1. Overview of Spinal Analgesia
Prof Lesley Colvin
Consultant/ Hon Professor in Anaesthesia & Pain Medicine

2. 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)

3. Peripheral & Central Nervous System response
Cancer Pain
Bone metastases
Tumour infiltration
Cancer treatment
Nerve damage
Inflammation
Peripheral & Central Nervous System response

4. Drug related side effects
Cancer Pain:
Clinical Challenges
Pain assessment
Drug related side effects
Neuropathic pain
Breakthrough pain

5. Does use of a bedside assessment tool improve pain control?
Improving basic pain assessment Edinburgh Pain Assessment and management Tool (EPAT©)
Does use of a bedside assessment tool improve pain control?
Step 2
Prompts
Step 1 Warning Flags
EPAT
Education Programme

6. 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:  /JCO

7. Management Options Adjuvants WHO ladder Escalation/rotation opioids
Invasive therapy
Coeliac plexus block
Spinal analgesia
Adjuvants

8. Assessment of cancer pain
Opioid/ adjuvant titration
Side effects
Efficacy
Spinal analgesia
Reassessment

9. Epidural/ intrathecal analgesia
Central neural block
Epidural/ intrathecal analgesia
Spinous process
Spinal cord
Dorsal root
Ventral root
Vertebral body
Dura mater
Arachnoid mater

10. Treatment algorithm for intrathecal analgesia patient selection
Algorithm of patient‐selection characteristics. Green arrows indicate affirmation or positive response, red arrows signify negative response. Dashed arrows signify similarity amongst groups. Cancer pain is tiered to three categories (see Table ).
IF THIS IMAGE HAS BEEN PROVIDED BY OR IS OWNED BY A THIRD PARTY, AS INDICATED IN THE CAPTION LINE, THEN FURTHER PERMISSION MAY BE NEEDED BEFORE ANY FURTHER USE. PLEASE CONTACT WILEY'S PERMISSIONS DEPARTMENT ON OR USE THE RIGHTSLINK SERVICE BY CLICKING ON THE 'REQUEST PERMISSIONS' LINK ACCOMPANYING THIS ARTICLE. WILEY OR AUTHOR OWNED IMAGES MAY BE USED FOR NON-COMMERCIAL PURPOSES, SUBJECT TO PROPER CITATION OF THE ARTICLE, AUTHOR, AND PUBLISHER.
The Polyanalgesic Consensus Conference (PACC): Recommendations on Intrathecal Drug Infusion Systems Best Practices and Guidelines, Neuromodulation 20(2), : 2017)

11. Treatment algorithm for intrathecal drug delivery for cancer pain
Pain care algorithm for cancer‐related pain. DRG, dorsal root ganglion; HF10, high frequency stimulation; PNfS, peripheral nerve field stimulation; PNS, peripheral nerve stimulation; SCS, spinal cord stimulation. Green arrows indicate affirmation or positive response; red arrows signify negative response.
IF THIS IMAGE HAS BEEN PROVIDED BY OR IS OWNED BY A THIRD PARTY, AS INDICATED IN THE CAPTION LINE, THEN FURTHER PERMISSION MAY BE NEEDED BEFORE ANY FURTHER USE. PLEASE CONTACT WILEY'S PERMISSIONS DEPARTMENT ON OR USE THE RIGHTSLINK SERVICE BY CLICKING ON THE 'REQUEST PERMISSIONS' LINK ACCOMPANYING THIS ARTICLE. WILEY OR AUTHOR OWNED IMAGES MAY BE USED FOR NON-COMMERCIAL PURPOSES, SUBJECT TO PROPER CITATION OF THE ARTICLE, AUTHOR, AND PUBLISHER.

12. 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

13. 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

14. 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

15. Potential complications
Procedural
CSF leak – dural puncture
Infection
Haematoma
Catheter factors
Placement
Movement
Block or fracture
Infection (2-8%)
Pharmacological factors
Acute tolerance
Withdrawal
Toxicity
Urinary retention
Pruritis

16. 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

17. 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

18. Patient care – 1st 24 hrs Leave iv access in situ
Bed rest if dural puncture
Potential problems
Respiratory depression
Infection
Urinary retention
Haematoma
Disconnection
Solutions
Hrly Resp rate; stop long acting opioids; Naloxone available
?Prophylactic antibiotics
catheter
Signs of cord compression
Cover with sterile swab, replace filter and line

19. 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

20. 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: , 2002
N=200 patients, 4 weeks: IDD
mean VAS pain score % 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%)

21. Education and evaluation
Formal training
Formal assessment – intrathecal register
Approved documentation and systems in place
Consider central registry/ database

