Clinical trial NCT05509946: Preemptive Analgesia Combination of Celecoxib and Pregabalin in THA
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)
Study type: INTERVENTIONAL
Overall status: UNKNOWN
Phase: PHASE2
PHASE3
Conditions: Arthroplasty Complications
Analgetic
Celecoxib
Pregabalin
Keywords: total hip arthroplasty
celecoxib
pregabalin
preemptive analgetic
Lead sponsor: Indonesia University
Sponsor class: OTHER
First posted: 2022-08-22
Enrollment: 30
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: yes
Allocation: RANDOMIZED
Intervention model: PARALLEL
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
Primary purpose: TREATMENT

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

Eligibility criteria: 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

Primary outcomes:
measure: Postoperative Pain
timeFrame: After surgery for three days
measure: Total consumption of morphine
timeFrame: Three days
Secondary outcomes:
Other outcomes:
Locations:
Study officials:
affiliation: Department of Orthopaedic and Traumatology, Faculty of Medicine, Universitas Indonesia
name: Andri MT Lubis
role: STUDY_DIRECTOR
References:
citation: 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.
citation: 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.
citation: 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.
citation: 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.
citation: 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.
citation: 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.
citation: 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.
citation: 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.