drugset / Trial / NCT02891798

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

NCT02891798 ↗

Phase 3 Completed 98 enrolled Brian Williams University of Pittsburgh · collab
RandomizedParallel-groupQuadruple-blindTreatment

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).

Timeline

Start
2016-10
Primary completion
2021-07-12
Completion
2021-08-20

Outcome

Met primary endpoint

paper the SF-MPQ-2 total score for the BPV-BCD group demonstrated greater pain reduction than that of the plain BPV group PMID 34730810 ↗

registry analysis (superiority test); Bupivacaine + BCD (Buprenorphine, Clonidine, Dexamethasone) vs Bupivacaine Only (Control Arm); p = 0.003; t-test, 2 sided NCT02891798 ↗

registry analysis (superiority test); Bupivacaine + BCD (Buprenorphine, Clonidine, Dexamethasone) vs Bupivacaine Only (Control Arm); p = 0.001; t-test, 2 sided NCT02891798 ↗

registry analysis (superiority test); Bupivacaine + BCD (Buprenorphine, Clonidine, Dexamethasone) vs Bupivacaine Only (Control Arm); p = 0.038; t-test, 2 sided NCT02891798 ↗

Drugs

EvaluationDrugModalityDoseRoute
Subject Buprenorphine Other / unclassified — Other
Subject Clonidine Other / unclassified — Other
Subject Dexamethasone Small molecule — Other
Background Bupivacaine Other / unclassified — Other

Indications

No indication recorded.