Preemptive Analgesia Combination of Celecoxib and Pregabalin in THA

University of Indonesia (UI)

Status and phase: Not yet enrolling; Phase 3; Phase 2

Conditions: Celecoxib; Arthroplasty Complications; Analgetic; Pregabalin

Treatments: Drug: Placebo; Drug: Single dose of celecoxib 400 mg and pregabalin 150 mg; Drug: Repeated dose of celecoxib 200 mg and pregabalin 75 mg

Study type: Interventional

Funder types: Other

Identifiers

NCT05509946

ID2564

Details and patient eligibility

About

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.

Full 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

Enrollment: 30 estimated patients

Sex: All

Ages: 18+ years old

Volunteers: Accepts Healthy Volunteers

Inclusion criteria

1. Patients >18 years old
2. Patients who come to the RSCM Orthopedic Polyclinic
3. Patients undergoing THA operasi surgery
4. Patients with Primary and Secondary Pelvic Osteoarthritis
5. The patient is taking anti-pain and anti-inflammatory drugs regularly

Exclusion criteria

1. Patients with mental disorders
2. Patients with a history of renal impairment
3. Pelvic arthritis patients due to rheumatoid arthritis or infection
4. Patients with diabetes and obesity
5. Allergy to non-steroidal inflammatory drugs
6. Asthma history
7. Coagulation disorders

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: Triple Blind

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30 participants in 3 patient groups, including a placebo group

Single dose of celecoxib 400 mg and pregabalin 150 mg

Experimental group

Description:

Single dose of celecoxib 400 mg and pregabalin 150 mg administered an hour before surgery

Treatment:

Drug: Single dose of celecoxib 400 mg and pregabalin 150 mg

Repeated dose of celecoxib 200 mg and pregabalin 75 mg

Active Comparator group

Description:

Repeated dose of celecoxib 200 mg twice a day and pregabalin 75 mg twice a day administered starting from 3 days before surgery

Treatment:

Drug: Repeated dose of celecoxib 200 mg and pregabalin 75 mg

Placebo

Placebo Comparator group

Description:

Placebo

Treatment:

Drug: Placebo