Podiatric Surgery protocol: Local Anaesthesia. and Cortico-steroid injection therapy

Transcription

1 Podiatric Surgery protocol: Local Anaesthesia and Cortico-steroid injection therapy

2 Table of Contents Why we need this Policy... 3 What the Policy is trying to do... 3 Which stakeholders have been involved in the creation of this Policy... 3 Any required definitions/explanations... 3 Key duties... 4 Policy detail... 4 Local Anaesthesia... 4 Surgical Site Marking... 5 Field and Digital Blocks... 5 Ankle Block... 6 Nerve Stimulators... 6 Popliteal Block... 6 Anatomy... 7 Technique... 7 Goal... 7 Management... 8 Records... 8 Training requirements associated with this Policy... 9 Mandatory Training... 9 Specific Training not covered by Mandatory Training... 9 How this Policy will be monitored for compliance and effectiveness... 9 Equality considerations Document control details Appendix 1: Local Anaesthetic Administration Table Appendix 2: WHO Surgical Safety Checklist Appendix 3: CSITLOCAL STEROID INJECTIONS PIL APPENDIX D: COMPETENCY SIGN-OFF Page 2 of 20

3 Why we need this Policy The Podiatric Surgery service sits outside of the NGH/KGH district general hospital surgical directorates and structures and has a need to develop its own policies and protocols to support surgical practice. Below is a list specific to Podiatric Surgery: 1. Podiatric Surgery: standard operating procedures 2. Podiatric Surgery: pre-surgical assessment 3. Podiatric Surgery: diagnostic imaging requesting 4. Podiatric Surgery: diagnostic imaging - use of the mini C-arm 5. Podiatric Surgery: local anaesthesia and steroid injection therapy 6. Podiatric Surgery: prevention of venous thrombo-embolic disease 7. Podiatric Surgery: peri-operative management of diabetic patients 8. Podiatric Surgery: theatre protocols - maintaining privacy and dignity 9. Podiatric Surgery: theatre protocols surgery SOPs and LocSSIPs 10. Podiatric Surgery: theatre protocols post-operative discharge 11. Podiatric Surgery: post-operative consultations 12. Podiatric Surgery: clinical and surgical emergencies 13. Podiatric Surgery: COSHH register and risk assessments 14. Podiatric Surgery: research, audit and PASCOM What the Policy is trying to do This document outlines the Podiatric Surgery protocol developed to support the safe practice of local anaesthesia. Podiatric surgery is undertaken routinely by Consultant Podiatric Surgeon, his/her Registrar and/or trainee. In order to undertake this surgery safely and with the minimum of discomfort to the patient, a number of local anaesthetic agents are used. Which stakeholders have been involved in the creation of this Policy Podiatric Surgery Team Any required definitions/explanations NHFT - Northamptonshire Healthcare NHS Foundation Trust Page 3 of 20

4 MSD - Maximum Safe Dose Key duties The Medicines Management Committee Is responsible for Approving the protocol and any subsequent updates Consultant Podiatric Surgeon Is responsible for: Ensuring the protocol is reviewed when necessary Ensuring all staff working to the protocol are adequately trained Podiatry Team leaders Are responsible for Dissemination of the protocol Highlighting any areas of concern or non compliance to the Consultant Podiatric Surgeon Policy detail Local Anaesthesia Maximum safe dose (MSD) refers to the amount of drug that can be administered for therapeutic effect with minimum risk of adverse effects. It does not mean that there are no risks from drug administration at or below MSD. In estimating the safe dosage it is important to take into account the rate of absorption, the potency of the drug, and the vascularity of the tissues together with patient factors such as age, weight, and general health. Within the literature, and in different countries, there is some variation regarding published MSDs for local anaesthetic drugs both in plain solution and in combination with vasoconstrictors. This should infer that there is variation in opinion over the threshold set for a particular drug. We will use two formulas to calculate the MSD to produce an absolute dose in milligrams and a maximum safe volume in millilitres. We will use an approach common in podiatry: note that MSDs per body weight are not available for all drugs. For example, Naropin (ropivacaine hydrochloride) is marketed by AstraZeneca in the UK as a 2 mg/ml (0.2%), 7.5 mg/ml (0.75%), and 10 mg/ml (1.0%) solution. The British National Formulary lists the maximum safe doses as ml of a 7.5 mg/ml solution for a major nerve block and 30 ml of a 7.5 mg/ml solution for a field block. Page 4 of 20

