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

• Status: Completed
• Trial end date: 2022-03-01
• Target enrollment: 0
• Participant gender: All

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.

• Phase: Phase 2
• Accepts Healthy Volunteers?: No

Details

• Lead Sponsor: Isfahan University of Medical Sciences
• Treatments: Celecoxib; Epinephrine

Criteria

Inclusion Criteria:

• Clinical diagnosis of osteoarthritis

• Candidate for primary unilateral TKA

• Body mass index of 20-30 kg/m2

Exclusion Criteria:

• Unable to follow-up the assessments

• Having more than 20% defects in medical records