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

April 14, 2024 updated by: Seksan Kukreja, Thammasat University

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.

Study Overview

Status

Completed

Conditions

Intervention / Treatment

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.

Study Type

Interventional

Enrollment (Actual)

82

Phase

  • Phase 4

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • Thailand
    • Pathumthani
      • Pathum Thani, Pathumthani, Thailand, 12120
        • Thammasat University Hospital

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

51 years to 76 years (Adult, Older Adult)

Accepts Healthy Volunteers

No

Description

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

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Treatment
  • Allocation: Randomized
  • Interventional Model: Parallel Assignment
  • Masking: Double

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
Experimental: 75 mg of Pregabalin
Participant received 1 tab of 75 mg of Pregabalin and 1 tab of placebo
Drug: Pregabalin 75mg
1 tab of Pregabalin Brillior 75 mg and 1 tab of Placebo
Active Comparator: 150 mg of Pregabalin
Participant received 2 tabs of 75 mg of Pregabalin
Drug: Pregabalin 150mg
2 tabs of Pregabalin Brillior 75 mg

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
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
6, 12, 18, 24, 48 hours & 2, 6, 12 weeks after surgery

Secondary Outcome Measures

Outcome Measure
Measure Description
Time Frame
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
From postoperative period until 48 hours after surgery
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
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
Time Frame: From postoperative period until 48 hours after surgery
Time to discharge
From postoperative period until 48 hours after surgery
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
From postoperative period until 48 hours after surgery
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
2, 6, 12 weeks after surgery
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
2, 6, 12 weeks after surgery
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
2, 6, 12 weeks after surgery
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.
2, 6, 12 weeks after surgery
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.
2, 6, 12 weeks after surgery

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Thammasat University

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

General Publications

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

July 1, 2021

Primary Completion (Actual)

September 1, 2023

Study Completion (Actual)

March 1, 2024

Study Registration Dates

First Submitted

June 26, 2022

First Submitted That Met QC Criteria

July 1, 2022

First Posted (Actual)

July 7, 2022

Study Record Updates

Last Update Posted (Actual)

April 16, 2024

Last Update Submitted That Met QC Criteria

April 14, 2024

Last Verified

April 1, 2024

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • MTU-EC-OT-6-150/64

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

YES

IPD Plan Description

Individual participant data that underlie the results reported in this article, after deidentification (text, tables, figures, and appendices)

IPD Sharing Time Frame

Beginning 3 months and ending 5 years following article publication.

IPD Sharing 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.

IPD Sharing Supporting Information Type

  • STUDY_PROTOCOL
  • SAP
  • ANALYTIC_CODE

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

No

product manufactured in and exported from the U.S.

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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