5 The dilute preparations used in clinical practice are presented as percentage solutions of local anaesthetic. For example, lignocaine is available in 0.5, 1.0, 1.5 and 2% solutions for injection. A solution expressed as 1% contains 1g of substance in each 100mL. Maximum Safe Dose: Weight x drug MSD = MSD in 24 hours Maximum Safe Dosage by Volume: ml x 10 x % = mg Guidelines are at Appendix 1. Safe and Aseptic Practice Prior to any intervention the clinician must ensure that the patient is properly identified via a printed wristband and their identity confirmed together with allergy status. Strict aseptic conditions will be observed. Specifically, the clinician must ensure appropriate skin preparation prior to carrying out an invasive technique. Only the correct equipment as supplied by the manufacturer will be used in the preparation and administration of local anaesthesia. Surgical Site Marking Check procedure against consent and agree with patient, sign consent form. Mark the limb and the incision lines. Mark posterior leg as well as anterior if a pop block is to be performed Ensure that an MRSA screen has been performed and that prophylactic doses of antibiotics and heparin have been administered (see appendix 2). Patient monitoring is performed following local guidelines. The clinician should ensure that the following are readily accessible: Oxygen and mask Needles for cannulation Sphygmomanometer Pulse oximetry AED Anaphylaxis management Field and Digital Blocks Local infiltration of local anaesthetic is widely used in dermatological practice for the removal of superficial skin lesions. The digital block is a technically easy block to master and requires little Page 5 of 20

6 specific training though good technique will minimize the trauma to the patient and enhance reliability. The block is indicated whenever it is necessary to achieve anaesthesia of a single digit distal to the metatarsophalangeal joints. Ankle Block Tibial block o Palpate the posterior tibial artery o Direct the needle just inferior to the pulse until a paraesthesia or bone contact is encountered o If a paraesthesia is obtained, withdraw the needle slightly o If periosteum is contacted, withdraw the needle slightly, aspirate and inject an appropriate amount of anaesthetic Saphenous Nerve Block o The saphenous nerve is blocked with a sub-cutaneous infiltration on the dorsal foot - anterior to the medial malleolus (medial to the vein) - with an appropriate amount of local anaesthetic o Superficial Peroneal Nerve Block o Mark the point one finger breadth in from the lateral malleolus o Raise a subcutaneous injection, advancing the needle medially as you inject o Two passes of the needle are usually required, with appropriate amount of anaesthetic required Deep Peroneal Nerve Block (distal block) o Locate the dorsalis pedis (DP) artery o At 90deg to the foot, insert the needle deep to the periosteum, lateral to the DP artery o Aspirate and inject an appropriate amount of anaesthetic Sural Nerve Block o Block the sural nerve laterally between the lateral malleolus and the Achilles tendon with a subcutaneous fan infiltration of an appropriate amount of anaesthetic Nerve Stimulators A Nerve Stimulator is an inexpensive, practical and easy way to facilitate the location of nerves when performing blocks for regional anaesthesia or pain relief. A liquid crystal display indicates the value of the constant current output and incorporates a low battery warning. The large removable dial and all needle leads can be autoclaved to enable full sterile operation. When manipulating the needle a tone is heard with every pulse. The tone ceases should the needle or reference electrode become disconnected. Popliteal Block 1. Select the patient 2. Prepare the injection site 3. Prepare the equipment Page 6 of 20

7 4. Give the injection 5. Record drugs/dosages/batch No s 6. Record the ma at which the LA was delivered and that no resistance was noted on injection 7. Give (and record) aftercare advice Anatomy The following surface anatomy landmarks are used to determine the insertion point for the needle Popliteal fossa crease Tendon of biceps femoris (laterally) Tendons of semitendinosus and semimembranosus muscles (medially) Technique The needle insertion point is marked at 7cm above the popliteal fossa crease at the midpoint between the tendons It should be noted that these landmarks differ from those in the "popliteal fossa triangle" approach in that they are based on easily palpable anatomic structures, rather than on the imaginary lines of the "triangle Relying on the tendons of the biceps femoris and semitendinosus as landmarks makes this approach easily applicable, even in the obese patients The clinician is standing on the side of the patient with the palpating hand on the biceps femoris muscle The needle is introduced at the midpoint between the tendons - this position allows the clinician both to observe the responses to nerve stimulation and to monitor the patient The nerve stimulator should be initially set to deliver above 1.5 ma current because this higher current allows detection of the inadvertent needle placement into the hamstrings muscles and stimulation of the sciatic nerve through the epineural sheath as the needle is approaching its target When the needle is inserted in a correct plane, advancement of the needle should not result in any local muscular twitches; the first response to nerve stimulation is typically that of the sciatic nerve (foot twitch) Goal Visible or palpable twitches of the foot or toes at ma current Common peroneal nerve stimulation results in dorsiflexion and eversion Stimulation of the tibial nerve results in: plantar flexion and inversion Page 7 of 20

