drugset / Trial / NCT05324995

Peri-Articular-Multimodal Drug and Oral Celecoxib in Management of Postoperative Pain of Total Knee Arthroplasty

NCT05324995

Phase 2 Completed 146 enrolled Isfahan University of Medical Sciences
RandomizedSequentialDouble-blindTreatment

Summary

This study is a randomized-clinical-trial on 146 patients candidate for total knee arthroplasty (TKA) who were randomly allocated to three treatment groups, including 1) a cocktail consisting of bupivacaine, morphine, epinephrine, and ketorolac (n=48), 2) only epinephrine (placebo group) (n=49), and 3) 400mg celecoxib orally (control group) (n=49) using Random Allocation software. The injections and oral therapy were performed within 15 minutes before the surgical procedure. The study's primary outcome was the Knee Society Score (KSS) calculated at baseline, within six weeks and six months postoperatively. Range of motion (ROM) and Visual Analogue Scale (VAS) to assess pain intensity as the other primary outcomes were evaluated before the procedure, within 24 hours, 48 hours, and six weeks postoperatively.

Timeline

Start
2021-01-01
Primary completion
2022-02-01
Completion
2022-03-01

Drugs

EvaluationDrugModalityDoseRoute
Subject Bupivacaine Other / unclassified 50 mg Other
Subject Celecoxib Other / unclassified 200 mg Oral
Background Epinephrine Other / unclassified 300 ug Other
Subject Ketorolac Other / unclassified 30 mg Other
Subject Morphine Other / unclassified 10 mg Other
Background Epinephrine Other / unclassified 300 ug Other

Indications

No indication recorded.