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Completed

NCT Number: NCT05447364

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

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.

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Key information

Age range

55 year–80 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Phase 4

Primary location

Thammasat University Hospital

Pathum Thani, Changwat Pathum Thani, 12120, Thailand

About this study

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.

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

Inclusion criteria

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

Exclusion criteria

  • 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

Treatment and study plan

Pregabalin 75mg

Drug

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

Pregabalin 150mg

Drug

2 tabs of Pregabalin Brillior 75 mg

Primary outcomes

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

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

    • 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

Secondary outcomes

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

    Time frame: From postoperative period until 48 hours after surgery

    Amount of Morphine consumption as rescue pain control reported as mg per day

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

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

    Common of side effects of Pregabalin and Morphine including sedation, dizziness, visual disturbances, nausea and vomiting

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

    Time frame: From postoperative period until 48 hours after surgery

    Time to discharge

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

    Time frame: From postoperative period until 48 hours after surgery

    Time from operation to ambulation before hospital discharge

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

    Time frame: 2, 6, 12 weeks after surgery

    • Flexion and extension angle of the knee is measured by a long-arm goniometer
  6. Difference on Knee Society Score between 75 mg of Pregabalin and 150 mg of Pregabalin groups

    Time frame: 2, 6, 12 weeks after surgery

    • The Knee Society Score is a validated, objective scoring system to evaluate patient's functional abilities before and after total knee arthroplasty
    • The Knee Society Score has 2 sections including Knee Score and Functional Score with both sections scored from 0 to 100
    • Higher scores on the Knee Society Score indicate better knee conditions
  7. Difference on Knee injury and Osteoarthritis Outcome Score between 75 mg of Pregabalin and 150 mg of Pregabalin groups

    Time frame: 2, 6, 12 weeks after surgery

    • The Knee injury and Osteoarthritis Outcome Score is a validated, patient reported joint-specific score to assess patient pain (9 items), other symptoms (7 items), function in daily living (17 items), function in sport and recreation (5 items), and knee related quality of life (4 items)
    • The Knee injury and Osteoarthritis Outcome Score range from 0 to 100
    • Higher scores on the Knee injury and Osteoarthritis Outcome Score indicate better knee conditions
  8. Difference on Time up-and-go test between between 75 mg of Pregabalin and 150 mg of Pregabalin groups

    Time frame: 2, 6, 12 weeks after surgery

    • The Time up-and-go test (TUGT) measures the time (seconds) that the patient takes to rise from a chair and walk for 3 meters. Then, he or she turns around and comes back to the seat at the initial position.
    • They were permitted to use walking aids if they wished.
    • TUGT was a reliable and valid test for quantifying functional mobility.
  9. Difference on 2-minutes walking test between 75 mg of Pregabalin and 150 mg of Pregabalin groups

    Time frame: 2, 6, 12 weeks after surgery

    • Participants were instructed to walk for 2 minutes at their normal pace up and down a designated corridor, turning around at each end of the corridor without stopping
    • They were permitted to use walking aids if they wished.
    • The results were recorded as the total distance walked in meters.

Sponsors and collaborators

Lead sponsor

Thammasat University

Other

Registry information

Official study title

Efficacy of Different Doses of Pregabalin as a Multimodal Analgesic Agent in Postoperative Pain Control After Total Knee Arthroplasty - A Randomized Controlled Trial

Important dates

Study start
2021
Primary completion
2023
Study completion
2024
First posted
Jul 7, 2022
Registry last updated
Apr 16, 2024

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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