8 Management This technique is associated with minimal patient discomfort, because the needle passes only through the fat of the popliteal fossa A typical onset time for this block is minutes, depending on the type, concentration, and volume of local anaesthetic used The first signs of the onset of blockade are usually reported by the patient The foot "feels different" or an inability to wiggle toes is reported Sensory anaesthesia of the skin with this block is often the last to develop Inadequate skin anaesthesia despite the apparent timely onset of the blockade is common It may take up to 30 minutes to develop thus, local infiltration at the site of the incision by the surgeon is often needed to allow the surgery to proceed Records The clinician must complete the first section of the Surgical Safety Checklist (as appendixed) and handover the patient to the theatre team Task/ Function Corticosteroid (steroid) drugs treat pain, inflammation, certain types of arthritis and many other medical conditions. They can be used in injectable form and are helpful in treating many foot problems. Corticosteroids can be injected locally for an anti-inflammatory effect. In joint inflammation they are injected intra-articularly to relieve pain, increase mobility and reduce deformity in a single joint. Full aseptic precautions should be observed and any joint infection should have been excluded before injection therapy is initiated. See relevant PGDs: PGD 51 Triamcinolone.doc PGD 49 Depo-medrone with lidocaine.doc Technique 1. Select the patient 2. Prepare the injection site Page 8 of 20

9 3. Prepare the equipment (as per that for LA injection - O2, AED, adrenalin etc) 4. Give the injection 5. Record drugs/dosages/batch No s 6. Give oral and written aftercare advice (Appendix 3) 7. Review 6/52 or SOS Training Fellowship of the College of Podiatrists (Surgery) or attendance at a certificated Steroid Therapy course. Training requirements associated with this Policy Mandatory Training There is no mandatory training associated with this policy. Specific Training not covered by Mandatory Training Ad hoc training sessions based on an individual s training needs as defined within their annual appraisal or job description. How this Policy will be monitored for compliance and effectiveness The table below outlines the Trusts monitoring arrangements for this document. The Trust reserves the right to commission additional work or change the monitoring arrangements to meet organisational needs. Aspect of compliance or effectiveness being monitored Method of monitoring Individual responsible for the monitoring Monitoring frequency Group or committee who receive the findings or report Group or committee or individual responsible for completing any actions Duties To be addressed by the monitoring activities below. SOPs Inspection of a sample of Clinical Research Yearly Directorate Goverance Directorate Page 9 of 20

10 patient records Podiatrist Group Goverance Group Where a lack of compliance is found, the identified group, committee or individual will identify required actions, allocate responsible leads, target completion dates and ensure an assurance report is represented showing how any gaps have been addressed. Equality considerations Refer to MMP001 Control of Medicines Policy. Reference Guide Metcalfe S, Reilly I. Foot and Ankle Injection Techniques: A Practical Guide (Spiral-bound) Churchill Livingstone. Edinburgh. Heavner JE. Local anesthetics. Curr Opin Anaesthesiol : Page 10 of 20

11 Document control details Author: Ian Reilly - Consultant Podiatric Surgeon Approved by and date: Responsible committee: Medicines Management Committee Any other linked Policies: Policy number: MMpr018 Version control: 6 Version No. Date Ratified/ Amended Date of Implementation Next Review Date Review Reason for Change (eg. full rewrite, amendment to reflect new legislation, updated flowchart, minor amendments, etc.) Page 11 of 20

