Preemptive Analgesia Combination of Celecoxib and Pregabalin in THA
NCT ID: NCT05509946
Last Updated: 2022-08-24
Study Results
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Basic Information
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UNKNOWN
PHASE2/PHASE3
30 participants
INTERVENTIONAL
2022-10-01
2023-04-30
Brief Summary
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Detailed Description
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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
Conditions
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Study Design
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RANDOMIZED
PARALLEL
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
TREATMENT
TRIPLE
Study Groups
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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
Single dose of celecoxib 400 mg and pregabalin 150 mg
Single dose of celecoxib 400 mg and pregabalin 150 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
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
Placebo
Placebo
Placebo
Interventions
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Single dose of celecoxib 400 mg and pregabalin 150 mg
Single dose of celecoxib 400 mg and pregabalin 150 mg
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
Placebo
Eligibility Criteria
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Inclusion Criteria
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
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
18 Years
ALL
Yes
Sponsors
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Indonesia University
OTHER
Responsible Party
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Kemas Muhammad Azka Novriandi
Medical doctor, Orthopaedic Surgeon, Principal Investigator
Principal Investigators
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Andri MT Lubis
Role: STUDY_DIRECTOR
Department of Orthopaedic and Traumatology, Faculty of Medicine, Universitas Indonesia
Central Contacts
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References
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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.
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.
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.
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.
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. doi: 10.1054/arth.2000.4346.
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. doi: 10.2106/00004623-200211000-00006.
Pinto PR, McIntyre T, Araujo-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.
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.
Other Identifiers
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ID2564
Identifier Type: -
Identifier Source: org_study_id
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