE VERSION/DRAFT NO 1 PAGE 6 OF 34

7 Insertion site/puncture site Exit site Bacterial filter Observe puncture site/exit site for signs suggestive of infection/leakage report to doctor if signs present Observe for signs suggestive of CSF infection report to doctor if present (see section 5.2) Ensure dressings intact, including security of line between exit and extension 4 hourly check of infusion pump Check daily for redness/inflammation or tenderness and document score Clean/change dressing as necessary using aseptic technique Sutures on tunnelling puncture sites to be removed on Day 5 Monitor for signs of infection report to doctor if signs present Change dressing weekly using aseptic technique or earlier if indicated (see section 9) NB Exit suture must remain in situ Should not be changed unless instructed to do by doctors 5.2 All patients receiving this method of analgesia are at particular risk of infection due to their underlying condition. Four possible sites of infection are identified as: Intrathecal Epidural Tunnelling puncture sites Exit site (Other systemic infections may migrate directly to the catheter via the bloodstream this is called haematogenous spread) Skin care must include the following sites: Catheter entry site (in back) Subcutaneous tunnelling puncture sites Catheter exit site (on chest or abdomen) The drugs are administered to the patient by the dedicated infusion pump. This uses infusion bags which are filled with the drug mixture as prescribed, a dedicated giving set cassette that includes the pump mechanism, and an integral filter. A supplemental bacterial filter must always be attached to the intrathecal line. Additional instructions on how to make up the infusion bags will be given to the staff looking after the patient (see section 8) The risk of infections is increased by opening and closing the system. To minimise this, a drug concentration that maximises the duration of each bag is used. 5.2 The boost button on the pump should be used sparingly and with caution by the patient: with frequent intrathecal use it may result in leg weakness from the local anaesthetic. If frequent POLICY TEMPLATE VERSION/DRAFT NO 1 PAGE 7 OF 34

8 boosts are being used it is preferable to adjust the rate setting. The patient should be in control of the boost button staff should not press and visitors/relatives must be discouraged from doing so. Patients will be educated on how to use the boost button on the pump by the Pain Consultant/Nurse Practitioner. A record of the total amount of drug infused and the successful and unsuccessful boosts should be documented on the Pain Management Chart under PCA (patient controlled analgesia) observation section at the same frequency of the other observations as above. 5.3 The rate setting can be altered according to the needs of the patient within a range as prescribed on the Intrathecal prescription chart by suitably trained and competent staff. Any programme changes must be documented on the intrathecal prescription chart. In some circumstances the patient or carer may be instructed on how to alter the rate, this will be done under the direction of the Pain Consultant. If any alteration has been made by the patient or carer the nurse should record this at the earliest convenience and monitor the observations as indicated on the reverse of the Intrathecal Prescription chart. These observations should be recorded on the Pain Management Chart and the EWS charts accordingly. 5.4 Skin sites must be observed for signs of infection at least daily. These include tunnel puncture sites as well as the catheter entry and exit sites. Infection may be characterised by any of the following: Swelling, redness, soreness, skin irritation. Pyrexia Discharge Palpable inflammation tracking along the course of the catheter (normally sore to touch). Puncture sites from the subcutaneously tunnelled catheter procedure, including the entry site over the spine, will heal in approximately two weeks, and after that no further dressing is necessary. The sutures in the puncture sites should be removed about six days after catheter insertion. Exit site The gauze under the filter(s) is for comfort and to protect the skin. The semi-permeable adhesive dressing secures the filter, protects the area from outside trauma and infection, and reduces movement of the catheter at the exit site. The sutures at the catheter exit site should never be removed: they hold the catheter in. If they become dislodged inform the Pain Consultant immediately. 5.5 Epidural or intrathecal infections are characterised by: Swelling, redness, soreness of the skin and subcutaneous tissue over the spine. Pyrexia Pain on injection Reduction of analgesic effect Non-specific backache Possible headache and neck stiffness POLICY TEMPLATE VERSION/DRAFT NO 1 PAGE 8 OF 34

