search
Back to results

Patient Controlled Intrathecal Analgesia With Bupivacaine for Chronic Low Back Pain

Primary Purpose

Pain, Intractable, Breakthrough Pain, Chronic Pain

Status
Completed
Phase
Phase 4
Locations
United States
Study Type
Interventional
Intervention
Bupivacaine
Opioid
Sponsored by
University Hospitals Cleveland Medical Center
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Pain, Intractable

Eligibility Criteria

31 Years - 90 Years (Adult, Older Adult)All SexesDoes not accept healthy volunteers

Inclusion Criteria

  • Age more than 30 years implanted with an intrathecal drug delivery device.
  • Intrathecal pump patients on stable dose for the last 3 months.
  • Using on average more than 2 and less than 10 PTM doses per day
  • Intrathecal medication admixture consisting of bupivacaine and another opioid (fentanyl or hydromorphone or morphine)

Exclusion Criteria

  • Using 10 or more PTM bolus doses per day or 2 or less PTM bolus doses per day
  • Pending litigation or worker compensation claim
  • Any recent (less than 3 month) procedures in spine (surgeries) or catheter adjustments.
  • Recent pump dose adjustment within the past 3 months
  • Pumps with medications other than bupivacaine/opioid combination.
  • Pregnant or breast feeding

Sites / Locations

  • University Hospitals Case Medical Center

Arms of the Study

Arm 1

Arm 2

Arm Type

Experimental

Active Comparator

Arm Label

Bupivacaine + Opioid

Opioid

Arm Description

Intrathecal solution has bupivacaine with an opioid (hydromorphone, fentanyl or morphine). Patients will administer PTM bolus of bupivacaine with opioid. The bolus will be administered over 2 minutes and will have a variable frequency depending on patient's need but the number of boluses should be >2 and <10. The bupivacaine dosage would range between 0.4 and 1.5 mg per bolus. The opioid dose will vary depending on the concentration of the opioid in the solution.

Intrathecal solution has only an opioid (hydromorphone, fentanyl or morphine) and no bupivacaine. Patients will administer PTM bolus of opioid without bupivacaine. This opioid bolus dose would be the same as they would have received prior to enrolling in the study (with bupivacaine). The bolus will be administered over 2 minutes and will have a variable frequency depending on patient's need but the number of boluses should be >2 and <10.

Outcomes

Primary Outcome Measures

Change From Baseline in the Numerical Rating Pain Scale (NRS)
Patients will be provided with a diary to record pain scores just before a PTM bolus and the lowest pain score within half an hour after a PTM bolus. Numerical Rating Pain Scale (NRS): scale from 0-10 0 = no pain 10 = worst imaginable pain

Secondary Outcome Measures

Change From Baseline in Oswestry Disability Index (ODI)
Oswestry Disability Index (ODI): calculated as a percentage based on scores from 0-5 in 10 categories (pain intensity, personal care, lifting, walking, sitting, standing, sleeping, sex life, social life, travelling). 0 signifies no pain interference while 5 signifies maximum possible pain interference in the 10 categories. Scores from 0-5 for 10 categories are added and divided by total possible score (50) X 100 to give percentage. Interpretation of percentage scores: 0 - 20% minimal disability 21-40% moderate disability 41-60% severe disability 61-80% crippled 81-100% either bed bound or patient is exaggerating symptoms
Change From Baseline in Patient Global Impression of Change (PGIC)
Patient Global Impression of Change (PGIC): reflects patient's belief about the efficacy of treatment = very much improved = much improved = minimally improved = no change = worse = much worse = very much worse
Change From Baseline in painDETECT
painDETECT is a nine-item questionnaire that consists of seven sensory symptom items for pain that are graded from 0= never to 5= strongly, one temporal item on pain-course pattern graded -1 to +1, and one spatial item on pain radiation graded 0 for no radiation or +2 for radiating pain. A total score that ranges from -1 to 38 can be calculated from the nine items, with higher scores indicating higher levels of pain.
Change From Baseline in Average Weekly Numeric Pain Rating Score (NRS)
Average Weekly Numeric Pain Rating Score (NRS) over the past week Numerical Rating Pain Scale (NRS): scale from 0-10 0 = no pain 10 = worst imaginable pain
Change From Baseline in Treatment Satisfaction
A 5-point qualitative Likert scale was used to report measures of patient satisfaction (i.e., not satisfied at all, not satisfied, somewhat, satisfied, very satisfied). To quantify satisfaction, these responses were transformed to a scale of 0-4, with higher numbers representing greater levels of satisfaction.

