Efficacy of Different Doses of Pregabalin as a Multimodal Analgesic Agent in Postoperative Pain Control After Total Knee Arthroplasty

NCT05447364 | Completed Phase 4 DMC

• 1 other identifier: MTU-EC-OT-6-150/64
• Study Type: interventional
• Target: 82
• Locations: 1 country
• Sites: 1

Brief Summary

The purpose of this study is to compare the efficacy of 75 mg of Pregabalin and 150 mg of Pregabalin in postoperative pain control after TKA.

Conditions

Knee Osteoarthritis

Keywords

Total Knee Arthroplasty; Pregabalin

Outcome Measures

Primary Outcomes (1)

• Difference on 100-mm Visual analog scale (VAS) Pain Score between 75 mg of Pregabalin and 150 mg of Pregabalin groups

  * The 100-mm VAS pain score is a self-reported instrument assessing pain scores. * Participants will assess the VAS pain score at rest and on-movement * VAS Pain at rest is evaluated when the participant is at rest. * VAS Pain on-movement is evaluated on active extension and flexion of the operated knee using mean scores between the two. * Possible scores range from 0 (no pain) to 100 (worst imaginable pain) * Higher scores mean a worse pain

  6, 12, 18, 24, 48 hours & 2, 6, 12 weeks after surgery

Secondary Outcomes (9)

• Difference on Morphine consumption between 75 mg of Pregabalin and 150 mg of Pregabalin groups

  From postoperative period until 48 hours after surgery

• Difference on side effects between 75 mg of Pregabalin and 150 mg of Pregabalin groups

  6, 12, 18, 24, 48 hours & 2, 6, 12 weeks after surgery

• Difference on length of stay between 75 mg of Pregabalin and 150 mg of Pregabalin groups

  From postoperative period until 48 hours after surgery

• Difference on time to ambulation between 75 mg of Pregabalin and 150 mg of Pregabalin groups

  From postoperative period until 48 hours after surgery

• Difference on Range of motion between 75 mg of Pregabalin and 150 mg of Pregabalin groups

  2, 6, 12 weeks after surgery

Study Arms (2)

75 mg of Pregabalin

EXPERIMENTAL

Participant received 1 tab of 75 mg of Pregabalin and 1 tab of placebo

Drug: Pregabalin 75mg

150 mg of Pregabalin

ACTIVE COMPARATOR

Participant received 2 tabs of 75 mg of Pregabalin

Drug: Pregabalin 150mg

Interventions

Pregabalin 75mg DRUG

1 tab of Pregabalin Brillior 75 mg and 1 tab of Placebo

75 mg of Pregabalin

Pregabalin 150mg DRUG

2 tabs of Pregabalin Brillior 75 mg

150 mg of Pregabalin

Eligibility Criteria

• Age: 55 Years - 80 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• Symptomatic primary knee osteoarthritis undergoing unilateral TKA
• Aged between 55 and 80 years old
• Comply with protocol

You may not qualify if:

• Allergy to any of the medications in this protocol (Pregabalin, Morphine, Paracetamol, Celecoxib, Tramadol, Aspirin)
• Secondary osteoarthritis of the knee including autoimmune diseases and post-traumatic
• Previous surgery on the knee
• Contraindicated to spinal anesthesia (SB) or Adductor canal block (ACB)
• GFR \< 30ml/min, Severe Liver Function (Child-Pugh C)
• History of seizure or cerebrovascular diseases

Sponsors & Collaborators

• Thammasat University: lead

Study Sites (1)

Thammasat University Hospital

Pathum Thani, Changwat Pathum Thani, 12120, Thailand

Location

Related Publications (11)

• Mishriky BM, Waldron NH, Habib AS. Impact of pregabalin on acute and persistent postoperative pain: a systematic review and meta-analysis. Br J Anaesth. 2015 Jan;114(1):10-31. doi: 10.1093/bja/aeu293. Epub 2014 Sep 10.

  PMID: 25209095 RESULT

• Golladay GJ, Balch KR, Dalury DF, Satpathy J, Jiranek WA. Oral Multimodal Analgesia for Total Joint Arthroplasty. J Arthroplasty. 2017 Sep;32(9S):S69-S73. doi: 10.1016/j.arth.2017.05.002. Epub 2017 May 11.

  PMID: 28705543 RESULT

• Schmidt PC, Ruchelli G, Mackey SC, Carroll IR. Perioperative gabapentinoids: choice of agent, dose, timing, and effects on chronic postsurgical pain. Anesthesiology. 2013 Nov;119(5):1215-21. doi: 10.1097/ALN.0b013e3182a9a896. No abstract available.

