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

Status

Indicates the current recruitment status or the expanded access status.
Completed

Conditions

Conditions

The disease, disorder, syndrome, illness, or injury that is being studied. On ClinicalTrials.gov, conditions may also include other health-related issues, such as lifespan, quality of life, and health risks.

Intervention / Treatment

Intervention / Treatment

A process or action that is the focus of a clinical study. Interventions include drugs, medical devices, procedures, vaccines, and other products that are either investigational or already available. Interventions can also include noninvasive approaches, such as education or modifying diet and exercise.

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

Study Type

Describes the nature of a clinical study. Study types include interventional studies (also called clinical trials), observational studies (including patient registries), and expanded access.
Interventional

Enrollment (Actual)

Enrollment

The number of participants in a clinical study. The "anticipated" enrollment is the target number of participants that the researchers need for the study.
82

Phase

Phase

The stage of a clinical trial studying a drug or biological product, based on definitions developed by the U.S. Food and Drug Administration (FDA). The phase is based on the study's objective, the number of participants, and other characteristics. There are five phases: Early Phase 1 (formerly listed as Phase 0), Phase 1, Phase 2, Phase 3, and Phase 4. Not Applicable is used to describe trials without FDA-defined phases, including trials of devices or behavioral interventions.
  • 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 Contact

Study Contact

The name and contact information for the person who can answer enrollment questions for a clinical study. Each location where the study is being conducted may also have a specific contact, who may be better able to answer those questions.

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

Eligibility Criteria

The key requirements that people who want to participate in a clinical study must meet or the characteristics they must have. Eligibility criteria consist of both inclusion criteria (which are required for a person to participate in the study) and exclusion criteria (which prevent a person from participating). Types of eligibility criteria include whether a study accepts healthy volunteers, has age or age group requirements, or is limited by sex.

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

Participant Group / Arm

A group or subgroup of participants in a clinical trial that receives a specific intervention/treatment, or no intervention, according to the trial's protocol.
Intervention / Treatment

Intervention / Treatment

A process or action that is the focus of a clinical study. Interventions include drugs, medical devices, procedures, vaccines, and other products that are either investigational or already available. Interventions can also include noninvasive approaches, such as education or modifying diet and exercise.
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

Primary Outcome Measures

In a clinical study's protocol, the planned outcome measure that is the most important for evaluating the effect of an intervention/treatment. Most clinical studies have one primary outcome measure, but some have more than one.
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

Secondary Outcome Measures

In a clinical study's protocol, a planned outcome measure that is not as important as the primary outcome measure for evaluating the effect of an intervention but is still of interest. Most clinical studies have more than one secondary outcome measure.
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

Sponsor

The organization or person who initiates the study and who has authority and control over the study.
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)

Study Start

The actual date on which the first participant was enrolled in a clinical study. The "anticipated" study start date is the date that the researchers think will be the study start date.
July 1, 2021

Primary Completion (Actual)

Primary Completion

The date on which the last participant in a clinical study was examined or received an intervention to collect final data for the primary outcome measure. Whether the clinical study ended according to the protocol or was terminated does not affect this date. For clinical studies with more than one primary outcome measure with different completion dates, this term refers to the date on which data collection is completed for all the primary outcome measures. The "anticipated" primary completion date is the date that the researchers think will be the primary completion date for the study.
September 1, 2023

Study Completion (Actual)

Study Completion

The date on which the last participant in a clinical study was examined or received an intervention/treatment to collect final data for the primary outcome measures, secondary outcome measures, and adverse events (that is, the last participant's last visit). The "anticipated" study completion date is the date that the researchers think will be the study completion date.
March 1, 2024

Study Registration Dates

First Submitted

First Submitted

The date on which the study sponsor or investigator first submitted a study record to ClinicalTrials.gov. There is typically a delay of a few days between the first submitted date and the record's availability on ClinicalTrials.gov (the first posted date).
June 26, 2022

First Submitted That Met QC Criteria

First Submitted That Met QC Criteria

The date on which the study sponsor or investigator first submits a study record that is consistent with National Library of Medicine (NLM) quality control (QC) review criteria. The sponsor or investigator may need to revise and submit a study record one or more times before NLM's QC review criteria are met. It is the responsibility of the sponsor or investigator to ensure that the study record is consistent with the NLM QC review criteria.
July 1, 2022

First Posted (Actual)

First Posted

The date on which the study record was first available on ClinicalTrials.gov after National Library of Medicine (NLM) quality control (QC) review has concluded. There is typically a delay of a few days between the date the study sponsor or investigator submitted the study record and the first posted date.
July 7, 2022

Study Record Updates

Last Update Posted (Actual)

Last Update Posted

The most recent date on which changes to a study record were made available on ClinicalTrials.gov. There may be a delay between when the changes were submitted to ClinicalTrials.gov by the study's sponsor or investigator (the last update submitted date) and the last update posted date.
April 16, 2024

Last Update Submitted That Met QC Criteria

Last Update Submitted That Met QC Criteria

The most recent date on which the study sponsor or investigator submitted changes to a study record that are consistent with National Library of Medicine (NLM) quality control (QC) review criteria. It is the responsibility of the sponsor or investigator to ensure that the study record is consistent with the NLM QC review criteria.
April 14, 2024

Last Verified

Last Verified

The most recent date on which the study sponsor or investigator confirmed the information about a clinical study on ClinicalTrials.gov as accurate and current. If a study with a recruitment status of recruiting; not yet recruiting; or active, not recruiting has not been confirmed within the past 2 years, the study's recruitment status is shown as unknown.
April 1, 2024

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

Other Study ID Numbers

Identifiers or ID numbers other than the NCT number that are assigned to a clinical study by the study's sponsor, funders, or others. These numbers may include unique identifiers from other trial registries and National Institutes of Health grant 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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