At a glance
ClinicalIndex Comparison RecordPhase 4Completed· 17 enrolled
Drug / intervention
Bupivacaine +1 moredrug
Likely dose
Not stated in record
Structured eligibility isn't available for this trial yet — see the full criteria in the Eligibility tab below.
Standardized by ClinicalIndex from the ClinicalTrials.gov record · verify against the source.
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
University Hospitals Cleveland Medical Center·interventional·Posted Sep 1, 2016·Updated Mar 24, 2022
In Brief
A Phase 4 clinical trial evaluating Bupivacaine and Opioid for Pain, Intractable and 2 related conditions. Completed, enrolled 17 participants across 1 site.
Detailed 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.
Study Details
Study Typeinterventional
Allocation--
Masking--
Primary Purpose--
ConditionsPain, Intractable, Breakthrough Pain, Chronic Pain
CountriesUnited States
Collaborators--
Timeline
Phase 4CompletedFinished
2017201820192020202120222023202420252026
Enrollment StartMay 2016
First PostedSep 2016
Primary CompletionDec 2017
TodayJul 2026
First PostedSep 1, 2016
Enrollment StartMay 1, 2016
Primary CompletionDec 1, 2017
TodayJul 2, 2026
Enrollment to primary: 1.6 yearsPosted 9.8 years ago
Interventions
Bupivacainedrug
Patient-activated intrathecal bolus for incident pain
Opioiddrug
Patient-activated intrathecal bolus for incident pain