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

Phases

Phase 2Phase 3

Study type

Interventional

Source

ClinicalTrials.gov

Registry ID

NCT05509946

Enrollment

Registered

2022-08-22

Start date

2022-10-01

Completion date

2023-04-30

Last updated

2022-08-24

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Analgetic, Arthroplasty Complications, Celecoxib, Pregabalin

Keywords

total hip arthroplasty, celecoxib, pregabalin, preemptive analgetic

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

Interventions

DRUGSingle dose of celecoxib 400 mg and pregabalin 150 mg

Single dose of celecoxib 400 mg and pregabalin 150 mg

DRUGRepeated dose of celecoxib 200 mg and pregabalin 75 mg

Repeated dose of celecoxib 200 mg and pregabalin 75 mg started 3 days before surgery

DRUGPlacebo

Placebo

Study design

Allocation

RANDOMIZED

Intervention model

PARALLEL

Primary purpose

TREATMENT

Masking

TRIPLE (Subject, Caregiver, Investigator)

Masking description

Randomization performed by simple random sampling, the result is latern given to investigator in an envelope containing codes made by third party outside the research. Investigator and the patient do not know the allocation code

Intervention model description

There are 3 separate groups defined by randomization: 1. single dose of combined celecoxib 400 mg and pregabalin 150 mg an hour before surgery 2. repeated dose of combined celexocib 200 mg twice a day and pregabalin 75 mg twice a day, administered 3 days before surgery 3. placebo administered an hour before surgery

Eligibility

Sex/Gender

ALL

Age

18 Years to No maximum

Healthy volunteers

Yes

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

Design outcomes

Primary

Measure	Time frame	Description
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

Contacts

Primary ContactKemas MA Novriandi, MD

Azkanovriandi1991@gmail.com+628194830011

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Feb 4, 2026