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

NCT05324995 · Status: COMPLETED · Phase: PHASE2 · Type: INTERVENTIONAL · Enrollment: 146

Last updated 2022-04-14

No results posted yet for this study

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.

Conditions

  • Postoperative Pain
  • Total Knee Arthroplasty

Interventions

DRUG

Multimodal Drug

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

DRUG

epinephrine

The second group received 300 mcg epinephrine (1:1000) (DarouPakhsh, Tehran, Iran) peri-articulary

DRUG

celecoxib

The third group administered celecoxib (200 mg) orally immediately before the surgery

Sponsors & Collaborators

  • Isfahan University of Medical Sciences

    lead OTHER

Study Design

Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
DOUBLE
Model
SEQUENTIAL

Eligibility

Min Age
37 Years
Max Age
81 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

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

Countries

  • Iran

Study Locations

More Related Trials

Entities

Drugs

Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT05324995 on ClinicalTrials.gov