CI

At a glance

ClinicalIndex Comparison Record
Phase 3Completed· 98 enrolled
Drug / intervention
Bupivacaine + CBD (clonidine, buprenorphine, dexamethasone) +1 moredrug
Likely dose
Bupivacaine + clonidine, buprenorphine, dexamethasone administered as nerve blocksAI-extracted
Key inclusion· 5
  • Age between 18 and 85 years old
  • Undergoing total knee or hip replacement surgery
  • Fluent in English, decision competent, willing and able to provide written informed consent
  • Able to walk more than 3 meters without an assisting device
Key exclusion· 15
  • Currently participating in another orthopedic, physical therapy, rehab, or anesthesiology interventional clinical trial
  • Significant behavioral risks or refractory major psychiatric disorders
  • Revision surgery on the same extremity
  • ASA Physical Status classification 4 or higher

Standardized by ClinicalIndex from the ClinicalTrials.gov record · verify against the source.

Search/NCT02891798
NCT02891798Phase 3Completed

4-drug Nerve Block Versus Plain Local Anesthetic for Knee and Hip Arthroplasty Analgesia in Veterans

Brian Williams·interventional·Posted Sep 8, 2016·Updated Jan 14, 2022

In Brief

A Phase 3 clinical trial evaluating Bupivacaine + CBD (clonidine, buprenorphine, dexamethasone) and Bupivacaine Only (control arm) for Pain. Completed, enrolled 98 participants across 1 site.

Detailed Summary

After total joint replacement, early hospital discharge to home (with patients capable of continuing a home-based rehabilitation program) is a cost- effective management strategy. This project will use improved local anesthetic nerve block techniques to enhance technical capability and clinical practice by (i) reducing pain and other morbidities during recovery, (ii) improving weight-bearing achievement during in-hospital physical therapy to allow for earlier return home, and (iii) continued rehabilitation as an outpatient at home when feasible (versus in an extended care facility).

Study Details

Study Typeinterventional
Allocation--
Masking--
Primary Purpose--
ConditionsPain
CountriesUnited States

Timeline

Phase 3CompletedFinished
2017201820192020202120222023202420252026
First PostedSep 8, 2016
Enrollment StartOct 1, 2016
Primary CompletionJul 12, 2021
Study CompletionAug 20, 2021
TodayJul 2, 2026
Enrollment to primary: 4.8 yearsPosted 9.8 years ago

Interventions

Bupivacaine + CBD (clonidine, buprenorphine, dexamethasone)drug

Nerve blocks before surgery of L2-L4 and L4-S3 for Knee replacements Nerve blocks before surgery of L2-L4 for hip replacements

Bupivacaine Only (control arm)drug

Nerve blocks before surgery of L2-L4 and L4-S3 for Knee replacements Nerve blocks before surgery of L2-L4 for hip replacements