12 Appendix 1: Local Anaesthetic Administration Table This table is only a general guide. The MSD is the safe maximum dose over a 24 hour period and must be varied according to the patient s physiological status. LA Agent Mepivacaine (Scandonest) Plain Bupivacaine (Marcaine/ Chirocaine) Plain Prilocaine (Citanest) Plain Lignocaine Plain Lignocaine With Adrenaline* MSD for Drug (mg per kg) Concentration of Drug 6 3% 2 0.5% 6 4% 3 2% 6/7 (depending on ref) 2% Patient's Weight (kg) Patient s MSD (mg/24 hrs) MSV (ml) Ropivacaine: MSD Major nerve block (brachial plexus block), ADULT and CHILD over 12 years, ml of 7.5 mg/ml solution Field block, ADULT and CHILD over 12 years, 1 30 ml of 7.5 mg/ml solution * Concentrations of vasoconstrictors in local anaesthetics are expressed as dilutions for example, an adrenaline dilution of 1:100,000 means that there is 1g of adrenaline in every 100,000 ml of solution. Note that a 1:10,000 dilution is 10 times less concentrated than a 1:1,000 dilution, not 10 times more concentrated.

13 Appendix 2: WHO Surgical Safety Checklist Page 13 of 20

14 Appendix 3: CSITLOCAL STEROID INJECTIONS PIL Pre Injection Patient Information Leaflet (v31) Introduction This leaflet is designed as an aid to patients, offering general information relating to corticosteroid (steroid) injections and answering frequently asked questions. It does not attempt to answer all of your concerns. You are advised to ask the Podiatric Surgery team about any additional questions or concerns you have about your diagnosis or treatment. Local steroid injections (injections into an affected area, e.g. a joint or ligament) can be a quick and effective treatment for joint or soft tissue pain, swelling and stiffness. These injections have been tested and have helped many people. However, as with all drugs, some people may experience side-effects. What are steroids and how are steroid injections used? A corticosteroid (or cortisone ) is an anti-inflammatory medicine which can be injected directly into the tissues that are causing your symptoms. It is a safer alternative to taking anti-inflammatory medication by mouth. It acts directly in the area injected and is not the same as the steroids taken by bodybuilders or athletes. Steroid injections into a joint are often recommended for people with rheumatoid arthritis and other types of inflammatory arthritis. They may also be recommended for osteoarthritis (a wear and tear condition) if your joints are very painful. Severe pain experienced when a nerve in the foot becomes irritated and thickened (i.e. Morton s neuroma) can also be reduced by steroid injections. They are also used for plantar fasciitis, scars and soft tissue growths. The injection reduces inflammation, which in turn will reduce pain. What steroid preparations are available? A number of different steroid preparations are available for injection and your Consultant will choose the preparation and the dose most appropriate to your needs. The mildest is hydrocortisone. Prednisolone, methylprednisolone and triamcinolone are stronger and tend to be less soluble (dissolve less easily), remaining in the joint/soft tissue for longer. The clinical benefit from the stronger drugs is associated with a slightly increased risk of local side-effects. In order to make the injection more comfortable for you, local anaesthetic is sometimes used prior to the steroid injection or can be mixed with the steroid. The local anaesthetic will make the area numb within minutes and may last for up to 24 hours. Is there any time when I should NOT have an injection? Yes, if you: 1. Do not want the injection 2. Are allergic to steroids or local anaesthetic 3. Have an infection in the area to be injected or anywhere else in your body 4. Feel unwell (i.e. have a cold/fever) 5. Are on antibiotic therapy 6. Are on anti-fungal medication 7. Are on anti-retrovirals (medicines to control HIV) 8. Have had live vaccines (MMR, polio, yellow fever, typhoid, TB) within the last 4 weeks or have had active TB within the last 10 years 9. Have heart failure 10. Are due to have surgery to the area soon 11. Are under 18 years old Page 14 of 20

