Preemptive Analgesia Combination of Celecoxib and Pregabalin in THA

NCT05509946 | Unknown Phase 2

• 1 other identifier: ID2564
• Study Type: interventional
• Target: 30
• Locations: 0 countries
• Sites: N/A

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.

Conditions

Arthroplasty Complications; Analgetic; Celecoxib; Pregabalin

Keywords

total hip arthroplasty; celecoxib; pregabalin; preemptive analgetic

Outcome Measures

Primary Outcomes (2)

• Postoperative Pain

  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

  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

Study Arms (3)

Single dose of celecoxib 400 mg and pregabalin 150 mg

EXPERIMENTAL

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

Repeated dose of celecoxib 200 mg and pregabalin 75 mg

ACTIVE COMPARATOR

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

Placebo

PLACEBO COMPARATOR

Placebo

Drug: Placebo

Interventions

Single dose of celecoxib 400 mg and pregabalin 150 mg DRUG

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 DRUG

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

Repeated dose of celecoxib 200 mg and pregabalin 75 mg

Placebo DRUG

Placebo

Placebo

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• Patients \>18 years old
• Patients who come to the RSCM Orthopedic Polyclinic
• Patients undergoing THA operasi surgery
• Patients with Primary and Secondary Pelvic Osteoarthritis
• The patient is taking anti-pain and anti-inflammatory drugs regularly

You may not qualify if:

• 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

Sponsors & Collaborators

• Indonesia University: lead

Related Publications (8)

• 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.

  PMID: 18033565 BACKGROUND

• 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.

  PMID: 23375960 BACKGROUND

• 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.

  PMID: 22461810 BACKGROUND

• 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.

  PMID: 20951814 BACKGROUND

• 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.

  PMID: 10884204 BACKGROUND

• 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.

  PMID: 12429753 BACKGROUND

• 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.

  PMID: 28533697 BACKGROUND

• 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.

  PMID: 28088207 BACKGROUND

MeSH Terms

Interventions

Celecoxib; Pregabalin

Intervention Hierarchy (Ancestors)

Benzenesulfonamides; Sulfonamides; Amides; Organic Chemicals; Benzene Derivatives; Hydrocarbons, Aromatic; Hydrocarbons, Cyclic; Hydrocarbons; Sulfones; Sulfur Compounds; Pyrazoles; Azoles; Heterocyclic Compounds, 1-Ring; Heterocyclic Compounds; gamma-Aminobutyric Acid; Aminobutyrates; Butyrates; Acids, Acyclic; Carboxylic Acids; Amino Acids; Amino Acids, Peptides, and Proteins

Study Officials

• Andri MT Lubis

  Department of Orthopaedic and Traumatology, Faculty of Medicine, Universitas Indonesia

  STUDY DIRECTOR

Central Study Contacts

Kemas MA Novriandi, MD

CONTACT

+628194830011; Azkanovriandi1991@gmail.com

Study Design

• Study Type: interventional
• Phase: phase 2
• Allocation: RANDOMIZED
• Masking: TRIPLE
• Who Masked: PARTICIPANT, CARE PROVIDER, INVESTIGATOR
• Masking Details: 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
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Medical doctor, Orthopaedic Surgeon, Principal Investigator

Model Details: 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

Study Record Dates

• First Submitted: August 19, 2022
• First Posted: August 22, 2022
• Study Start: October 1, 2022
• Primary Completion: April 1, 2023
• Study Completion: April 30, 2023
• Last Updated: August 24, 2022

Record last verified: 2022-08

Data Sharing

• IPD Sharing: Will not share