Full Information

First Posted
August 18, 2016
Last Updated
February 27, 2022
Sponsor
University Hospitals Cleveland Medical Center
search

1. Study Identification

Unique Protocol Identification Number
NCT02886286
Brief Title
Patient Controlled Intrathecal Analgesia With Bupivacaine for Chronic Low Back Pain
Official Title
Randomized, Double Blind, Cross Over Study Comparing Effectiveness of Traditional Opioids Versus Opioids in Admixture With Bupivacaine Upon Self-administration of Boluses Via a Personal Therapy Manager (PTM) in Intrathecal Pumps
Study Type
Interventional

2. Study Status

Record Verification Date
February 2022
Overall Recruitment Status
Completed
Study Start Date
May 2016 (undefined)
Primary Completion Date
December 2017 (Actual)
Study Completion Date
December 2017 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Principal Investigator
Name of the Sponsor
University Hospitals Cleveland Medical Center

4. Oversight

Data Monitoring Committee
Yes

5. Study Description

Brief Summary
The purpose of this study is to determine whether the local anesthetic bupivacaine delivered intrathecally in small doses via PTM self-administered boluses significantly improves the breakthrough pain and functional status of patients with chronic intractable pain who are managed with an intrathecal drug delivery system.
Detailed Description
Methodology /Technical Approach: Seventeen patients who are already using SynchroMed II pump containing an admixture of bupivacaine and an opioid and using PTM doses will receive Solution A during the first week of the study and will be crossed over to Solution B during the second week of the study. Solution A and Solution B would consist of either the patient's usual intrathecal opioid with bupivacaine at the same concentrations or the usual patient's intrathecal opioid at the same concentration but without bupivacaine. Only the Investigational Pharmacy at University Hospitals Case Medical Center (UHCMC) would be aware of the contents of Solution A and Solution B. Patients and study personnel in the Pain Medicine Division would be blinded to the solution content. The sequence of pump refills will be as follows: Week I: Patients will have the intrathecal pumps refilled with 10 milliliters of a Solution A or B, after removal of residual volume of baseline solution. Week II: IT pump will be filled with 10 ml of Solution A or B (whichever solution subject did not receive Week 1), after removal of residual volume from Week I. Both patients and the evaluating physician will be blinded. In order to accomplish this, only the central compounding (investigational) pharmacy at UHCMC would make two solutions labeled: A or B respectively. Study subjects will be randomized and randomization order will be held at the pharmacy that will supply the medication. Patients will be kept on each solution for one week. Data will be collected daily Primary outcome measures will include 0-10 numerical rating scale (NRS) or Visual Analogue Scale (VAS) both immediately before and within 30 minutes after a PTM bolus. Patients will be provided with a diary to record pain scores just before a PTM bolus and the lowest pain score within half an hour after a PTM bolus. Only 5 recording per day on days 3-7 and 10-14 will be available on the diary-thus patients would record pain scores only before and after the first 5 PTM boluses. Only the scores before and after the first 3 successful PTM boluses would be considered. Successful PTM activations would be determined by review of the patient PTM diary and the internal log from the intrathecal drug delivery system. Each recording on the PTM diary would be time matched to the successful PTM activation code in the internal log. This will obviate any potential mis-administered bolus whereby the patient does not activate the bolus device appropriately. Secondary outcome measures will include average NRS pain scores for the week, functional capacity as evaluated by the Oswestry disability index (ODI) scores, Global Impression of Change and painDETECT. Other relevant data such as number of boluses used and paresthetic sensation post bolus (if felt)/patient guess of blinding arm would be recorded.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Pain, Intractable, Breakthrough Pain, Chronic Pain

7. Study Design

Primary Purpose
Treatment
Study Phase
Phase 4
Interventional Study Model
Crossover Assignment
Masking
ParticipantCare ProviderInvestigatorOutcomes Assessor
Allocation
Randomized
Enrollment
17 (Actual)

