Preemptive Analgesia Combination of Celecoxib and Pregabalin in THA

• Sponsor: Indonesia University (Other)
• Overall Status: Not yet recruiting
• CT.gov ID: NCT05509946
• Collaborator: (none)
• Enrollment: 30
• Arms: 3
• Anticipated Duration (Months): 6.9

Study Details

Study Description

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.

Condition or Disease	Intervention/Treatment	Phase
Arthroplasty Complications; Analgetic; Celecoxib; Pregabalin	Drug: Single dose of celecoxib 400 mg and pregabalin 150 mg; Drug: Repeated dose of celecoxib 200 mg and pregabalin 75 mg; Drug: Placebo	Phase 2/Phase 3

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

1. 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 Design

• Study Type: Interventional
• Anticipated Enrollment: 30 participants
• Allocation: Randomized
• Intervention Model: Parallel Assignment
• Intervention 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 surgeryThere 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 (Participant, Care Provider, 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
• Primary Purpose: Treatment
• Official Title: 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)
• Anticipated Study Start Date: Oct 1, 2022
• Anticipated Primary Completion Date: Apr 1, 2023
• Anticipated Study Completion Date: Apr 30, 2023

Arms and Interventions

Arm	Intervention/Treatment
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
Placebo Comparator: Placebo Placebo	Drug: Placebo; Placebo

Outcome Measures

Primary Outcome Measures

1. 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

2. 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

Eligibility Criteria

Criteria

• Ages Eligible for Study: 18 Years and Older
• Sexes Eligible for Study: All
• Accepts 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

Contacts and Locations

Locations

No locations specified.

Sponsors and Collaborators

• Indonesia University

Investigators

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

Study Documents (Full-Text)

None provided.

More Information

Publications

• Arden NK, Kiran A, Judge A, Biant LC, Javaid MK, Murray DW, Carr AJ, Cooper C, Field RE. What is a good patient reported outcome after total hip replacement? Osteoarthritis Cartilage. 2011 Feb;19(2):155-62. doi: 10.1016/j.joca.2010.10.004. Epub 2010 Oct 15.
• Boisgard S, Descamps S, Bouillet B. Complex primary total hip arthroplasty. Orthop Traumatol Surg Res. 2013 Feb;99(1 Suppl):S34-42. doi: 10.1016/j.otsr.2012.11.008. Epub 2013 Feb 1. Review.
• Ferrata P, Carta S, Fortina M, Scipio D, Riva A, Di Giacinto S. Painful hip arthroplasty: definition. Clin Cases Miner Bone Metab. 2011 May;8(2):19-22.
• Hayes JH, Cleary R, Gillespie WJ, Pinder IM, Sher JL. Are clinical and patient assessed outcomes affected by reducing length of hospital stay for total hip arthroplasty? J Arthroplasty. 2000 Jun;15(4):448-52.
• Holtzman J, Saleh K, Kane R. Effect of baseline functional status and pain on outcomes of total hip arthroplasty. J Bone Joint Surg Am. 2002 Nov;84(11):1942-8.
• Pinto PR, McIntyre T, Araújo-Soares V, Costa P, Ferrero R, Almeida A. A comparison of predictors and intensity of acute postsurgical pain in patients undergoing total hip and knee arthroplasty. J Pain Res. 2017 May 9;10:1087-1098. doi: 10.2147/JPR.S126467. eCollection 2017.
• Sathappan SS, Strauss EJ, Ginat D, Upasani V, Di Cesare PE. Surgical challenges in complex primary total hip arthroplasty. Am J Orthop (Belle Mead NJ). 2007 Oct;36(10):534-41.
• Singh JA, Noorbaloochi S, Knutson KL. Cytokine and neuropeptide levels are associated with pain relief in patients with chronically painful total knee arthroplasty: a pilot study. BMC Musculoskelet Disord. 2017 Jan 14;18(1):17. doi: 10.1186/s12891-016-1375-2.

• Responsible Party: Kemas Muhammad Azka Novriandi, Medical doctor, Orthopaedic Surgeon, Principal Investigator, Indonesia University
• ClinicalTrials.gov Identifier: NCT05509946
• Other Study ID Numbers: ID2564
• First Posted: Aug 22, 2022
• Last Update Posted: Aug 24, 2022
• Last Verified: Aug 1, 2022

• Individual Participant Data (IPD) Sharing Statement: No
• Plan to Share IPD: No
• Studies a U.S. FDA-regulated Drug Product: No
• Studies a U.S. FDA-regulated Device Product: No
• Keywords provided by Kemas Muhammad Azka Novriandi, Medical doctor, Orthopaedic Surgeon, Principal Investigator, Indonesia University: total hip arthroplasty; celecoxib; pregabalin; preemptive analgetic
• Additional relevant MeSH terms: Celecoxib; Pregabalin

Study Results

No Results Posted as of Aug 24, 2022