drugset
drugset / Trial / NCT02886286

Patient Controlled Intrathecal Analgesia With Bupivacaine for Chronic Low Back Pain

NCT02886286 ↗

Phase 4 Completed 17 enrolled University Hospitals Cleveland Medical Center
RandomizedCrossoverQuadruple-blindTreatment

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.

Timeline

Start
2016-05
Primary completion
2017-12
Completion
2017-12

Drugs

EvaluationDrugModalityDoseRoute
Subject Bupivacaine Other / unclassified 0.4 mg Intrathecal
Subject Bupivacaine Other / unclassified 1.5 mg Intrathecal
Background Fentanyl Other / unclassified — Intrathecal
Background Hydromorphone Other / unclassified — Intrathecal
Background Morphine Other / unclassified — Intrathecal

Indications

chronic pain syndrome