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Knee OsteoarthritisPhase 4NCT05447364

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

A Phase 4 study testing Pregabalin 75mg and Pregabalin 150mg in people with Knee Osteoarthritis, run by Thammasat University at 1 site in Thailand.

Completed

Finished. The study has ended and is not enrolling. Results may be posted on the official record.

Official record
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Trial 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. Read more about this study

Who is it for?
Ages 55 to 80 years
Conditions the study is for
Knee Osteoarthritis
What is being tested?
Pregabalin 75mg and Pregabalin 150mg
Could I receive a placebo?
No, everyone receives an active treatment
How many people
82 participants
Where
1 siteThailand
Study dates
1 Jul 2021to 1 Mar 2024
Phase
Phase 4
Are there results?
None posted in the registry

Key requirements

Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.

  • Ages 55 to 80 years
  • All sexes
  • No healthy volunteers
  • Adult, Older adult

Who may be able to join

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

Who cannot join

  • 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

Trial locations and contacts

1 site in 1 country.

Thailand1 site

  • Thammasat University Hospital

    Pathum Thani, Changwat Pathum Thani, 12120

Other trials in Thailand

About this study

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

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.

Read the detailed description

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.

Being tested
Pregabalin 75mg, Pregabalin 150mg
Keywords
Total Knee Arthroplasty, Pregabalin
Medical subject headings
Osteoarthritis, Knee

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

  • Pregabalin 75mgDrug

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

  • Pregabalin 150mgDrug

    2 tabs of Pregabalin Brillior 75 mg

Study groups in NCT05447364
Study groupRoleWhat they receive
75 mg of PregabalinExperimentalParticipant received 1 tab of 75 mg of Pregabalin and 1 tab of placebo
Receives: Drug: Pregabalin 75mg
150 mg of PregabalinActive comparatorParticipant received 2 tabs of 75 mg of Pregabalin
Receives: Drug: Pregabalin 150mg

What is being measured

The primary outcome is the main question the study is designed to answer.

  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

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

Secondary outcomes (9)

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

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

    Measured: From postoperative period until 48 hours after surgery

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

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

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

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

    Time to discharge

    Measured: From postoperative period until 48 hours after surgery

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

    Time from operation to ambulation before hospital discharge

    Measured: From postoperative period until 48 hours after surgery

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

    • Flexion and extension angle of the knee is measured by a long-arm goniometer

    Measured: 2, 6, 12 weeks after surgery

  6. Difference on Knee Society Score between 75 mg of Pregabalin and 150 mg of Pregabalin groups

    • 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

    Measured: 2, 6, 12 weeks after surgery

  7. Difference on Knee injury and Osteoarthritis Outcome Score between 75 mg of Pregabalin and 150 mg of Pregabalin groups

    • 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

    Measured: 2, 6, 12 weeks after surgery

  8. Difference on Time up-and-go test between between 75 mg of Pregabalin and 150 mg of Pregabalin groups

    • 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.

    Measured: 2, 6, 12 weeks after surgery

  9. Difference on 2-minutes walking test between 75 mg of Pregabalin and 150 mg of Pregabalin groups

    • 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.

    Measured: 2, 6, 12 weeks after surgery

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

  1. First posted7 Jul 2022
  2. Study start1 Jul 2021
  3. Primary completion1 Sep 2023
  4. Study completion1 Mar 2024

Resources

More details

For doctors and researchers: how the study is designed, who runs it, and its registry IDs.

Study design
Study type
Interventional
Phase
Phase 4
Primary purpose
Treatment
Allocation
Randomised
Intervention model
Parallel groups
Model description
Participants are randomized and assigned to 75 mg of Pregabalin and 150 of Pregabalin groups in parallel for the duration of the study
Masking
Double blind
Who is masked
Participant, Investigator
Enrolment
82 participants (actual)
IDs, dates and publications
ClinicalTrials.gov ID
NCT05447364
Sponsor's protocol ID
MTU-EC-OT-6-150/64
Status last verified
Apr 2024
First submitted
26 Jun 2022
Last updated
16 Apr 2024
Results posted
No
Data monitoring committee
Yes
FDA-regulated drug
No
FDA-regulated device
No
Individual data sharing
Yes: Individual participant data that underlie the results reported in this article, after deidentification (text, tables, figures, and appendices)

Publications

  • 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.

    PubMed 25209095

  • 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.

    PubMed 28705543

  • 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.

    PubMed 24051389

  • 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.

    PubMed 31985507

  • 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.

    PubMed 19910619

  • 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.

    PubMed 18716003

  • 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.

    PubMed 23325966

  • 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.

    PubMed 31733981

  • 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.

    PubMed 24630598

  • 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.

    PubMed 29454556

  • 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.

    PubMed 26170351

Questions about this trial

What is this clinical trial studying?

A Phase 4 study testing Pregabalin 75mg and Pregabalin 150mg in people with Knee Osteoarthritis, run by Thammasat University at 1 site in Thailand.

The full registered description is in the About this study section and the official record.

Who may be eligible to take part?

The sponsor lists 3 inclusion and 6 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.

Is this clinical trial currently recruiting?

The record says: finished, as of the sponsor's last update on 16 Apr 2024. Status can change between updates, so confirm with the study contact before making plans.

Where is the study taking place?

The record lists 1 site in Thailand. Whether a site is taking part right now should be confirmed with that site. See every site.

What are the possible benefits and risks?

They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.

What does this phase mean?

Phase 4 studies take place after a treatment is approved, to learn more about its long-term benefits and risks in everyday use.

Not every study follows the same path, and some studies (observational studies, device studies) have no phase.

Are results available for this study?

The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.

How can a doctor refer a patient or contact the research team?

The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.

What does the primary outcome measure?

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). It is what the study was designed to measure, not a finding.

Where can I read the original study information?

On the ClinicalTrials.gov record for NCT05447364, which also lists 11 linked publications.

Does a listing mean the treatment is approved or proven to work?

No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.

How often is this information updated?

AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 16 Apr 2024.

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