FACULTY OF PAIN MEDICINE

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1 PM4 (2005) FACULTY OF PAIN MEDICINE AUSTRALIAN AND NEW ZEALAND COLLEGE OF ANAESTHETISTS ABN GUIDELINES FOR PATIENT ASSESSMENT AND IMPLANTATION OF INTRATHECAL CATHETERS, PORTS AND PUMPS FOR INTRATHECAL THERAPY 1. INTRODUCTION: 1.1 Persistent pain with associated disability is a common problem. (1) 1.2 In all patients with persistent pain, appropriate evaluation requires assessment of physical, psychological and socio-environmental factors. (8) 1.3 Treatment of only one dimension of the patient s pain is likely to result in a less than optimal outcome. (3) 1.4 Intrathecal drug administration is an established and often effective method of pain management in a small subgroup of patients with cancer and persistent non-cancer pain. (5,9) 1.5 Intrathecal treatment may provide a unique opportunity to directly target central sensitisation associated with cancer and persistent non-cancer pain. (2) 2. PRINCIPLES OF USE : (3,6) 2.1 Patients must have a clinical diagnosis for their pain. 2.2 Intrathecal therapy may be considered for conditions unresponsive to more conservative treatment modalities, or in those where other routes of medication cause intolerable side effects. 2.3 Caution must be exercised where psychological factors are considered to be a major pain-modifying factor. 2.4 Consent covering the nature of this treatment, the trial and insertion procedure, potential adverse outcomes, and limitations imposed by continuation of treatment is essential. (9)

2 2.5 Psychological evaluation is essential Identify psychological and psychiatric disorders Ensure adequate exposure to appropriate psychological therapies Prepare the patient for the psychological sequelae of intrathecal therapy, reinforcing realistic expectations. 2.6 Ensure the patient agrees to comply with restrictions and requirements associated with this type of treatment. 2.7 Patients should have explored and been educated in the benefits of all other conservative therapies, including where appropriate: (6) Physical therapies Psychological therapies Oral and parenteral medication as appropriate Neural blockade. 3. METHOD OF ASSESSMENT: 3.1 A Multidisciplinary assessment must be undertaken before proceeding to insertion of an intrathecal drug delivery system. Multidisciplinary treatments should continue for the duration of therapy. (3,8) 3.2 Prior to the insertion of a long-term intrathecal delivery system, the following should be considered. (3,6) The treating physician must be familiar with the therapy and device to be utilised An appropriately planned trial of intrathecal therapy with consideration of a placebo arm is recommended. This will allow documentation of the efficacy of the therapy and potential side-effects of the drugs administered Pain scores, and measures of, function, mood and side effects should be recorded. (8) 3.3 Absolute and relative contra-indications to the insertion of a long-term intrathecal delivery system should be considered and discussed: Absolute contra-indications: Failure of trial Systemic infection Sensitivity to components of the delivery system Inadequate psychosocial support and / or coping mechanisms.

3 Relative contraindications may include (3) : Immunocompromised patients Patients on anticoagulants / bleeding diathesis Psychiatric disorders Geographically or socially isolated Poor compliance or understanding of therapy Evidence of current drug abuse. 4. PRINCIPLES OF LONG-TERM INTRATHECAL DELIVERY SYSTEMS: 4.1 Implantation of intrathecal devices requires a full aseptic environment, competent surgical skills and adequate anaesthesia by a separate specialist. 4.2 Preoperative planning will identify the appropriate intrathecal device, to ensure ease of ongoing care, with appropriate supply of medication. 4.3 Catheter placement should be checked by image intensifier during the procedure. 4.4 Medication prescription should be selected, written and checked prior to pump insertion. Before instillation into the pump it should be rechecked by a second individual. 4.5 For better quality control of medication, consideration should be given to the prescription being prepared by a manufacturing pharmacy. 4.6 Care should be taken when considering off label use of drugs ensuring that additional patient education and consent are obtained. (10) 4.7 Institution of intrathecal therapy with opioids can cause postoperative respiratory depression. Doses should be titrated carefully with regular observations particularly in the first 24 hours. 4.8 There should be an appropriate plan for rationalisation of other medication including opioids to avoid symptoms of over dosage or withdrawal. 5. LONG TERM PATIENT MANAGEMENT: 5.1 At each refill an assessment of analgesic effect, level of function, side-effects and complications is necessary. (4) 5.2 A medical practitioner must be readily available to assess progress and advise therapy changes. 5.3 An appropriately trained health care professional should perform refills An aseptic technique is essential Appropriate resuscitation equipment must be available.

