Preemptive Analgesia Combination of Celecoxib and Pregabalin in THA

Study Overview
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Brief Summary
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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
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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. Study location This study will be conducted at the Cipto Mangunkusumo Hospital, Jakarta, Indonesia. Study time This study will be conducted in October 2022 - April 2023 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. 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 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

Official Title
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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)

Conditions
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Arthroplasty Complications, Analgetic, Celecoxib, Pregabalin

Intervention / Treatment
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* Drug: Single dose of celecoxib 400 mg and pregabalin 150 mg
* Drug: Repeated dose of celecoxib 200 mg and pregabalin 75 mg
* Drug: Placebo


Participation Criteria
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Eligibility Criteria
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Inclusion Criteria: Patients >18 years old Patients who come to the RSCM Orthopedic Polyclinic Patients undergoing THA operasi surgery Patients with Primary and Secondary Pelvic Osteoarthritis The patient is taking anti-pain and anti-inflammatory drugs regularly 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

Ages Eligible for Study
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Minimum Age: 18 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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Accepts Healthy Volunteers

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Treatment
Allocation: Randomized
Intervention Model: Parallel Assignment
Interventional Model Description: There are 3 separate groups defined by randomization: single dose of combined celecoxib 400 mg and pregabalin 150 mg an hour before surgery repeated dose of combined celexocib 200 mg twice a day and pregabalin 75 mg twice a day, administered 3 days before surgery placebo administered an hour before surgery
Masking: Triple


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: Single dose of celecoxib 400 mg and pregabalin 150 mg<br>Single dose of celecoxib 400 mg and pregabalin 150 mg administered an hour before surgery | Drug: Single dose of celecoxib 400 mg and pregabalin 150 mg<br>* Single dose of celecoxib 400 mg and pregabalin 150 mg<br>|
| Active Comparator: Repeated dose of celecoxib 200 mg and pregabalin 75 mg<br>Repeated dose of celecoxib 200 mg twice a day and pregabalin 75 mg twice a day administered starting from 3 days before surgery | Drug: Repeated dose of celecoxib 200 mg and pregabalin 75 mg<br>* Repeated dose of celecoxib 200 mg and pregabalin 75 mg started 3 days before surgery<br>|
| Placebo Comparator: Placebo<br>Placebo | Drug: Placebo<br>* Placebo<br>|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Postoperative Pain | 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 | After surgery for three days | 
| Total consumption of morphine | 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 | Three days | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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total hip arthroplasty, celecoxib, pregabalin, preemptive analgetic