Spinal Analgesia for Palliative Care

Spinal Analgesia for Palliative Care

Overview of Spinal Analgesia Prof Lesley Colvin Consultant/ Hon Professor in Anaesthesia & Pain Medicine Cancer pain: is it a problem? 80% of patients with advanced cancer- significant pain (Addington-Hall and McCarthy 1995;Millar, Carroll et al. 1998) Good supportive care and appropriate analgesia:15-20% of patients - uncontrolled pain (Zech, Grond et al. 1995;2000), (Ventafridda, Tamburini et al. 1987) Severe pain Closely linked with mood and distress Projected increase in incidence of cancer + decrease

in mortality (Cancer in Scotland, 2001) Cancer Pain Tumour infiltration Nerve damage Bone metastases Cancer treatment Inflammation Peripheral & Central Nervous System response Cancer Pain: Clinical Challenges Pain

assessment Neuropathic pain Drug related side effects Breakthrough pain Improving basic pain assessment Edinburgh Pain Assessment and management Tool (EPAT) Does use of a bedside assessment tool improve pain control? Step 1 Warning Flags

E Step 2 P Education Prompts A Programme T EPAT Pilot study: Prospective, n=200 3 wards randomized to 3 different pain assessment methods; Outcome: pain <4, Day 3 Standard care 55% of patients BPI 65% EPAT 90%

Multicentre study: improved pain control without increased side effects Fallon, M, Walker, J, Colvin, L, Rodriguez Carbonell, A, Murray, G & Sharpe, M 2018, 'Pain management in cancer center inpatients: a cluster randomised trial to evaluate a systematic integrated approach (the Edinburgh Pain Assessment and Management Tool, EPAT (c))' Journal of Clinical Oncology. DOI: 10.1200/JCO.2017.76.1825 Management Options WHO ladder Escalation/rotation opioids

Adjuvants Invasive therapy Coeliac plexus block Spinal analgesia Adjuvan ts

Assessment of cancer pain Side Efficacy Opioid/ adjuvant effects titration Reassessment Spinal analgesia Central neural block Epidural/ intrathecal analgesia Spinous process

Spinal cord Arachnoid mater Dorsal root Dura mater Ventral root Vertebral body Treatment algorithm for intrathecal analgesia patient selection The Polyanalgesic Consensus Conference (PACC): Recommendations on Intrathecal Drug Infusion Systems Best Practices and Guidelines, Neuromodulation 20(2), 96-132: 2017)

Treatment algorithm for intrathecal drug delivery for cancer pain Patient selection Difficult to control pain Locally advanced disease Incident pain/ neuropathic pain Side effects from systemic analgesia Prognosis Can be very difficult to assess What does the patient want? Consider home circumstances/ support Patient selection Pre-implantation trial to assess Analgesic benefit

Functional improvement Adverse effects High dose responders; younger patients, non- cancer pain More rapid dose escalation Increased use of adjuvants Consider need for psychological support before and after implantation Advantages of central route Lower dose needed for same effect Drug delivery close to site of action Minimise side effects Control of incident pain

Flexibility for addition of adjuvant agents Contraindications (relative) Acute cord compression Abnormal clotting Sepsis local vs. systemic Known allergy Potential complications Procedural Pharmacological CSF leak dural puncture Infection Haematoma Catheter factors

Placement Movement Block or fracture Infection (2-8%) factors Acute tolerance Withdrawal Toxicity Urinary retention Pruritis Central neural blockade: agents Standard mix: Local anaesthetic

Incident pain Opioids dose conversion - variable (1/100th systemic dose for intrathecal) hydromorphone Clonidine Neuropathic pain Alternatives: Ketamine Midazolam Ziconotide Catheter placement Placement Positioning

Asepsis Iv access and monitoring Dose conversion Epidural 1/10 of systemic dose 45mg (eg 9ml 0.5%) bupivacaine + 75mcg clonidine + hydromorphone Intrathecal 1/10 of epidural dose Patient care 1st 24 hrs Leave iv access in situ Bed rest if dural puncture Potential problems Respiratory depression