8. Arms, Groups, and Interventions

Arm Title
Bupivacaine + Opioid
Arm Type
Experimental
Arm Description
Intrathecal solution has bupivacaine with an opioid (hydromorphone, fentanyl or morphine). Patients will administer PTM bolus of bupivacaine with opioid. The bolus will be administered over 2 minutes and will have a variable frequency depending on patient's need but the number of boluses should be >2 and <10. The bupivacaine dosage would range between 0.4 and 1.5 mg per bolus. The opioid dose will vary depending on the concentration of the opioid in the solution.
Arm Title
Opioid
Arm Type
Active Comparator
Arm Description
Intrathecal solution has only an opioid (hydromorphone, fentanyl or morphine) and no bupivacaine. Patients will administer PTM bolus of opioid without bupivacaine. This opioid bolus dose would be the same as they would have received prior to enrolling in the study (with bupivacaine). The bolus will be administered over 2 minutes and will have a variable frequency depending on patient's need but the number of boluses should be >2 and <10.
Intervention Type
Drug
Intervention Name(s)
Bupivacaine
Intervention Description
Patient-activated intrathecal bolus for incident pain
Intervention Type
Drug
Intervention Name(s)
Opioid
Other Intervention Name(s)
Fentanyl, Hydromorphone, Morphine
Intervention Description
Patient-activated intrathecal bolus for incident pain
Primary Outcome Measure Information:
Title
Change From Baseline in the Numerical Rating Pain Scale (NRS)
Description
Patients will be provided with a diary to record pain scores just before a PTM bolus and the lowest pain score within half an hour after a PTM bolus. Numerical Rating Pain Scale (NRS): scale from 0-10 0 = no pain 10 = worst imaginable pain
Time Frame
Before self-administered bolus using Patient Therapy Manager device (PTM) and within 30 minutes of PTM bolus
Secondary Outcome Measure Information:
Title
Change From Baseline in Oswestry Disability Index (ODI)
Description
Oswestry Disability Index (ODI): calculated as a percentage based on scores from 0-5 in 10 categories (pain intensity, personal care, lifting, walking, sitting, standing, sleeping, sex life, social life, travelling). 0 signifies no pain interference while 5 signifies maximum possible pain interference in the 10 categories. Scores from 0-5 for 10 categories are added and divided by total possible score (50) X 100 to give percentage. Interpretation of percentage scores: 0 - 20% minimal disability 21-40% moderate disability 41-60% severe disability 61-80% crippled 81-100% either bed bound or patient is exaggerating symptoms
Time Frame
Day 0, 7, 14, score at day 7 or day 14 reported
Title
Change From Baseline in Patient Global Impression of Change (PGIC)
Description
Patient Global Impression of Change (PGIC): reflects patient's belief about the efficacy of treatment = very much improved = much improved = minimally improved = no change = worse = much worse = very much worse
Time Frame
Day 0, 7, 14, score at day 7 or day 14 reported
Title
Change From Baseline in painDETECT
Description
painDETECT is a nine-item questionnaire that consists of seven sensory symptom items for pain that are graded from 0= never to 5= strongly, one temporal item on pain-course pattern graded -1 to +1, and one spatial item on pain radiation graded 0 for no radiation or +2 for radiating pain. A total score that ranges from -1 to 38 can be calculated from the nine items, with higher scores indicating higher levels of pain.
Time Frame
Day 0, 7, 14, score at day 7 or day 14 reported
Title
Change From Baseline in Average Weekly Numeric Pain Rating Score (NRS)
Description
Average Weekly Numeric Pain Rating Score (NRS) over the past week Numerical Rating Pain Scale (NRS): scale from 0-10 0 = no pain 10 = worst imaginable pain
Time Frame
Day 0, 7, 14, score at day 7 or day 14 reported
Title
Change From Baseline in Treatment Satisfaction
Description
A 5-point qualitative Likert scale was used to report measures of patient satisfaction (i.e., not satisfied at all, not satisfied, somewhat, satisfied, very satisfied). To quantify satisfaction, these responses were transformed to a scale of 0-4, with higher numbers representing greater levels of satisfaction.
Time Frame
Day 0, 7, 14, score at day 7 or day 14 reported

10. Eligibility

Sex
All
Minimum Age & Unit of Time
31 Years
Maximum Age & Unit of Time
90 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
Inclusion Criteria Age more than 30 years implanted with an intrathecal drug delivery device. Intrathecal pump patients on stable dose for the last 3 months. Using on average more than 2 and less than 10 PTM doses per day Intrathecal medication admixture consisting of bupivacaine and another opioid (fentanyl or hydromorphone or morphine) Exclusion Criteria Using 10 or more PTM bolus doses per day or 2 or less PTM bolus doses per day Pending litigation or worker compensation claim Any recent (less than 3 month) procedures in spine (surgeries) or catheter adjustments. Recent pump dose adjustment within the past 3 months Pumps with medications other than bupivacaine/opioid combination. Pregnant or breast feeding
Facility Information:
Facility Name
University Hospitals Case Medical Center
City
Cleveland
State/Province
Ohio
ZIP/Postal Code
44106
Country
United States

12. IPD Sharing Statement

Learn more about this trial

Patient Controlled Intrathecal Analgesia With Bupivacaine for Chronic Low Back Pain

We'll reach out to this number within 24 hrs