9 Raised white cell count In intrathecal space infections: neck pain, neck stiffness, reduced alertness or drowsiness. In epidural infections: decreased epidural analgesia, neurological signs of cord or nerve root compression, pain on injection. 5.6 Temperature should be recorded daily to monitor for early signs of infection. 5.7 Pump rate change If any change has been made to the rate of infusion, then this should be documented and the observations performed according to the Intrathecal Prescription Chart. 5.8 If the patient is being cared for at home, then this daily care could be provided by home carers on days when nursing staff are not in attendance, and if any concerns these should be reported to the community nursing staff. 6. TROUBLESHOOTING MANGAEMENT OF COMMON PROBLEMS The Intrathecal line is inserted to provide pain relief to people who are usually suffering with terminal cancer pain. Minor technical problems with the line or pump are common but easily resolved. Rare more serious problems can occur. Below is a list of problems encountered and simple step by step guides on how to address them. Loss of analgesia or increased pain Infection or concerns of infection Technical problems with the catheter Technical problems with the pump Concerns about numbness and weakness in legs 6.1 Loss of Analgesia or Increased Pain: Step 1. Assess patient Patients may have more than one pain. Is the pain the same one for which the line was inserted? If not take a history and examine and treat accordingly. Step 2. Check the line is in place Has it been pulled out or dislodged? Normally a small suture holds the catheter to the skin very close to the exit point. (This suture is in addition to the thick suture holding the hub of the catheter to the skin). Check that there is not more than a very short length of catheter between the exit point and this suture: this could indicate that the catheter has pulled out/dislodged. However, with the internal suturing of the catheter, this is unlikely. POLICY TEMPLATE VERSION/DRAFT NO 1 PAGE 9 OF 34

10 If in doubt the infusion line can be disconnected and a clean 5 ml syringe can be used to aspirate CSF through the filter. Clear fluid (cerebrospinal fluid) should easily fill the syringe. This must only be undertaken by a Pain Consultant or Anaesthetist and under strict aseptic technique. If it does, then the line is in the right place and can be further tested by giving a bolus. Again this must only be undertaken by a Pain Consultant or Anaesthetist. A small bolus of local anaesthetic 1.5 ml of 0.25% chirocaine or bupivacaine can be injected aseptically into the line and should provide quick onset analgesia. If in doubt, the Pain Consultant or on call anaesthetist can be contacted for advice or help. Step 3. Is the patient receiving enough drug? If this small bolus is successful then the drug mixture needs to be given at a higher rate. To do this, follow the simple programming instructions on the laminated card (see appendix 2) or in the AmbIT pump clinician manual that will be with the patient. As a rule the rate can be increased by approximately 20%. For example, if the basal rate was 2.0 ml/hr try increasing to 2.4 ml/hr. If this is insufficient further increases may be required. The greater the infusion rate the greater the likelihood that numbness or weakness of the legs and urinary difficulties may occur. If this is the case it may be necessary to increase the dose of Diamorphine in the infusion bag, to allow reduction in the infusion rate once more. Do not forget that as an interim measure the bolus button on the pump can be pressed. The patient is free to do this but they sometimes forget. It can however be pressed by attendant nursing or medical staff. The lockout is usually 5 minutes, this means the bolus button can be pressed every 5 minutes until the patient is comfortable (the lockout interval may vary between patients). Step 4. Increasing drug dose in bag Diamorphine should probably be the first drug to increase as it is much less likely to cause weakness and numbness of the legs. Follow instructions for refuelling the infusion bag (page 9) and increase the Diamorphine dose by approximately 20%. The dose of local anaesthetic (chirocaine) can be increased but should only be done so if all other measures haven t worked, and in discussion with the Pain Consultant or anaesthetist. Step 5. IF ALL OF ABOVE FAILS If for whatever reason these suggestions don t work then remember analgesia can be provided by other routes. If need be the infusion can be stopped and an appropriate dose of drug orally or subcutaneously can be given. Remembering that: 1. The equivalent doses of Diamorphine given via the routes are as follows: Intrathecal dose - Diamorphine 1mg Epidural dose - Diamorphine 10mg POLICY TEMPLATE VERSION/DRAFT NO 1 PAGE 10 OF 34

