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

NCT ID: NCT05447364

Last Updated: 2024-04-16

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

COMPLETED

Clinical Phase

PHASE4

Total Enrollment

82 participants

Study Classification

INTERVENTIONAL

Study Start Date

2021-07-01

Study Completion Date

2024-03-01

Brief Summary

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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.

Detailed Description

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After being informed about the study and potential risks, all patients giving written informed consent will be chosen for eligibility for the study entry. At the day before surgery date, patients who meet the eligibility criteria will be randomized in a double-blind manner (participant and investigator) in a 1:1 ratio to 75 mg of Pregabalin and 150 mg of Pregabalin groups.

Conditions

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Knee Osteoarthritis

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

Participants are randomized and assigned to 75 mg of Pregabalin and 150 of Pregabalin groups in parallel for the duration of the study
Primary Study Purpose

TREATMENT

Blinding Strategy

DOUBLE

Participants Investigators

Study Groups

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75 mg of Pregabalin

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

Group Type EXPERIMENTAL

Pregabalin 75mg

Intervention Type DRUG

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

150 mg of Pregabalin

Participant received 2 tabs of 75 mg of Pregabalin

Group Type ACTIVE_COMPARATOR

Pregabalin 150mg

Intervention Type DRUG

2 tabs of Pregabalin Brillior 75 mg

Interventions

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Pregabalin 75mg

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

Intervention Type DRUG

Pregabalin 150mg

2 tabs of Pregabalin Brillior 75 mg

Intervention Type DRUG

Eligibility Criteria

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Inclusion Criteria

1. Symptomatic primary knee osteoarthritis undergoing unilateral TKA
2. Aged between 55 and 80 years old
3. Comply with protocol

Exclusion Criteria

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

55 Years

Maximum Eligible Age

80 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No

Sponsors

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Thammasat University

OTHER

Sponsor Role lead

Responsible Party

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Seksan Kukreja

Principal Investigator

Responsibility Role PRINCIPAL_INVESTIGATOR

Locations

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Thammasat University Hospital

Pathum Thani, Changwat Pathum Thani, Thailand

Site Status

Countries

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Thailand

References

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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.

Reference Type RESULT
PMID: 25209095 (View on PubMed)

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.

Reference Type RESULT
PMID: 28705543 (View on PubMed)

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.

Reference Type RESULT
PMID: 24051389 (View on PubMed)

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.

Reference Type RESULT
PMID: 31985507 (View on PubMed)

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.

Reference Type RESULT
PMID: 19910619 (View on PubMed)

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.

Reference Type RESULT
PMID: 18716003 (View on PubMed)

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.

Reference Type RESULT
PMID: 23325966 (View on PubMed)

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.

Reference Type RESULT
PMID: 31733981 (View on PubMed)

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.

Reference Type RESULT
PMID: 24630598 (View on PubMed)

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.

Reference Type RESULT
PMID: 29454556 (View on PubMed)

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.

Reference Type RESULT
PMID: 26170351 (View on PubMed)

Other Identifiers

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MTU-EC-OT-6-150/64

Identifier Type: -

Identifier Source: org_study_id

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