Patient Controlled Intrathecal Analgesia With Bupivacaine for Chronic Low Back Pain
CompletedPhase 4NCT02886286
View the official record on ClinicalTrials.gov Recruiting status changes often. Contact the study team listed on ClinicalTrials.gov, and talk to your doctor before joining a study.
This study has no listed site in Canada in this snapshot. It is included as part of the worldwide chronic pain corpus.
Brief summary (from the registry)
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.
Study details
- 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
- Conditions
- Pain, Intractable
- Breakthrough Pain
- Chronic Pain
- Interventions
- Drug: Bupivacaine
- Drug: Opioid
- Sponsor
- University Hospitals Cleveland Medical Center
- Start date
- 2016-05
- Primary completion
- 2017-12
- Sex
- All
- Age range
- from 31 Years to 90 Years
- Results posted
- Yes, on ClinicalTrials.gov
- Countries
- United States
- Total sites listed
- 1
Eligibility criteria
Show eligibility criteria (verbatim from the registry)
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
Source: ClinicalTrials.gov (US National Library of Medicine), snapshot October 2026. Check the registry for current recruiting status. Record: https://clinicaltrials.gov/study/NCT02886286