23. Questions?

24. Patient Mrs B 43-yr-old woman
Presented with tiredness and epigastric pain
Investigations
MRI: pancreatic tumour

25. Mrs B: Oncological Treatment
Interventions included
ERCP/Stent
Hepaticojejunostomy
Tumour not resectable
2nd opinion elsewhere
Chemotherapy

26. Clinical Course Admitted to hospice for symptom control
Severe pain, low mood
Diamorphine subcut. 200mg/24hrs + prn
Request for pain intervention (spouse)

27. Options? WHO ladder Escalation/rotation opioids Invasive therapy
Coeliac plexus block
Spinal catheter

28. What happened? Pain assessment: Tunnelled epidural catheter
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)

29. 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

30. 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..?

31. Prison Healthcare Jillian Galloway Dawn Wigley David Morrison
Clair Petrie

32. Prison Healthcare Jillian Galloway Dawn Wigley David Morrison
Clair Petrie

33. 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

34. Case Work Addictions Team Visiting Podiatrist Visiting Dentist
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 GP
Primary Care Nurses
Pharmacy Team
Public Health Nurse
Mental Health Team
Substance Misuse Team
Case Work Addictions Team
Visiting Podiatrist
Visiting Dentist
Visiting Optician
Assess All New Prison Admissions
SPS Talk to Me Responsibilities
Medicines Administration
Morning approx 260 patients (CDs and detox)
Evening approx 61 patients (CDs, detox, acutes)
Emergency Response
Attend all Incidents of Prisoner Restraint

36. 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

37. 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

38. How do we Care for Palliative Patients in a Custodial Environment?
Aim to provide pain and symptom relief
Physical
Social
Psychological
Spiritual Needs
Total Pain
Palliative Care Pathway in place within PHC to provide care for patients with palliative care needs

39. What are our challenges in delivering palliative care within custodial environment?
Out Reach Support
Nurse Education
Symptom Management
Challenges
Officer Confidence re dying patient
Access to appropriate services within the SPS regime
Communication between NHS and SPS
Complex Population

40. Options
Care for them in custodial environment they are in
Compassionate release
Transfer to hospital or hospice

41. 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 it’s 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.

42. Synchromed II programmable implantable drug pump
Medtronic Neuromodulation

43. Learning Objectives Describe the N’Vision® Clinician Programmer
Describe the Synchromed II programming strategy
Demonstrate programmer functions
Exercises
Practice using clinician programmer functions

44. 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 Oct;97(4):803-10

45. 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 preservative-free ziconotide sterile solution for the management of severe chronic pain
Medtronic Synchromed II Infusion System: Information for Prescribers.

46. Intrathecal Therapy – In reality….
Multiple-drug combinations for pain are common
Baclofen is used in multiple dilutions
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 Andrés 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 Sep-Oct;15(5):436-64; discussion doi: /j x. Epub 2012 Jul 2.

47. Synchromed II Overview
System Components:
Programmable pump
20 and 40ml reservoirs
Catheter
One or two piece
Physician Programmer

48. The Pump Catheter Access Port (CAP) 2 D barcode (tracking)
Test hole (used to test top shield weld integrity)
Refill Port
Suture Loops
© Medtronic Inc Version 1.0

49. Inside Synchromed II… Internal tubing Peristaltic pump Motor Battery
Refill Port
Hybrid
Reservoir

50. Ascenda Catheter Design: Summary of Benefits
Polyurethane Outer Layer
Resistance to leaks and breaks
Silicone Inner Layer
Drug compatible
PET stands for polyester per design engineer Amy Gjoraas
Thermoplastic PET Braid
Six times stronger than our previous silicone catheters
Offers improved resistance to kinking and occlusions

51. 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:
Longevity up to 7 years at 0.9 ml/day
Two reservoir sizes:
20 and 40 ml
Thin profile with contoured shape for comfort:
Width 20 vs. 40 ml pump: 19.5 mm vs. 26 mm
Contains alarm to indicate need for refill or pump replacement
Abbreviations
ITB = intrathecal baclofen
CAP = catheter access port
CSF = cerebrospinal fluid

52. Implantable components How SynchroMed® II infusion pump works
Bellows design allows reservoir to expand/contract according to drug volume
At normal body temperatures:
Pressurized gas in space below reservoir expands and exerts constant pressure on reservoir
Drug advances into pump tubing
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
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
Abbreviations
ITB = intrathecal baclofen
CAP = catheter access port
CSF = cerebrospinal fluid

53. Implantable components Catheter
Thin, elastic and flexible tube
Delivers baclofen from pump to intrathecal space
Made of durable radiopaque silicone rubber
Trimmable at pump end of placed catheter
Sutureless pump connector
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
Abbreviations
ITB = intrathecal baclofen
CAP = catheter access port
CSF = cerebrospinal fluid

54. Synchromed II – in detail (2)
Programming options
Simple continuous, flexible dosing, patient activated bolus, minimum infusion rate
Pump data log
Patient demographics, drug details, catheter information, time stamped event log
MRI Compatibility
Up to 3 Tesla
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)

55. Programming options Simple Continuous mode Single bolus - continuous
Details of modes and boluses covered in the SynchroMed II and SynchroMed EL programming modules.
Flex mode

56. External component N’Vision® 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
N’Vision offers single programming platform for all of Medtronic’s implantable drug delivery and neurostimulation devices
Patient therapy manager (PTM) also available with SynchroMed II
However, although CE mark for PTM is broad and covers ITB Therapy, actual clinical experience is low
PTM for ITB currently not recommended due to lack of substantial clinical data or practical experience

57. N’Vision® Programmer
N’Vision clinician programmer communicates with pump via telemetry
Radio-frequency (RF) communication
SynchroMed® EL pump requires Model 8529 magnet
Attaches to programming head

58. N’Vision® 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

59. Programming Features SynchroMed® II Pump SynchroMed® EL 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
Note: Telemetry takes seconds because of the amount of information transmitted
Patient ID (3 characters)
Pump model number
Drug Information
Name (5 characters)

60. Programming Features
Alarms—Pump sounds an alarm when certain events occur:
SynchroMed II® Pump
SynchroMed® EL Pump
Critical alarm—3-second, 2-tone
Empty reservoir
End of Service (EOS)
Motor stall
Stopped pump exceeds 48 hours
Critical pump memory error
Non-critical alarm—1-second, single-tone
Low reservoir volume reached
Elective Replacement Indicator (ERI)
Non-critical pump memory error
1-tone alarm
Low battery
2-tone alarm
Pump memory error

61. Calibration Constant
Number of electrical pulses required for specific pump to dispense one mcL (µL) of fluid
Specific value for each pump determined during manufacturing
Displayed on Pump Status screen of N’Vision® 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

62. Prepare for Programming Session
Ensure software application card is inserted
Turn the programmer on
Check programmer battery status
Install batteries if needed
Select the Pump Application button
To turn the programmer on or off: Slide and momentarily hold the POWER key on the side of the programmer.

63. Prepare for Programming Session
Select Synchromed II demo
Select Interrogate

64. Overview Screen This screen shows: Minimise screen using small cross
Pump in shelf state (for a new pump), serial number, model number and calibration constant.
Minimise screen using small cross

65. Questions?

66. Intrathecal Drug Delivery
By Jennifer Gray
Specialist Clinical Pharmacist
Neurosurgery, Pain and Palliative Care
Ninewells Hospital
17/04/18

67. Background
Intrathecal Drug Delivery is a method of giving medication directly into the spinal cord
It’s 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
As intrathecal bipasses the path that oral medication takes through the body
Roughly 1/300 the amount of oral medication reqd
Medications are released slowly over a period of time

68. Medications Commonly Used
Hydromorphone – Is a potent opioid with increasing intraspinal “off-label” use to treat cancer and non-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
Medications Commonly Used
Commonly used for palliative patients
May also have heard of baclofen pumps

69. The Team Palliative Care Consultant(s) Pain Consultant(s) Neurosurgeon
Palliative Pharmacist
Palliative Technician
Aseptic Pharmacist
Who is involved in the process

70. 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”

71. 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 formulation and delivery date
NEED TO DECIDE IF THE PATIENT IS AN APPROPRIATE CANDIDIATE

73. 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
Monday – Friday Service (no orders to ITH Pharma out with this time)

74. 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”
Expiry is a month from ITH Pharma manufacturer , however the pain consultant extends the time
Technician will alos release the product along with a member of the aseptic unit who visualises the product for contamination/ particles

75. Thank You Any Questions

76. Synchromed II Programming

77. 1) At least 20mins after MRI, turn on the N’Vision and press the ‘pump’ icon on the screen:
2) Choose ‘Synchromed II’
3) Press ‘Interrogate’ to start communication with the pump

78. 6) Position programming head over pump and press ‘OK’
4) Allow full interrogation until telemetry is complete and select ‘ok’
5) Tick ‘Logs’ from options and press ‘OK’

79. 7) Pump status report is displayed with current pump settings
7) Pump status report is displayed with current pump settings. Select ‘X’ to close
8) Select ‘toolki’t icon
9) Select ‘pump logs ‘ tab

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