4 References: Concurrent rehabilitation programs, cognitive behavioural pain management programs and exercise programs should be encouraged to improve function post implantation. 5.5 Long term efficacy, complications and side effects must be monitored using standard measures. Appropriate documentation is necessary for individual patient management and quality improvement. 5.6 Multicentre outcome data should be collected to assess overall patient satisfaction, improvement in quality of life and reduction in disability. (4) 5.7 Continued basic research will clarify the role of future development of intrathecal therapy devices, with information about pharmacodynamics and cerebrospinal fluid dynamics of drugs administered intrathecally. (9) 1. Blyth FM, March LM, Brnabic AJ et al: Chronic Pain in Australia: a prevalence study: Pain: 2001: 89: Carr DB, Cousins MJ: Spinal route of analgesia opioids and future options: Cousins MJ, Bridenbaugh PO (Eds): Neural Blockade in Clinical Anesthesia and Management of Pain. Third ed. Philadelphia: Lippincott-Raven: 1998: Deer T, Winklemuller W et al: Intrathecal therapy for cancer and non-malignant pain: Patient selection and management: Neuromodulation: 1999: 2 (2): Deer T, Chapple I et al: Intrathecal drug delivery for treatment of chronic low back pain: Report from the national outcome registry for low back pain: Pain Medicine: 2004: 5(1): Molloy A: Implanted drug delivery systems: Optimising outcomes: Refresher course RO8: IASP Paice JA, Penn RD, et al: Intraspinal morphine for chronic pain: a retrospective, multicenter study. J Pain Symptom Manage: 1996:11(2): Tutak U Doleys DM. Intrathecal infusion systems for treatment of chronic low back and leg pain of noncancer origin. South Med J :1996: 89: Wallace M, Yaksh T: Long-term spinal analgesic delivery: A review of the preclinical and clinical literature: Regional Anesthesia and Pain Medicine:2000: 25(2): Winkelmuller M, Winkelmuller W. Long-term effects of continous intrathecal opioid treatment in chronic pain of nonmalignant etiology. J Neurosurg: 1996: 85: Off-Label Use of Registered Medicines and Use of Medicines under the Personal Importation Scheme in NSW Public Hospitals. NSW Therapeutic Advisory Group: use%20of%20registered%20medicines.pdf Accessed

5 5 FACULTY OF PAIN MEDICINE PROFESSIONAL DOCUMENTS POLICY defined as a course of action adopted and pursued by the Faculty. These are matters coming within the authority and control of the Faculty. RECOMMENDATIONS defined as advisable courses of action. GUIDELINES defined as a document offering advice. These may be clinical (in which case they will eventually be evidence-based), or non-clinical. STATEMENTS defined as a communication setting out information. This document has been prepared having regard to general circumstances, and it is the responsibility of the practitioner to have express regard to the particular circumstances of each case, and the application of this policy document in each case. Professional documents are reviewed from time to time, and it is the responsibility of the practitioner to ensure that the practitioner has obtained the current version. Professional documents have been prepared having regard to the information available at the time of their preparation, and the practitioner should therefore have regard to any information, research or material which may have been published or become available subsequently. Whilst the College and Faculty endeavours to ensure that documents are as current as possible at the time of their preparation, they take no responsibility for matters arising from changed circumstances or information or material which may have become available subsequently. Promulgated: 2005 Date of current document: July 2005 This document is copyright and cannot be reproduced in whole or in part without prior permission. Faculty Website: