Preemptive Analgesia Combination of Celecoxib and Pregabalin in THA

Arthroplasty Complications Clinical Trial

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)

Clinical Trial Details — Status: Not yet recruiting

Administrative data

• NCT number: NCT05509946
• Other study ID #: ID2564
• Status: Not yet recruiting
• Phase: Phase 2/Phase 3
• Start date: October 1, 2022
• Est. completion date: April 30, 2023

Study information

• Verified date: August 2022
• Source: Indonesia University
• Contact: Kemas MA Novriandi, MD
• Phone: +628194830011
• Email: Azkanovriandi1991[@]gmail.com
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

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

Recruitment information / eligibility

• Status: Not yet recruiting
• Enrollment: 30
• Est. completion date: April 30, 2023
• Est. primary completion date: April 1, 2023
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: All
• Age group: 18 Years and older

Eligibility

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

Related Conditions & MeSH terms

• Arthroplasty Complications
• Celecoxib
• Pregabalin

Intervention

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

Locations

Country	Name	City	State
n/a

Sponsors (1)

Lead Sponsor	Collaborator
Indonesia University

References & Publications (8)

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. — View 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. Review. — View 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. — View 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. — View 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. — View Citation

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. — View 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. — View 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. — View Citation

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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
Primary	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