15 12. Have poorly controlled diabetes What are the risks and possible side-effects? Common side-effects (may affect up to 1 in 10 people) Soreness/bruising from a steroid flare (unpredictable local reaction) at the site of injection. This can occur 4-12 hours after the injection but normally wears off in less than 72 hours. Take over-the-counter painkillers (i.e. paracetamol) and apply ice to the area to ease the pain Increase of pain at the injection site (for up to seven days) Small area of fat loss (skin dimpling) at the site of injection Change in skin colour around the site of injection Light headedness Temporary bruising or bleeding at the site of injection (especially if you are taking blood thinning tablets such as aspirin or warfarin) Flushing or redness of the face for a few hours up to hours Calcification around the injected joint Rare Diabetic patients may notice a temporary increase (a few hours) in blood sugar levels Haematoma (localised collection of blood) at the site of injection Fainting Worsening pain i.e. from irritation of a nerve by the injection needle Very rare Infection at the site of injection. If the area becomes red, hot, swollen and painful for more than 24 hours, or if you feel generally unwell, you should contact your Podiatric Surgery Team immediately. If they are unavailable, you should seek advice from your GP or Accident & Emergency (A&E) department Convulsion (fits) Cardiac arrest (stopping of the heart) Anaphylactic reaction (i.e. a serious allergic reaction) Slight vaginal bleeding/menstrual irregularities. If it lasts longer than one cycle you should see your doctor Tendon rupture FREQUENTLY ASKED QUESTIONS Is there an alternative treatment to local steroid injections? The only alternative to a local injection is to take anti-inflammatory pain killing tablets; however you may well have already been using these to help with your pain. These tablets often do not reduce the pain to a point where your foot is comfortable, which is why an injection is then the treatment of choice. Who will do the local steroid injection? A specially trained Podiatrist will do the injection after you have given your verbal consent. How to prepare for the local steroid injection? Your appointment for treatment will be arranged after a consultation in our clinic. You should eat and drink normally and arrive for your treatment on time and accompanied by an adult (a relative or a friend). You should take a shower before your treatment and must not apply cosmetic products on your feet. You should not apply any cream or rub which you might have been prescribed for reduction of your pain. Page 15 of 20

16 How is the local steroid injection done? Most injections are quick and easy to perform. In some cases fluid will be removed from the area (i.e. joints or ganglions) before the injection is given. For the steroid to be injected into a precise spot, an ultrasound scan or an x-ray may be used. You will not be required to wear protective x-ray covers. Sometimes you may be referred to have the steroid injection done under ultrasound. What happens on the day? You will be taken to the treatment room and your blood pressure and heart rate will be checked. You may be asked to remove some clothes. You will be positioned either sitting or lying down on a couch. Your skin will be wiped with a sterilising solution. A needle will gently be positioned into the affected area and the steroid solution will be injected through the needle. During the injection you may have a sensation of stinging, pressure and slight discomfort for a very short while. After the injection, the site will be covered with a small dressing, usually a plaster. The dressing protects the area from injection and needs to stay on your skin for 24 hours. During that period you should not wet the injection site. What happens immediately after the local steroid injection? You may be asked to rest for up to 30 minutes after the injection before you can go home. You should have someone to drive you back home. You should try and rest for the first hours days after the injection and avoid any activities that normally make your symptoms worse. This reduces the chance of a post-injection flare and will help the steroid work. What to expect afterwards? Local anaesthetic and steroid injections are usually very well tolerated and you can go back to work the next day. You may have a sensation of numbness in the treated area immediately after the injection which may last for up to two hours. You may be sore at the site of injection for up to 48 hours and you should take your usual painkillers or antiinflammatory tablets as advised by your doctor. You should refrain from strenuous work and extreme heat (like that in a sauna or steam room) for 48 hours. A general principle is to move the joint injected as normal but do not lift or push heavy objects after the injection. How quickly will the local steroid injection work? This varies with individuals but most people report improvement of their symptoms within 24 to 48 hours. It can, however, take a few days or even weeks before any change is noticed and some patients gain little if any benefit from their use. In this case, a repeat injection may be recommended. Can I drive afterwards? No. You will not be allowed to drive on the day of your treatment. Can I go straight back to work? No. It is advisable to take a day off work. You should rest for 12 to 24 hours after the injection. If your work involves heavy lifting, then try to reduce the workload over the next seven days. How long will the effects last? Your steroid injection is part of your treatment plan and it aims at breaking your pain circle. The effects vary from person to person. The less soluble steroids may take around a week to become effective but improvements can last for weeks or months, and in some cases longer or permanently. However, there is no guarantee that the injection will work for you. If you have had previous injections and they have not lasted, then your condition will be reassessed and a new treatment plan will be decided with your clinician. Page 16 of 20

