Preemptive Analgesia Combination of Celecoxib and Pregabalin in THA

August 21, 2022 updated by: Kemas Muhammad Azka Novriandi, Indonesia University

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)

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.

Study Overview

Status

Not yet recruiting

Conditions

Intervention / Treatment

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 Type

Interventional

Enrollment (Anticipated)

30

Phase

  • Phase 2
  • Phase 3

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Contact

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

14 years and older (Adult, Older Adult)

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Description

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 Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Treatment
  • Allocation: Randomized
  • Interventional Model: Parallel Assignment
  • Masking: Triple

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
Placebo Comparator: Placebo
Drug: Placebo
Placebo
Experimental: 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
Drug: Single dose of celecoxib 400 mg and pregabalin 150 mg
Single dose of celecoxib 400 mg and pregabalin 150 mg
Active Comparator: 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
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

What is the study measuring?

Primary Outcome Measures

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

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Indonesia University

Investigators

  • Study Director: Andri MT Lubis, Department of Orthopaedic and Traumatology, Faculty of Medicine, Universitas Indonesia

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

General Publications

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Anticipated)

October 1, 2022

Primary Completion (Anticipated)

April 1, 2023

Study Completion (Anticipated)

April 30, 2023

Study Registration Dates

First Submitted

August 19, 2022

First Submitted That Met QC Criteria

August 19, 2022

First Posted (Actual)

August 22, 2022

Study Record Updates

Last Update Posted (Actual)

August 24, 2022

Last Update Submitted That Met QC Criteria

August 21, 2022

Last Verified

August 1, 2022

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • ID2564

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

No

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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