Peri-Articular-Multimodal Drug and Oral Celecoxib in Management of Postoperative Pain of Total Knee Arthroplasty
Condition: Postoperative Pain; Total Knee Arthroplasty
MeSH terms: Pain, Postoperative
Study type: Interventional
Phase: Phase 2

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.
    

Intervention name(s): Multimodal Drug; epinephrine; celecoxib
Intervention type(s): Drug; Drug; Drug
Intervention description(s): The Multimodal Drug group received morphine, epinephrine, and ketorolac (n=48), The epinephrine group (placebo group) (n=49) received 300 mcg epinephrine (1:1000) (DarouPakhsh, Tehran, Iran) peri-articulary,and the celecoxib group(control group)(n=49) recieved 400mg celecoxib orally; The second group received 300 mcg epinephrine (1:1000) (DarouPakhsh, Tehran, Iran) peri-articulary; The third group administered celecoxib (200 mg) orally immediately before the surgery
Other intervention name(s): Case; Placebo; Control
Intervention MeSH terms: Celecoxib; Epinephrine
Allocation: Randomized
Intervention model: Sequential Assignment
Masking: Double (Participant, Investigator)
Primary purpose: Treatment
Keywords: Total knee arthroplasty; Pain; Multimodal analgesia; Range of motion