Solutions Infection Urinary retention Haematoma Hrly Resp rate; stop long

acting opioids; Naloxone available ?Prophylactic antibiotics catheter Signs of cord compression Cover with sterile swab, replace filter and line Patient care after 1st 24 hrs Assess pain rest and movement Leg weakness and postural hypotension Infusion device

Use what is FAMILIAR AND SAFE Eg Graseby or McKinley Clearly labelled/ colour coded Change syringe daily Filters dual system decreased infection Infusion volume Both epidural and intrathecal 22ml in 30ml syringe over 24 hr- vary concentration Evidence RCT of implantable drug delivery system cf

comprehensive medical management for refractory cancer pain: impact on pain, drug-related toxicity, and survival T. J. Smith, P. S. Staats, T. Deer, and et al. Journal of Clinical Oncology 20:4040-4049, 2002 N=200 patients, 4 weeks: IDD mean VAS pain score - 51.5% reduction cf standard medical management 39.1% reduction Greater proportion of patients survived at 6 months in the IDD group (53.9%) compared with the standard medical management group (37.2%) Education and evaluation

Formal training Formal assessment intrathecal register Approved documentation and systems in place Consider central registry/ database Questions? Patient Mrs B 43-yr-old woman Presented with tiredness and

epigastric pain Investigations MRI: pancreatic tumour Mrs B: Oncological Treatment Interventions included

ERCP/Stent Hepaticojejunostomy Tumour not resectable 2nd opinion elsewhere Chemotherapy Clinical Course Admitted to hospice for symptom control Severe pain, low mood Diamorphine subcut.

200mg/24hrs + prn Request for pain intervention (spouse) Options? WHO ladder Escalation/rotation opioids Invasive therapy

Coeliac plexus block Spinal catheter What happened? Pain assessment: Opioid toxic (sedated, confused) Poor pain control Tunnelled epidural catheter Patient discharged home with regular nursing support Able to go on cruise and visit family around UK (had previously wanted to die)

What next? CT showed no improvement from chemotherapy Line fell out managed on oral opioids (rotation) Implanted intrathecal pump Holidays in Portugal, Paris and UK Died at home 4 years after initial presentation Important points Prognosis is very difficult to judge Severe pain interlinked with mood and distress Pain progression not inevitable Good supportive care and timely intervention BUT....

Expensive & labour intensive..? Prison Healthcare Jillian Galloway Dawn Wigley David Morrison Clair Petrie Prison Healthcare Jillian Galloway Dawn Wigley David Morrison Clair Petrie HMP Perth

Capacity for approx 650 prisoners Annual turnover approx 3000 prisoners Remand, Short Term, Long Term and Protection (offence and non offence) HMP Castle Huntly Open Estate National Facility Capacity for approx 285 prisoners Annual turnover approx 500 prisoners Long Term prisoners low supervision assessed as being fit for open conditions PHC Provides Primary and some Secondary Health care services to the population of both Tayside Prisons and we are striving to deliver equitable healthcare to that delivered in the community across Tayside

Assess All New Prison Admissions GP SPS Talk to Me Responsibilities Primary Care Nurses Medicines Administration Pharmacy Team Morning approx 260 patients Public Health Nurse

Mental Health Team (CDs and detox) Substance Misuse Team Evening approx 61 patients Case Work Addictions Team (CDs, detox, acutes) Visiting Podiatrist Emergency Response Visiting Dentist Attend all Incidents of Prisoner Visiting Optician Restraint Local Priorities Provide Safe, Effective and High Quality Care Support Rehabilitation and Recovery (not just from a health perspective)

Enabling infrastructure, workforce and organisational culture Joined up pathways between primary and secondary care and between clinical services Prevention, maintaining existing health through anticipation, co-production and self management Delivering Palliative Care in Prisons Prisoners are entitled to the same medical care as those in the community Framework and action plan 2014 Living and Dying Well Promoting High Quality Care for ALL adults at the end of life HMP Perth have had 4 palliative patients in the last 12 months Currently have 2 palliative patients

How do we Care for Palliative Patients in a Custodial Environment? Aim to provide pain and symptom relief Total Pain Physical Social Psychological Spiritual Needs Palliative Care Pathway in place within PHC to provide care for patients with palliative care needs What are our challenges in delivering palliative care within custodial environment?

Nurse Educat ion Officer Confid ence re dying patient Out Reach Suppo rt Challe Symptom Management

Access to appropriate services within the SPS regime nges Communicatio n between NHS and SPS Complex Population Options Care for them in custodial environment they are in Compassionate release

Transfer to hospital or hospice What should patients expect? Open, honest communication should happen with healthcare staff about their needs and wishes as people near the end of your life. A care plan should be made taking into account those needs and wishes. Every service provider involved in your care must communicate with each other so that your care is coordinated. This includes prison officers and the healthcare team. Care has to be of a high standard no matter where its happening. Prison healthcare staff should be aware of your condition, they also need to consider your emotional and physical needs. Prisoners that are close to, or caring for those with a terminal illness, should be given support where possible. Family and other prisoners will be told when someone has died. Synchromed II programmable

implantable drug pump Medtronic Neuromodulation Learning Objectives Describe the NVision Clinician Programmer Describe the Synchromed II programming strategy Demonstrate programmer functions Exercises

Practice using clinician programmer functions 43 | MDT Confidential Intrathecal Therapy Why? Drug dose intrathecally 1/300th oral Minimise side effects and reduce systemic dose and oral meds

Programmable pump allows varied infusion rates/regimens to reflect pain pattern Cost-effective Treatment of chronic pain by using intrathecal drug therapy compared with conventional pain therapies: a cost-effectiveness analysis. Kumar K, Hunter G, Demeria DD. J Neurosurg. 2002 Oct;97(4):803-10 44 Intrathecal Therapy Synchromed II Pump Indications

Chronic infusion of Lioresal Intrathecal (baclofen injection) for the management of severe spasticity of spinal or cerebral origin Chronic intrathecal or epidural infusion of sterile, preservative-free morphine sulfate for chronic, intractable pain of malignant and/or non-malignant origin Chronic intrathecal infusion of preservativefree ziconotide sterile solution for the management of severe chronic pain Medtronic Synchromed II Infusion System: Information for Prescribers.

http://professional.medtronic.com/pt/neuro/itb/prod/synchromed-ii/features-specifications/index.htm 45 | MDT Confidential 45 Intrathecal Therapy In reality. Multiple-drug combinations for pain are common Baclofen is used in multiple dilutions 46 | MDT Confidential

500, 1000, 1500, 2000, 3000mcg/ml Polyanalgesic Consensus Conference 2012: recommendations for the management of pain by intrathecal (intraspinal) drug delivery: report of an interdisciplinary expert panel. Deer TR, Prager J, Levy R, Rathmell J, Buchser E, Burton A, Caraway D, Cousins M, De Andrs J, Diwan S, Erdek M, Grigsby E, Huntoon M, Jacobs MS, Kim P, Kumar K, Leong M, Liem L, McDowell GC 2nd, Panchal S, Rauck R, Saulino M, Sitzman BT, Staats P, Stanton-Hicks M, Stearns L, Wallace M, Willis KD, Witt W, Yaksh T, Mekhail N. Neuromodulation. 2012 Sep-Oct;15(5):436-64; discussion 464-6. doi: 10.1111/j.15251403.2012.00476.x. Epub 2012 Jul 2. 46 Synchromed II Overview System Components:

Programmable pump 20 and 40ml reservoirs Catheter One or two piece Physician Programmer The Pump Catheter Access

Port (CAP) 2 D barcode (tracking) Test hole (used to test top shield weld integrity) 48 | MDT Confidential Inside Synchromed II Internal tubing Peristaltic pump Motor Battery Refill Port Hybrid

Ascenda Catheter Design: Summary of Benefits Polyurethane Outer Layer Silicone Inner Layer Resistance to leaks and breaks Drug compatible Thermoplastic PET Braid 50 | MDT Confidential INTERNAL USE ONLY

Six times stronger than our previous silicone catheters Offers improved resistance to kinking and occlusions Implantable components SynchroMed II infusion pump

Stores and precisely delivers baclofen at rate tailored to each individual patient Wide range of programmable parameters and modes Prescriptions can be programmed for combinations of bolus and continuous infusion doses Battery-powered: Two reservoir sizes:

20 and 40 ml Thin profile with contoured shape for comfort: Longevity up to 7 years at 0.9 ml/day Width 20 vs. 40 ml pump: 19.5 mm vs. 26 mm Contains alarm to indicate need for refill or pump replacement Implantable components How SynchroMed II infusion pump works

Bellows design allows reservoir to expand/contract according to drug volume At normal body temperatures: Battery-powered electronics and motor cause roller arm in peristaltic pump to rotate Precisely pushes programmed dose through catheter port and into catheter

Valve protects pump reservoir from being over-filled or over-pressurized CAP allows direct access to catheter and CSF and may be used for diagnostic tests Pressurized gas in space below reservoir expands and exerts constant pressure on reservoir Drug advances into pump tubing Catheter Access Port (CAP) has funneled design that only allows 24-gauge or smaller needle to pass through Safety feature that helps prevent inadvertent access during pump refill procedures (uses 22-gauge needle)

Equipped with suture loops to secure pump in pocket site Implantable components Catheter Thin, elastic and flexible tube Made of durable radiopaque silicone rubber

Trimmable at pump end of placed catheter Sutureless pump connector Delivers baclofen from pump to intrathecal space Facilitates connection to pump Spinal end of catheters has closed tip and side holes for drug delivery Marked at 1-cm increments to aid catheter

placement Guide wire in lumen: Provides additional stiffness and catheter tip control during placement Synchromed II in detail (2) Programmin Simple continuous, flexible g options dosing, patient activated bolus, minimum infusion rate Pump data log Patient demographics, drug details, catheter information,

time stamped event log MRI Up to 3 Tesla Compatibilit y Alarm functions Critical alarm: end of service, empty reservoir, stalled pump, critical memory error, stopped pump duration exceeded Non-critical alarm: low reservoir, elective replacement indicator (90 days pre-EOS)

Programming options Simple Continuous mode Single bolus continuous Flex mode External component NVision programmer

Handheld portable device Allows physicians to program pump and tailor therapy to patient Weighs 680 g Uses AA batteries Contains: Touch screen display with icon-based navigation for data entry

Telemetry module for device programming Integrated calculator Infrared port through which communications can be established with compatible printers Single programming platform NVision Programmer NVision clinician programmer communicates with pump via telemetry

Radio-frequency (RF) communication SynchroMed EL pump requires Model 8529 magnet Attaches to programming head 61 | MDT Confidential

NVision Programmer The pump is programmed during: System implant (initial pump fill) Patient management

Optimize therapy Pump refill with same drug and drug concentration Change drug or drug concentration Troubleshooting 62 | MDT Confidential Programming Features SynchroMed II Pump > Full patient information Includes name and address

> Pump serial and model numbers > Catheter information Model number Catheter volume > Drug information > > > >

Name (25 characters) Concentration Infusion prescription Calibration constant Notes Event logs SynchroMed EL Pump > > > Patient ID (3 characters) Pump model number Catheter information

> Drug Information > > Model number Catheter volume Name (5 characters) Concentration Infusion prescription

Calibration constant Note: Telemetry takes 30-90 seconds because of the amount of information transmitted 63 | MDT Confidential Programming Features AlarmsPump sounds an alarm when certain events occur: SynchroMed II Pump > Critical alarm3-second, 2-tone

Empty reservoir End of Service (EOS) Motor stall Stopped pump exceeds 48 hours Critical pump memory error SynchroMed EL Pump > 1-tone alarm Low reservoir volume reached Low battery

> 2-tone alarm Pump memory error > Non-critical alarm1-second, single-tone Low reservoir volume reached Elective Replacement Indicator (ERI) Non-critical pump memory error 64 | MDT Confidential Calibration Constant

Number of electrical pulses required for specific pump to dispense one mcL (L) of fluid Specific value for each pump determined during manufacturing Displayed on Pump Status screen of NVision clinician programmer Verify before implant

Match calibration constant printed on pump package Troubleshoot pump Match calibration constant written in patient record or printed on patient ID card 65 | MDT Confidential Prepare for Programming Session 1. 2. 3.

Ensure software application card is inserted Turn the programmer on Check programmer battery status 4. Install batteries if needed Select the Pump Application button 66 | MDT Confidential Prepare for Programming Session

2. Select Synchromed II demo 3. Select Interrogate 67 | MDT Confidential Overview Screen This screen shows:

Pump in shelf state (for a new pump), serial number, model number and calibration constant. Minimise screen using small cross 68 | MDT Confidential Questions? 69 | MDT Confidential Intrathecal Drug Delivery By Jennifer Gray Specialist Clinical Pharmacist Neurosurgery, Pain and Palliative Care

Ninewells Hospital 17/04/18 Background Intrathecal Drug Delivery is a method of giving medication directly into the spinal cord Its an option when most other treatment options have failed As the medications are delivered directly into the spinal cord, symptoms can be controlled with much smaller doses than would be required orally

Side effects are reduced It is an unlicensed product Hydromorphone Is a potent opioid with increasing intraspinal off-labelMedications use Commonly to treat cancer and nonUsed malignant pain. Side effects are less common compared to morphine

Clonidine Is an a2 Agonist that enhances the analgesic affect of the opioid. It is often effective for neuropathic pain. Side effects include hypotension and sedation Levobupivicaine /Bupivicaine Is a sodium channel blocker used as an anaesthetic. Side effects include motor weakness and urinary retention The Team Palliative Care Consultant(s)

Pain Consultant(s) Neurosurgeon Palliative Pharmacist Palliative Technician

Aseptic Pharmacist Education and Training Standard Operating Procedure Unlicensed Opioid Intrathecal Injection Must comply with The Safe and Secure Handling of Medicines Policy and The Controlled Drug Policy The Prescription

Prescriber will complete a prescription and request form (Handout 1) Pharmacist verifies this, checking calculations and strengths The Prescription is then given to the pharmacy office for them to get in contact with ITH Pharma with regards to Ordering

Order product from ITH Pharma (company that specialises in the provision of aseptic compounding services for all therapy areas) Manufacturing and delivery is roughly a one week process They request a copy of the prescription Product is labelled for the patient specifically with name and CHI

The cost is around 400 per syringe Storage Product kept in quarantine in dispensary CD vault intrathecal in quarantine The product is entered into the intrathecal register by the palliative technician

The cassette or syringe is pre-labelled The product will be packed and transported separately from treatments for administration by other routes The intrathecal should be collected immediately before the planned administration The package with clearly state for intrathecal use only

Thank You Any Questions Synchromed II Programming 1) At least 20mins after MRI, turn on the NVision and press the pump icon on the screen: 2) Choose Synchromed II 3) Press Interrogate to start communication with the pump 4) Allow full interrogation until telemetry is complete

and select ok 5) Tick Logs from options and press OK 6) Position programming head over pump and press OK 7) Pump status report is displayed with current pump settings. Select X to close 8) Select toolkit icon 9) Select pump logs tab

10) Select Get Logs 11) Event log data screen displays all event history including alarms or PA requests

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