17 Will I have a follow-up appointment? You will be reviewed 6 weeks after the steroid injection. How many local steroid injections will I need? You may need more than one injection. If symptoms persist, your clinician may decide to inject again. There are a maximum number of times (usually 3 injections spaced over one year) that soft tissues or joints should be injected and, if necessary, the clinician will discuss this with you. Can I take other medicines along with the local steroid injection? You can take other medicines with local steroid injections. However, if you are taking a drug that thins your blood (an anticoagulant) such as warfarin, you may need an extra blood test to make sure that your blood is not too thin to have the injection. This is because of the risk of bleeding into the joint. You should mention that you take anticoagulants to the person giving the injection to make sure that they are aware. If you discuss this beforehand, you may be advised to adjust your warfarin dose before having the steroid injection. If you are having other medical treatment within six weeks, you should inform the treating clinician that you have received a local steroid injection. Can I drink alcohol if I have been given a local steroid injection? Yes. There is no particular reason to avoid alcohol after an injection. What happens if I have diabetes? You will need to keep a closer eye on your blood sugars for 48 hours as the sugar levels often rise and you may need more insulin than normal (if you use insulin). Contact your diabetes specialist for advice if your blood sugar is high. I am on biologic therapies does that matter? You can still have a steroid injection in your foot if you are taking anti-tnf therapy or other biologic therapies. You must be especially quick to let us know if you have any signs of infection. The infection could be worse because you are taking a medication that affects your body s natural defences against infection. Will the local steroid injection cause side-effects throughout my body (i.e. weight gain, osteoporosis)? No. The injection contains a very low dose of steroid and because of its special preparation it will not spread significantly through the body. Can I have immunisations after a local steroid injection? Yes. Can I have a local steroid injection if I am pregnant, trying to get pregnant or breastfeeding? Current guidelines state that steroids are not harmful in pregnancy or breastfeeding so single steroid injections should not affect fertility, pregnancy or breastfeeding. However, if you are pregnant or breastfeeding, you should discuss with your clinician before having a local steroid injection. Contact us If you have any questions or concerns about local corticosteroid injections, please contact the Podiatric Surgery team at Battle House on (01604) between the hours of 8:30am 5pm, Monday to Friday and leave a message for one of the clinicians to contact you. ian.reilly@nhft.nhs.uk. Page 17 of 20

18 Post Injection Patient Information Leaflet (v32) You have just received a corticosteroid (steroid) injection. The steroid reduces the swelling and pain you have in your foot. Date seen in clinic: By clinician: Location: Battle House / Isebrook Hospital / Danetre Hospital Patient Name/DoB: Steroid given: Dose: Addressograph Label Batch no: Expiry date: Local anaesthetic given: Dose: Batch no: Expiry date: Injection site: Contact us If you have any questions or concerns about local corticosteroid injections, please contact the Podiatric Surgery team at Battle House on (01604) between the hours of 8:30am 5pm, Monday to Friday and leave a message for one of the clinicians to contact you. ian.reilly@nhft.nhs.uk If you feel it is urgent and you need to contact someone outside of these hours, telephone your GP, Out of Hours service or attend Accident and Emergency at your local hospital. Page 18 of 20

19 What are the risks and possible side-effects? Common side-effects (may affect up to 1 in 10 people) Soreness/bruising from a steroid flare (unpredictable local reaction) at the site of injection. This can occur 4-12 hours after the injection but normally wears off in less than 72 hours. Take over-the-counter painkillers (i.e. paracetamol) and apply ice to the area to ease the pain Increase of pain at the injection site (for up to seven days) Small area of fat loss (skin dimpling) at the site of injection Change in skin colour around the site of injection Light headedness Temporary bruising or bleeding at the site of injection (especially if you are taking blood thinning tablets such as aspirin or warfarin) Flushing or redness of the face for a few hours up to hours Calcification around the injected joint Rare Diabetic patients may notice a temporary increase (a few hours) in blood sugar levels Haematoma (localised collection of blood) at the site of injection Fainting Worsening pain i.e. from irritation of a nerve by the injection needle Very rare Infection at the site of injection. If the area becomes red, hot, swollen and painful for more than 24 hours, or if you feel generally unwell, you should contact your Podiatric Surgery Team immediately. If they are unavailable, you should seek advice from your GP or Accident & Emergency (A&E) department Convulsion (fits) Cardiac arrest (stopping of the heart) Anaphylactic reaction (i.e. a serious allergic reaction) Slight vaginal bleeding/menstrual irregularities. If it lasts longer than one cycle you should see your doctor Tendon rupture Page 19 of 20

20 Appendix D: Competency Sign-Off Team Member Trainer Competency Achieved.... Ian Reilly MSc FCPodS DMS Consultant Podiatric Surgeon I confirm that the signatory is competent in the skills and behaviour needed to effectively perform in this role. / /... Ian Reilly MSc FCPodS DMS Consultant Podiatric Surgeon Page 20 of 20