Peri-Articular-Multimodal Drug and Oral Celecoxib in Management of Postoperative Pain of Total Knee Arthroplasty
- Conditions
- Postoperative PainTotal Knee Arthroplasty
- Interventions
- Registration Number
- NCT05324995
- Lead Sponsor
- Isfahan University of Medical Sciences
- 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.
Recruitment & Eligibility
- Status
- COMPLETED
- Sex
- All
- Target Recruitment
- 146
- Clinical diagnosis of osteoarthritis
- Candidate for primary unilateral TKA
- Body mass index of 20-30 kg/m2
- Unable to follow-up the assessments
- Having more than 20% defects in medical records
Study & Design
- Study Type
- INTERVENTIONAL
- Study Design
- SEQUENTIAL
- Arm && Interventions
Group Intervention Description Multimodal injection Multimodal Drug The first group was treated using a preemptive periarticular injection of multimodal drugs. Therefore, a combination of drugs consisted of 50 mg bupivacaine hydrochloride 0.5% (AstraZeneca, Cenexi, France), 1 ml morphine sulfate 10 mg/ml (DarouPakhsh, Tehran, Iran), 300 mcg epinephrine (1:1000) (DarouPakhsh, Tehran, Iran) and 30 mg ketorolac (Caspian Tamin, Rasht, Iran) diluted by 0.9% sodium chloride solution to make a total 100 ml of injection drug was injected in periarticular area. The injections were done within 15 minutes before the incision in seven areas of the joint as followed: 15 ml in posterolateral soft tissue and lateral femoral periosteum, 15 ml posteromedial soft tissue and medial femoral periosteum, 20 ml inferomedial capsule, 20 ml superomedial capsule, 10 ml lateral capsule, 10 ml medial subcutaneous tissues and 10 ml lateral subcutaneous tissue. epinephrine group (placebo group) epinephrine The second group received 300 mcg epinephrine (1:1000) (DarouPakhsh, Tehran, Iran) peri-articulary, similar to the first group. celecoxib group (control group) celecoxib The third group administered celecoxib (200 mg) orally immediately before the surgery initiation.
- Primary Outcome Measures
Name Time Method Baseline Measurements of Knee Society Score (KSS) At the beginning of the study The Knee Society score is an assessment of the knee that comprises two arms, the functional ability and clinical examination scores, each with a 100-point denominator. One-hundred points are allocated to the functional capacity, including walking distance, stair-climbing ability, and the use of walking aids.
Range of motion (ROM) 6 months after surgery Knee ROM was evaluated using a standard goniometer
Knee Society Score (KSS) 6 months after surgery The Knee Society score is an assessment of the knee that comprises two arms, the functional ability and clinical examination scores, each with a 100-point denominator. One-hundred points are allocated to the functional capacity, including walking distance, stair-climbing ability, and the use of walking aids.
visual analogue scale (VAS) Six weeks after surgery Visual Analogue Scale (VAS) was used to evaluate the patient's postoperative pain intensity with a 0 to 10 rating scoring scale
Baseline range of motion (ROM) At the beginning of the study Knee ROM was evaluated using a standard goniometer
- Secondary Outcome Measures
Name Time Method
Trial Locations
- Locations (1)
Isfahan University of Medical Sciences
🇮🇷Isfahan, Iran, Islamic Republic of