Clinical trial NCT02886286: 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
Overall status: COMPLETED
Phase: PHASE4
Conditions: Pain, Intractable
Breakthrough Pain
Chronic Pain
Lead sponsor: University Hospitals Cleveland Medical Center
Sponsor class: OTHER
First posted: 2016-09-01
Enrollment: 17
Sex: ALL
Minimum age (years): 31
Maximum age (years): 90
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: CROSSOVER
Primary purpose: TREATMENT

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.

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

Primary outcomes:
measure: Change From Baseline in the Numerical Rating Pain Scale (NRS)
timeFrame: Before self-administered bolus using Patient Therapy Manager device (PTM) and within 30 minutes of PTM bolus
Secondary outcomes:
measure: Change From Baseline in Oswestry Disability Index (ODI)
timeFrame: Day 0, 7, 14, score at day 7 or day 14 reported
measure: Change From Baseline in Patient Global Impression of Change (PGIC)
timeFrame: Day 0, 7, 14, score at day 7 or day 14 reported
measure: Change From Baseline in painDETECT
timeFrame: Day 0, 7, 14, score at day 7 or day 14 reported
measure: Change From Baseline in Average Weekly Numeric Pain Rating Score (NRS)
timeFrame: Day 0, 7, 14, score at day 7 or day 14 reported
measure: Change From Baseline in Treatment Satisfaction
timeFrame: Day 0, 7, 14, score at day 7 or day 14 reported
Other outcomes:
Locations:
city: Cleveland
country: United States
facility: University Hospitals Case Medical Center
state: Ohio
Study officials:
References: