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Patient Controlled Intrathecal Analgesia With Bupivacaine for Chronic Low Back Pain

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
 
ClinicalTrials.gov Identifier: NCT02886286
Recruitment Status : Completed
First Posted : September 1, 2016
Last Update Posted : June 14, 2018
Sponsor:
Information provided by (Responsible Party):
Salim M Hayek, University Hospitals Cleveland Medical Center

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.

Condition or disease Intervention/treatment Phase
Pain, Intractable Breakthrough Pain Chronic Pain Drug: Bupivacaine Drug: Opioid Phase 4

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.

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Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 17 participants
Allocation: Randomized
Intervention Model: Crossover Assignment
Masking: Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
Primary Purpose: Treatment
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 Start Date : May 2016
Actual Primary Completion Date : December 2017
Actual Study Completion Date : December 2017


Arm Intervention/treatment
Experimental: Bupivacaine + Opioid
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.
Drug: Bupivacaine
Patient-activated intrathecal bolus for incident pain

Drug: Opioid
Patient-activated intrathecal bolus for incident pain
Other Names:
  • Fentanyl
  • Hydromorphone
  • Morphine

Active Comparator: Opioid
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.
Drug: Opioid
Patient-activated intrathecal bolus for incident pain
Other Names:
  • Fentanyl
  • Hydromorphone
  • Morphine




Primary Outcome Measures :
  1. Change in the numerical rating pain scale [ Time Frame: before self-administered bolus using Patient Therapy Manager device (PTM) and within 30 minutes of 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.


Secondary Outcome Measures :
  1. Oswestry Disability Index [ Time Frame: Day 1, 7, 14 ]
    Questionnaire

  2. Global Impression of Change [ Time Frame: Day 1, 7, 14 ]
    Questionnaire

  3. painDETECT [ Time Frame: Day 1, 7, 14 ]
    Questionnaire

  4. Average Weekly Pain Score (NRS) [ Time Frame: Day 1, 7, 14 ]
    Average NRS pain score over the past week

  5. Treatment Satisfaction [ Time Frame: Day 1, 7, 14 ]
    categorical: positive or negative



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Ages Eligible for Study:   31 Years to 90 Years   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
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

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT02886286


Locations
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United States, Ohio
University Hospitals Case Medical Center
Cleveland, Ohio, United States, 44106
Sponsors and Collaborators
University Hospitals Cleveland Medical Center
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Responsible Party: Salim M Hayek, MD, PhD, Chief, Division of Pain Medicine, University Hospitals Cleveland Medical Center
ClinicalTrials.gov Identifier: NCT02886286    
Other Study ID Numbers: 2-16-24
First Posted: September 1, 2016    Key Record Dates
Last Update Posted: June 14, 2018
Last Verified: June 2018
Additional relevant MeSH terms:
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Chronic Pain
Breakthrough Pain
Pain, Intractable
Pain
Neurologic Manifestations
Signs and Symptoms
Fentanyl
Morphine
Hydromorphone
Bupivacaine
Anesthetics, Local
Anesthetics
Central Nervous System Depressants
Physiological Effects of Drugs
Sensory System Agents
Peripheral Nervous System Agents
Analgesics, Opioid
Narcotics
Analgesics
Adjuvants, Anesthesia
Anesthetics, Intravenous
Anesthetics, General