11 Intravenous - Diamorphine 100mg Gloucestershire Hospitals In other words Diamorphine given via the intrathecal route is 100 times more potent then the same dose given systemically. 2. After calculating the equivalent dose to give by the chosen route, remember that the intrathecal dose was given over a period of 24 hours, and adjust the dose appropriately, and according to response. If it is necessary to return to oral or subcutaneous opioids then their relevant dose potencies should be borne in mind. A table comparing commonly used drugs is found below IM/SC (mg) Oral (mg) Diamorphine 5 30/60 Fentanyl 0.1 NA Hydromorphone Methadone Morphine Oxycodone Infection: Infection is a possible complication of indwelling intrathecal lines. Superficial infection is reasonably common but is easy to manage and usually does not interfere with the use of the line. Superficial infection Superficial infection can occur at any of the small incisions or where the catheter leaves the body. The first signs would be reddening and localised swelling and possibly discharge of a serous fluid or even pus. As long as the infection remains localised and does not track back along the catheter towards the spine, a topical Betadine spray can be used and cover the area with a bio-occlusive dressing. Leave the dressing and change according to need. If there is concern, a swab can be taken and sent for microbiology, culture & sensitivities. Oral antibiotics may be required. POLICY TEMPLATE VERSION/DRAFT NO 1 PAGE 11 OF 34

12 Advice about wound dressing or wound management is available via the contact numbers in section 6.4. Serious infection The concern with infection is that it may track back along the line of the catheter into the spine causing meningitis and death. In patients with signs of serious systemic infection such as fever, sweats or rigors, spinal infection and/or meningitis should always be suspected. However other common unrelated infections such as respiratory and urinary infections are perhaps more likely explanations and must be considered. Reduced conscious level, headache, photophobia and neck stiffness are signs that would be more specific indicators of spinal infection. The Pain Consultant or deputy should be informed immediately if this is suspected. Under sterile conditions a sample of CSF should be aspirated proximal to the filter (i.e. on the patient side) at the end of the catheter. The fluid may look cloudy if infected and should be sent for urgent microscopy, culture and antibiotic sensitivities. The line should be removed (see section 7) and if appropriate, antibiotic therapy initiated or changed with microbiology advice. Alternative means of analgesia will need to be initiated (see section 6.1). 6.3 Technical Problems with the Catheter: Whilst these problems are rare they can be associated with loss of analgesia and can present as such. Several things can happen: the line can become displaced, disconnected, break or leak. CSF Leak Sometimes CSF may leak from the hole made in the dura to insert the catheter, and track back towards the skin and cause a small collection of fluid to be palpable around one of the skin incisions or even to leak out of the exit wound. This is not usually harmful, and may respond to a pressure dressing over the site. The Pain Consultant or deputy should be informed. Very occasionally this CSF leak can cause a post dural puncture headache. This tends to occur early after catheter insertion, and often gives a headache between the back of the head and forehead worse of sitting or standing up, partly relieved by lying down. If this happens the Pain Consultant or deputy should be informed. Catheter Displacement The catheter is sutured to the spine so catheter displacement is unlikely, however if the catheter does become dislodged its end may not be in the intrathecal space, and as a result the drugs may not be going into the correct place. This may cause a loss of analgesia. POLICY TEMPLATE VERSION/DRAFT NO 1 PAGE 12 OF 34

13 Try aseptically aspirating CSF from the catheter (see section 6.1). If no CSF can be aspirated from the line it is probably displaced and will need to be removed (see section 7). Once again alternative analgesia needs to be provided until another line can be inserted (see section 6.1). Line Breakage Very occasionally a line will fracture or break and will present as a leak or loss of analgesia. If concerned turn off the pump, provide alternative analgesia and contact pain consultant. Line Disconnection Occasionally the catheter may become disconnected from the filter. If this is witnessed without losing sterility at the end of the catheter, then using a sterile technique the filter may be reconnected and the infusion continued. If the disconnection is not witnessed, but found at a later time, then the catheter end will no longer be sterile. In this situation there is high risk is of introducing infection, therefore either: Contact the pain management service for advice via the contact details (see section 3.4). If out-of-hours, then using a sterile technique, clean the disconnected end of the catheter, reattach the filter and close with a sterile bung. Do not use the infusion, but provide analgesia via alternative means (see section 6.1). Then contact the pain management service in the morning for further advice. In occasional circumstances, such as last few days of life, it may be more appropriate to continue to run the intrathecal infusion despite the risk of infection, but the decision to do this would be determined on an individual basis following discussion with Pain Consultant and Palliative Care Team. 6.4 Technical problems with the Pump Laminated cards will be left in the nursing kardex/medical notes for instructions/information about pump alarms & signals and detailed steps on how to programme the pump (see Appendix 2) Please refer to Clinician Manual for further information regarding pump alarms, and programming steps. If there are problems with the pump that cannot be resolved using these instructions then use the spare pump supplied, ensuring that the programme is the same (switch off pump, remove cassette from top of pump by pushing in sides and fit to new pump cassette will only attach one way). If there are problems with the spare pump that cannot be remedied by the use of this guideline use the contact numbers in section 3.4 for advice, or if out-of-hours switch off the pump and use an alternative method of providing pain relief (see section 5) until advice can be sought in the morning. The batteries should be routinely changed in the pump every fortnight unless the pump indicates earlier change required (see clinician manual for instructions on how to change batteries) POLICY TEMPLATE VERSION/DRAFT NO 1 PAGE 13 OF 34

14 6.5 Numbness or Weakness in arms or legs: The usual starting concentration of local anaesthetic used in the infusion is unlikely to cause much in the way of leg numbness or weakness, although higher concentrations may do so. Increasing or new onset of numbness or weakness in the legs, or indeed the arms, may be a sign of spinal cord compression. This may be as a result of: Epidural haematoma Epidural abscess Intraspinal tumour spread or vertebral collapse from tumour Intervertebral disc prolapse Spinal metastases SPINAL CORD COMPRESSION IS AN EMERGENCY AND MUST BE DEALT WITH IMMEDIATELY. NEVER ASSUME THAT SUDDEN OR SEVERE NUMBNESS OR WEAKNESS IS DUE TO THE LOCAL ANAESTHETIC. In order to minimise permanent neurological damage, it requires treatment and/or decompression within hours of onset. The actions required, is something that will be dependent on the individual patient, and the stage of their illness. In the first instance, the pump should be turned off to see if the numbness or weakness improves. If it is due to the local anaesthetic this should begin to happen within 1-2 hours. During this time it may be necessary to provide additional analgesia via alternative means (see section 5) if the pain returns. If the numbness or weakness improves then it is more likely to be due to the local anaesthetic in the infusion, and the infusion could be continued (a bolus may be required initially if the pump has been turned off). If there is no improvement in the numbness or weakness then spinal cord compression should be considered and the Pain Consultant or deputy, or Oncologist or Palliative Care Physician, should be informed immediately, and if necessary an urgent MRI/CT scan arranged. This should be discussed between the attending physician and the Pain Consultant as the intrathecal line is not compatable with MRI scanners, so removal of the line or CT scanning may need to be considered. 7. REMOVAL OF CATHETER These catheters are normally inserted for the management of severe terminal cancer pain. Therefore the catheter usually stays in place until the patient dies. After death there is no need to routinely remove the catheter. The infusion giving set can be disconnected and the filter capped off with a Luer lock bung. With the Codman wire-reinforced catheters a knot in the catheter is sutured to the intervertebral ligament at the spinal entry site, and so it should not be possible to remove the catheter by pulling it. If it is necessary to remover a catheter after death please contact one of the Pain Management team for advice. POLICY TEMPLATE VERSION/DRAFT NO 1 PAGE 14 OF 34

15 Very occasionally lines have to be removed from living patients due to complications such as line sepsis, breakage and leaking. Removal of a line is a sterile technique and should be done by or with the involvement of the Pain Consultant. 8. GUIDELINES FOR CHANGING INFUSION BAGS, CASSETTES AND PUMP PROGRAMMING 8.1 AmbIT operating instructions: The AmbIT pump is a small compact cylindrical pump with two operating buttons and a small LCD screen at the top. It is powered by two size AA batteries in the base of the pump. The batteries need to be changed at fortnightly intervals. The infusion bag runs through a specific giving set through the pump mechanism at the top of the pump. A copy of the operating instructions (clinician manual) with always be left with the pump. Laminated instruction cards with the most commonly encountered problems and instructions on how to recognise and deal with visual and audible alarms and instructions on how to change the programmes and infusion rates are also left with the pump. The Pain Management Service undertake extensive training of nursing staff in hospital and the community prior to line insertion and discharge from hospital. Copies of this guideline are available on both Oncology wards and the Anaesthetic department at Cheltenham General Hospital, and a copy will be made available wherever patients with intrathecal catheters are being looked after. 8.2 Infusion bag changes with the AmbIT pump: Ideally the infusion bags will be prepared in a sterile facility such as the pharmacy manufacturing department, where this is not possible the infusion bags can be prepared in the clinical setting using a strict aseptic technique. Using the strictest sterile technique cannot be over-emphasised as intraspinal infection can be catastrophic for the patient. The AmbIT pump has a dedicated giving set and infusion bags. Each change of infusion bag must be accompanied by a change in the giving set. If the drug dosage in the infusion bag is to be altered, then a new infusion bag must be made up containing the new drug concentrations and a new giving set used. The frequency of changes will depend on the infusion rate, but unnecessary opening of the line should be minimised as this increases the risk of infection. The infusion mixture must be prepared using aseptic precautions, according to the prescription, and the infusion bag labelled appropriately. A clear expiry date must be written on the drug label infusion bags should be changed ideally every 96 hours but may run to a maximum of 7 days, depending on rate of POLICY TEMPLATE VERSION/DRAFT NO 1 PAGE 15 OF 34

16 infusion and size of bag. A risk assessment must be undertaken on each individual patient basis to determine the risk of opening the line versus the risk of continued infusion. Procedure for adding drugs to infusion bags, and changing infusion cassettes on the AmbIT pumps Equipment required: Sterile dressing pack/gloves Apron Prescribed amount of Diamorphine and/or any other drug prescribed Pre-filled bag of local anaesthetic as prescribed 5 or 10ml syringes Green needles Red drawing up needles (with filter) AmBit pump infusion cassette Label Procedure 1. Wash hands according to Trust Policy (link to Hand Hygiene Policy) 2. With another qualified member of staff check intrathecal prescription chart, and drugs, according to hospital policy (link to POPAM) 3. Open dressing pack and empty all equipment on to it including pre-filled local anaesthetic infusion bag and AmBit cassette 4. Put on sterile gloves. Using green needle and syringe, draw off enough of the local anaesthetic from the prefilled bag to dilute contents of the Diamorphine ampoules (normally 5-10 mls). Rationale To reduce risk of cross infection. To ensure safe and appropriate administration of a Controlled Drug according to hospital policy. To ensure correct drug, amount and concentration is administered to the correct patient according to hospital policy. To reduce the risk of cross infection. The drawn off local anaesthetic will be used as a diluent 5. Change green needle to sterile red drawing up needle and draw up contents of Diamorphine 6. 2 nd qualified member of staff to open Diamorphine ampoule and hold, whilst contents are drawn up 7. Add required dose of Diamorphine to prefilled bag of local anaesthetic 8. If further drugs to be added follow above procedure In order for Diamorphine to be diluted and drawn up aseptically. POLICY TEMPLATE VERSION/DRAFT NO 1 PAGE 16 OF 34

17 9. Invert bag several times to ensure even mix of the solution. 10. Using a yellow additives label, document drugs added to the infusion, sign, time and date. Ensure an expiry date is clearly indicated on the label. Affix label to intrathecal infusion bag. 11.Clamp AmBit infusion cassette while connecting to infusion bag, once connected unclamp and run through set (manually squeeze fluid through) NB ensure infusion bag to be inverted 12. Remove orange protective cover. Press down either side on plate of cap of cassette until clicks and rotate spindle 360 degrees to left 13. Check patients ID bracelet against prescription chart with another member of staff before the infusion is commenced, as per hospital policy. 14. Pause AmbIT pump (press top button once 2 lines appear and bleeps) 15. Clamp line connected to patient 16. Put on sterile gloves, place sterile field around connection to patient and loosen luer lock connection to patient 17. Put new line close to patient, then disconnect from patient and connect new line 18. Remove old line from pump (press sides on top of cassette and lift off) 19. Connect new cassette to pump (will only fit one way) 20. Clear history of pump (press bolus button until HX appears, release, and press again until 0 appears). 21. If no programme changes to be made press run button (top button). If programme needs altering follow instruction in clinician manual (Appendix 3) 22. Unclamp line to patient and check for green light flashing on bolus button 23. Dispose of old infusion cassette according to trust policy. (Link to decontamination policy) To ensure all the Diamorphine has entered the epidural infusion bag and has been mixed evenly. To ensure safe labelling of the infusion. To expel any air from infusion bag To expel any micro-air into air filter before commencing infusion To meet Trust policy. To minimise risk of infection Reduce amount of time that line is disconnected To check for indication that pump is running Ensure safe disposal of clinical waste 9. PROCEDURE FOR DRESSING CHANGE POLICY TEMPLATE VERSION/DRAFT NO 1 PAGE 17 OF 34

18 The dressing should be changed weekly unless there is any indication for more frequent changes e.g loose dressing or any staining of dressing that may be indicative of infection Equipment required: Sterile dressing pack with gauze Chloraprep stick Apron Sterile gloves (if not provided in dressing pack) 2 clear occlusive dressings It is suggested that this procedure be performed by two nurses, to minimise the risk of dislodging the catheter whilst changing the dressing Procedure 1.Prepare patient 2.Wash hands according to Trust policy and prepare sterile field (link to Hand hygiene policy) 3.Remove occlusive dressing and gauze pads, ensuring that the catheter is freed from the dressing to avoid pulling on it 4.Observe skin surrounding exit site If any evidence of infection (redness, swelling, discharge) obtain wound swab and send for microbiology, culture and sensitivities If clear discharge noted obtain sample and test for presence of sugar with glucose test strip If either of above evident inform Pain Consultant or Palliative Care Team 5. Clean the exit site if indicated using chloraprep 2% 6 Reapply dressing to exit site sterile gauze to be placed under bacterial filter and connection port to protect skin then apply occlusive dressing Rationale To minimise risk of infection Monitor for signs of localised infection/inflammation To determine of discharge is Cerebro-Spinal Fluid as a result of leakage from the site (if CSF test will be positive) To minimise infection of exit site 10. PROCEDURE FOR FILTER CHANGE The filter attached to the catheter next to the skin is only to be changed on instruction from the Pain Consultant or deputy. This must be done with strict aseptic technique as it is the final barrier against infection entering the spine. Equipment needed: Sterile gloves Apron Dressing pack with gauze swabs & sterile forceps 2 clear occlusive dressings eg Tegaderm or Opsite POLICY TEMPLATE VERSION/DRAFT NO 1 PAGE 18 OF 34

19 Replacement newly prepared infusion bag & infusion cassette containing drug mixture Portex flat Luer lock epidural filter Procedure 1. Prepare patient 2. Wash hands according to Trust policy and prepare sterile field (link to Hand Hygiene policy) 3. Apply sterile gloves and remove occlusive dressing and gauze pads 4.Observe skin surrounding exit site If any evidence of infection (redness, swelling, discharge) obtain wound swab and send for microbiology, culture and sensivities If clear discharge noted obtain sample and test for presence of sugar with glucose test strip If either of above evident inform Pain Consultant or Palliative Care Team 5.Connect new filter to newly prepared infusion bag and infusion cassette (see section 8.2) 6. Remove old filter and & infusion cassette and replace with new set (follow steps as in section 8.2) 7. Reapply dressing (see section 9) 8. Document in medical and nursing notes date and time of filter change Rationale To minimise infection Monitor for signs of localised infection/inflammation To determine of discharge is Cerebro- Spinal Fluid as a result of leakage from the site (if CSF test will be positive) POLICY TEMPLATE VERSION/DRAFT NO 1 PAGE 19 OF 34

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27 Appendix MONITORING COMPLIANCE Annual Audit of compliance with this protocol will be undertaken by the Pain Management Service. Audit of ACI and infections related to this procedure will be undertaken and action plans developed/implemented as necessary. 12. REFERENCES British Pain Society (2008): Intrathecal drug delivery for the management of pain and spasticity in adults; recommendations for best clinical practice Local Spinal Guidelines of the Newcastle Hospices/Hospitals St Oswalds & Marie Curie REVIEW These guidelines will be reviewed in three years time unless clinical practice dictates earlier. POLICY TEMPLATE VERSION/DRAFT NO 1 PAGE 27 OF 34

