Patient Controlled Intrathecal Analgesia With Bupivacaine for Chronic Low Back Pain
Condition: Pain, Intractable; Breakthrough Pain; Chronic Pain
MeSH terms: Chronic Pain; Breakthrough Pain; Pain, Intractable
Study type: Interventional
Phase: Phase 4

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.
    

Intervention name(s): Bupivacaine; Opioid
Intervention type(s): Drug; Drug
Intervention description(s): Patient-activated intrathecal bolus for incident pain; Patient-activated intrathecal bolus for incident pain
Other intervention name(s): Fentanyl; Hydromorphone; Morphine
Intervention MeSH terms: Fentanyl; Morphine; Hydromorphone; Bupivacaine
Allocation: Randomized
Intervention model: Crossover Assignment
Masking: Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
Primary purpose: Treatment