Preemptive Analgesia Combination of Celecoxib and Pregabalin in THA

Phase 2

• Conditions: Analgetic; Arthroplasty Complications; Pregabalin; Celecoxib
• Interventions: Drug: Repeated dose of celecoxib 200 mg and pregabalin 75 mg; Drug: Single dose of celecoxib 400 mg and pregabalin 150 mg; Drug: Placebo

• Registration Number: NCT05509946
• Lead Sponsor: Indonesia University

Brief 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

Study Timeline

• Status Verified: 2022-08
• Study First Submitted: 2022-08-19
• Study First Submitted QC: 2022-08-19
• Last Update Submitted: 2022-08-21
• Study First Posted: 2022-08-22
• Last Update Posted: 2022-08-24
• Study Start: 2022-10-01
• Primary Completion: 2023-04-01
• Study Completion: 2023-04-30

Recruitment & Eligibility

• Status: UNKNOWN
• Sex: All
• Target Recruitment: 30

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

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
Repeated dose of celecoxib 200 mg and pregabalin 75 mg	Repeated dose of celecoxib 200 mg and pregabalin 75 mg	Repeated dose of celecoxib 200 mg twice a day and pregabalin 75 mg twice a day administered starting from 3 days before surgery
Single dose of celecoxib 400 mg and pregabalin 150 mg	Single dose of celecoxib 400 mg and pregabalin 150 mg	Single dose of celecoxib 400 mg and pregabalin 150 mg administered an hour before surgery
Placebo	Placebo	Placebo

Primary Outcome Measures

Name	Time	Method
Postoperative Pain	After surgery for three days	Acute pain measured in the morning before activity after surgery. Measured by numeric pain rating scale 0 - 10 which lower score means less pain while higher score means more pain
Total consumption of morphine	Three days	Morphine is an opioid analgesic, in this study it was used as an analgesic as well as an objective parameter to assess the effectiveness of celecoxib and pregabalin. Given with a patient control analgesia (PCA) device. Dosage of morphine used