28 Hospitals Gloucestershire Learning & Development Department Redwood Education Centre Training Needs Analysis for Procedural Documents Handling..Completed on 17 Jan 2009.By Kym Ypres-Smith... *Level of training required B A Staff Group / s Palliative Care Consultants All staff involved in care of patients with intrathecal lines Division / Department Palliative Care Oncology/Anaesthetics Frequency of training / update When required When required Method of training delivery Drop in sessions/workshop Drop in sessions Lead and department responsible for provision of training Sr Jan Joseph/Dr James Decourcy Chronic Pain Management Service POLICY TEMPLATE VERSION/DRAFT NO 1 PAGE 28 OF 34 Pai n Service

29 *Levels of Training A = Awareness (Micro-teach, drop in session, e- learning) B= ½ day (2.5 3 hours) (workshop, training event, e-learning) C = Full day (5-6 hours) (workshop, training event) D= Course (more than one day training) POLICY TEMPLATE VERSION/DRAFT NO 1 PAGE 29 OF 34 Pai n Service

30 Gloucestershire Hospitals TOOL for the Monitoring Compliance of Procedural Documents When developing or updating policies, procedures, protocols or guidelines the author and sponsor must generate and implement a plan for effective Monitoring compliance of the objectives of the individual document. This TOOL is an aid to identify the stage/s* of monitoring compliance required; the objectives to be measured and it must ide ntify who is the responsible lead for ensuring that the report and/or action plan are completed within the agreed timescales. All audit must be orchestrated in conjunction with the Audit Department, who can best advised on methodology and provide support. *There are 5 potential stages of Monitoring compliance:- A = ACI reporting and collation of data. B = Annual audit/collation of data retrospectively. C = Ongoing prospective audit/data collection. D= Tri annual audit. E = Other. Monitoring Compliance (MC) Tool: Completed on 21/9/2010.By Jan Joseph.. POLICY TEMPLATE VERSION/DRAFT NO 1 PAGE 30 OF 34 Pai n Service

31 *Stage of MC required A,B,C Objective to be measured Number of line insertions and audit of adverse incidents/audit of infection rates Division / Department Responsible Lead Pain Management Service Frequency and/or timescale Yearly Audit Methodology Action Plan on Outcome POLICY TEMPLATE VERSION/DRAFT NO 1 PAGE 31 OF 34 Pai n Service

32 Gloucestershire Hospitals TRUST POLICIES Authorisation Form DOCUMENT: DEPARTMENT/DIVISION (WHERE APPROPRIATE) AND TITLE Authorisation Name and Position Date Approved Responsible Author Dr James DeCourcy Consultant in Anaesthesia & Pain Medicine Sr Jan Joseph Nurse Practitioner Pain Management Policy Sponsor Policy Assurers Consideration at authorised groups (e.g. Board, Board sub committees, Policy Group, Clinical Policies Sub Group, Departmental meetings etc.) Name of Group Minute Details Date considered POLICY TEMPLATE VERSION/DRAFT NO 1 PAGE 32 OF 34

33 Gloucestershire Hospitals EQUALITY IMPACT ASSESSMENT (Arial 12pt bold) INITIAL SCREENING 1. Lead Name : Jan Joseph Job Title : Nurse Practitioner Chronic 2. Is this a new or existing policy, service strategy, procedure or function? New Existing 3. Who is the policy/service strategy, procedure or function aimed at? Patients Carers Staff Visitors Any other Please specify: 4. Are any of the following groups adversely affected by this policy: If yes is this high, medium or low impact (see attached notes): Disabled people: No Yes Race, ethnicity & No Yes nationality: Male/Female/transgender: No Yes Age, young or older No Yes people: Sexual orientation: No Yes Religion, belief & faith: No Yes If the answer is yes to any of these proceed to full assessment. If the answer is no to all categories, the assessment is now complete. Date of assessment: 10/09/2010 Signature: Completed by: Jan Joseph Job title: Nurse Practitioner Chronic POLICY TEMPLATE VERSION/DRAFT NO 1 PAGE 33 OF 34

34 Director: Signature: This EIA will be published on the Trust website. A completed EIA must accompany a new policy or a reviewed policy when it is confirmed by the relevant Trust Committee, Divisional Board, Trust Director or Trust Board. Executive Directors are responsible for ensuring that EIA s are completed in accordance with this procedure. (Arial 11pt) POLICY TEMPLATE VERSION/DRAFT NO 1 PAGE 34 OF 34