NCT05509946

Preemptive Analgesia Combination of Celecoxib and Pregabalin in THA

Preemptive Analgesia Combination of Celecoxib and Pregabalin in Total Hip Arthroplasty: Comparison of the Effects of Single Dose and Repeated Doses (Double-Blind Randomized Clinical Trial)

• Status: Unknown
• Phase: Phase 2 / Phase 3
• Study type: Interventional
• Enrollment: 30 (estimated)
• Sponsor: Indonesia University · Academic / Other
• Sex: All
• Age: 18 Years
• Healthy volunteers: Accepted

Summary

This is a double-blinded randomized controlled trial aims to evaluate the effect of preemptive analgetic combination of celecoxib and pregabalin to acute pain after total hip arthroplasty. This study will be conducted in Cipto Mangunkusumo Hospital, Jakarta, Indonesia, from October 2022 to April 2023. The subject of this study is adult patient who will be performed total hip arthroplasty.

Detailed description

1. Research design This is a double-blind, randomized clinical trial which aimed to evaluate the effect of preemptive analgesia combined with Celecoxib and Pregabalin on acute post-THA pain. 2. Study location This study will be conducted at the Cipto Mangunkusumo Hospital, Jakarta, Indonesia. 3. Study time This study will be conducted in October 2022 - April 2023 4. Population and sample The target population of this study is adult patients undergoing THA surgery. The randomization technique used in this study is a simple randomization technique. Researchers randomly determine the allocation of samples without looking at subjects' status in the population. 5. Inclusion criteria * Patients \>18 years old * Patients who come to the RSCM Orthopedic Polyclinic * Patients undergoing THA surgery * Patients with Primary and Secondary Pelvic Osteoarthritis * The patient is taking anti-pain and anti-inflammatory drugs regularly 6. Exclusion criteria * Patients with mental disorders * Patients with a history of renal impairment * Pelvic arthritis patients due to rheumatoid arthritis or infection * Patients with diabetes and obesity * Allergy to non-steroidal inflammatory drugs * Asthma history * Coagulation disorders * Patients in the study procedure experienced an incident of severe pain that required another analgesic regimen * History of hypersensitivity to NSAIDs or sulfonamides

Conditions

• Arthroplasty Complications
• Analgetic
• Celecoxib
• Pregabalin

Interventions

Type	Name	Description
DRUG	Single dose of celecoxib 400 mg and pregabalin 150 mg	Single dose of celecoxib 400 mg and pregabalin 150 mg
DRUG	Repeated dose of celecoxib 200 mg and pregabalin 75 mg	Repeated dose of celecoxib 200 mg and pregabalin 75 mg started 3 days before surgery
DRUG	Placebo	Placebo

Timeline

• Start date: 2022-10-01
• Primary completion: 2023-04-01
• Completion: 2023-04-30
• First posted: 2022-08-22
• Last updated: 2022-08-24