  PMID: 24051389 RESULT

• Summers S, Mohile N, McNamara C, Osman B, Gebhard R, Hernandez VH. Analgesia in Total Knee Arthroplasty: Current Pain Control Modalities and Outcomes. J Bone Joint Surg Am. 2020 Apr 15;102(8):719-727. doi: 10.2106/JBJS.19.01035. No abstract available.

  PMID: 31985507 RESULT

• Buvanendran A, Kroin JS, Della Valle CJ, Kari M, Moric M, Tuman KJ. Perioperative oral pregabalin reduces chronic pain after total knee arthroplasty: a prospective, randomized, controlled trial. Anesth Analg. 2010 Jan 1;110(1):199-207. doi: 10.1213/ANE.0b013e3181c4273a. Epub 2009 Nov 12.

  PMID: 19910619 RESULT

• Agarwal A, Gautam S, Gupta D, Agarwal S, Singh PK, Singh U. Evaluation of a single preoperative dose of pregabalin for attenuation of postoperative pain after laparoscopic cholecystectomy. Br J Anaesth. 2008 Nov;101(5):700-4. doi: 10.1093/bja/aen244. Epub 2008 Aug 20.

  PMID: 18716003 RESULT

• Jain P, Jolly A, Bholla V, Adatia S, Sood J. Evaluation of efficacy of oral pregabalin in reducing postoperative pain in patients undergoing total knee arthroplasty. Indian J Orthop. 2012 Nov;46(6):646-52. doi: 10.4103/0019-5413.104196.

  PMID: 23325966 RESULT

• Azboy I, Groff H, Goswami K, Vahedian M, Parvizi J. Low-Dose Aspirin Is Adequate for Venous Thromboembolism Prevention Following Total Joint Arthroplasty: A Systematic Review. J Arthroplasty. 2020 Mar;35(3):886-892. doi: 10.1016/j.arth.2019.09.043. Epub 2019 Oct 5.

  PMID: 31733981 RESULT

• Noiseux NO, Callaghan JJ, Clark CR, Zimmerman MB, Sluka KA, Rakel BA. Preoperative predictors of pain following total knee arthroplasty. J Arthroplasty. 2014 Jul;29(7):1383-7. doi: 10.1016/j.arth.2014.01.034. Epub 2014 Feb 7.

  PMID: 24630598 RESULT

• Unnanuntana A, Ruangsomboon P, Keesukpunt W. Validity and Responsiveness of the Two-Minute Walk Test for Measuring Functional Recovery After Total Knee Arthroplasty. J Arthroplasty. 2018 Jun;33(6):1737-1744. doi: 10.1016/j.arth.2018.01.015. Epub 2018 Jan 31.

  PMID: 29454556 RESULT

• YaDeau JT, Lin Y, Mayman DJ, Goytizolo EA, Alexiades MM, Padgett DE, Kahn RL, Jules-Elysee KM, Ranawat AS, Bhagat DD, Fields KG, Goon AK, Curren J, Westrich GH. Pregabalin and pain after total knee arthroplasty: a double-blind, randomized, placebo-controlled, multidose trial. Br J Anaesth. 2015 Aug;115(2):285-93. doi: 10.1093/bja/aev217.

  PMID: 26170351 RESULT

MeSH Terms

Conditions

Osteoarthritis, Knee

Interventions

Pregabalin

Condition Hierarchy (Ancestors)

Osteoarthritis; Arthritis; Joint Diseases; Musculoskeletal Diseases; Rheumatic Diseases

Intervention Hierarchy (Ancestors)

gamma-Aminobutyric Acid; Aminobutyrates; Butyrates; Acids, Acyclic; Carboxylic Acids; Organic Chemicals; Amino Acids; Amino Acids, Peptides, and Proteins

Study Design

• Study Type: interventional
• Phase: phase 4
• Allocation: RANDOMIZED
• Masking: DOUBLE
• Who Masked: PARTICIPANT, INVESTIGATOR
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Principal Investigator

Model Details: Participants are randomized and assigned to 75 mg of Pregabalin and 150 of Pregabalin groups in parallel for the duration of the study

Study Record Dates

• First Submitted: June 26, 2022
• First Posted: July 7, 2022
• Study Start: July 1, 2021
• Primary Completion: September 1, 2023
• Study Completion: March 1, 2024
• Last Updated: April 16, 2024

Record last verified: 2024-04

Data Sharing

• IPD Sharing: Will share
• Shared Documents: STUDY PROTOCOL, SAP, ANALYTIC CODE
• Time Frame: Beginning 3 months and ending 5 years following article publication.
• Access Criteria: * Researchers who provide a methodologically sound proposal. * To achieve aims in the approved proposal. * Proposals should be directed to thesekku@gmail.com. * To gain access, data requestors will need to sign a data access agreement.

Locations

TH (1)