Clinical trial NCT05324995: Peri-Articular-Multimodal Drug and Oral Celecoxib in Management of Postoperative Pain of Total Knee Arthroplasty
Official title: Comparing Pre-emptive Injection of Peri-Articular-Multimodal Drug With Oral Celecoxib for Postoperative Pain Management in Total Knee Arthroplasty: A Randomized Clinical Trial
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE2
Conditions: Postoperative Pain
Total Knee Arthroplasty
Keywords: Total knee arthroplasty
Pain
Multimodal analgesia
Range of motion
Lead sponsor: Isfahan University of Medical Sciences
Sponsor class: OTHER
First posted: 2022-04-13
Enrollment: 146
Sex: ALL
Minimum age (years): 37
Maximum age (years): 81
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: SEQUENTIAL
Primary purpose: TREATMENT

Brief 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.

Detailed description: This randomized clinical trial conducted on 146 patients undergone TKA in orthopedic hospitals affiliated at Isfahan University of Medical Science (IUMS) in 2021.

The presence of osteoarthritis, making the patients candidate for primary unilateral total knee arthroplasty (TKA), and body mass index of 20-30 kg/m2 were determined as inclusion criteria.

The Regional Bioethics Committee of IUMS approved the study protocol. This study was designed as a census study; therefore, all the patients who met the criteria for participation in this study were recruited. Participants were randomly divided into three groups using Random Allocation software, so each patient was provided with a specific number from 1-to-146 by the software and allocated to one of the groups.

The investigator who performed the baseline and follow-up assessments and the patients were unaware of the study group; as the investigator was absent at the time of the surgery and all the patients administered a pill prior to the surgical procedure (one group was treated with celecoxib and the other two ones administered placebo similar in shape and color with celecoxib).

The 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.

Eligibility 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

Primary outcomes:
measure: Baseline Measurements of Knee Society Score (KSS)
timeFrame: At the beginning of the study
measure: Baseline range of motion (ROM)
timeFrame: At the beginning of the study
measure: visual analogue scale (VAS)
timeFrame: 24 hours after the surgical procedure
measure: Range of motion (ROM)
timeFrame: 6 months after surgery
measure: Knee Society Score (KSS)
timeFrame: 6 months after surgery
measure: visual analogue scale (VAS)
timeFrame: 48 hours after the surgical procedure
measure: visual analogue scale (VAS)
timeFrame: Six weeks after surgery
Secondary outcomes:
Other outcomes:
Locations:
city: Isfahan
country: Iran, Islamic Republic of
facility: Isfahan University of Medical Sciences
Study officials:
References: