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

Primary Purpose

Knee Osteoarthritis

Status
Recruiting
Phase
Phase 4
Locations
Thailand
Study Type
Interventional
Intervention
Pregabalin 75mg
Pregabalin 150mg
Sponsored by
Thammasat University
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Knee Osteoarthritis focused on measuring Total Knee Arthroplasty, Pregabalin

Eligibility Criteria

55 Years - 80 Years (Adult, Older Adult)All SexesDoes not accept healthy volunteers

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

Sites / Locations

  • Thammasat University HospitalRecruiting

Arms of the Study

Arm 1

Arm 2

Arm Type

Experimental

Active Comparator

Arm Label

75 mg of Pregabalin

150 mg of Pregabalin

Arm Description

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

Participant received 2 tabs of 75 mg of Pregabalin

Outcomes

Primary Outcome Measures

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

Secondary Outcome Measures

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
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
Difference on length of stay between 75 mg of Pregabalin and 150 mg of Pregabalin groups
Time to discharge
Difference on time to ambulation between 75 mg of Pregabalin and 150 mg of Pregabalin groups
Time from operation to ambulation before hospital discharge
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
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
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
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.
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.

Full Information

First Posted
June 26, 2022
Last Updated
July 1, 2022
Sponsor
Thammasat University
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1. Study Identification

Unique Protocol Identification Number
NCT05447364
Brief Title
Efficacy of Different Doses of Pregabalin as a Multimodal Analgesic Agent in Postoperative Pain Control After Total Knee Arthroplasty
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
Study Type
Interventional

2. Study Status

Record Verification Date
July 2022
Overall Recruitment Status
Recruiting
Study Start Date
July 1, 2021 (Actual)
Primary Completion Date
January 1, 2024 (Anticipated)
Study Completion Date
January 1, 2024 (Anticipated)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Principal Investigator
Name of the Sponsor
Thammasat University

4. Oversight

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
Data Monitoring Committee
Yes

5. Study Description

Brief 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.
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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Knee Osteoarthritis
Keywords
Total Knee Arthroplasty, Pregabalin

7. Study Design

Primary Purpose
Treatment
Study Phase
Phase 4
Interventional Study Model
Parallel Assignment
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
ParticipantInvestigator
Allocation
Randomized
Enrollment
82 (Anticipated)

8. Arms, Groups, and Interventions

Arm Title
75 mg of Pregabalin
Arm Type
Experimental
Arm Description
Participant received 1 tab of 75 mg of Pregabalin and 1 tab of placebo
Arm Title
150 mg of Pregabalin
Arm Type
Active Comparator
Arm Description
Participant received 2 tabs of 75 mg of Pregabalin
Intervention Type
Drug
Intervention Name(s)
Pregabalin 75mg
Intervention Description
1 tab of Pregabalin Brillior 75 mg and 1 tab of Placebo
Intervention Type
Drug
Intervention Name(s)
Pregabalin 150mg
Intervention Description
2 tabs of Pregabalin Brillior 75 mg
Primary Outcome Measure Information:
Title
Difference on 100-mm Visual analog scale (VAS) Pain Score between 75 mg of Pregabalin and 150 mg of Pregabalin groups
Description
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
Time Frame
6, 12, 18, 24, 48 hours & 2, 6, 12 weeks after surgery
Secondary Outcome Measure Information:
Title
Difference on Morphine consumption between 75 mg of Pregabalin and 150 mg of Pregabalin groups
Description
Amount of Morphine consumption as rescue pain control reported as mg per day
Time Frame
From postoperative period until 48 hours after surgery
Title
Difference on side effects between 75 mg of Pregabalin and 150 mg of Pregabalin groups
Description
Common of side effects of Pregabalin and Morphine including sedation, dizziness, visual disturbances, nausea and vomiting
Time Frame
6, 12, 18, 24, 48 hours & 2, 6, 12 weeks after surgery
Title
Difference on length of stay between 75 mg of Pregabalin and 150 mg of Pregabalin groups
Description
Time to discharge
Time Frame
From postoperative period until 48 hours after surgery
Title
Difference on time to ambulation between 75 mg of Pregabalin and 150 mg of Pregabalin groups
Description
Time from operation to ambulation before hospital discharge
Time Frame
From postoperative period until 48 hours after surgery
Title
Difference on Range of motion between 75 mg of Pregabalin and 150 mg of Pregabalin groups
Description
- Flexion and extension angle of the knee is measured by a long-arm goniometer
Time Frame
2, 6, 12 weeks after surgery
Title
Difference on Knee Society Score between 75 mg of Pregabalin and 150 mg of Pregabalin groups
Description
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
Time Frame
2, 6, 12 weeks after surgery
Title
Difference on Knee injury and Osteoarthritis Outcome Score between 75 mg of Pregabalin and 150 mg of Pregabalin groups
Description
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
Time Frame
2, 6, 12 weeks after surgery
Title
Difference on Time up-and-go test between between 75 mg of Pregabalin and 150 mg of Pregabalin groups
Description
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.
Time Frame
2, 6, 12 weeks after surgery
Title
Difference on 2-minutes walking test between 75 mg of Pregabalin and 150 mg of Pregabalin groups
Description
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.
Time Frame
2, 6, 12 weeks after surgery

10. Eligibility

Sex
All
Minimum Age & Unit of Time
55 Years
Maximum Age & Unit of Time
80 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
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
Central Contact Person:
First Name & Middle Initial & Last Name or Official Title & Degree
SEKSAN KUKREJA, M.D.
Phone
66850218688
Email
thesekku@gmail.com
Facility Information:
Facility Name
Thammasat University Hospital
City
Pathum Thani
State/Province
Pathumthani
ZIP/Postal Code
12120
Country
Thailand
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
SEKSAN KUKREJA, M.D.
Phone
66850218688
Email
thesekku@gmail.com
First Name & Middle Initial & Last Name & Degree
Piya Pinsornsak, M.D.
First Name & Middle Initial & Last Name & Degree
Krit Boontanapibul, M.D.

12. IPD Sharing Statement

Plan to Share IPD
Yes
IPD Sharing 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.
Citations:
PubMed Identifier
25209095
Citation
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Results Reference
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Citation
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.
Results Reference
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24051389
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Results Reference
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PubMed Identifier
31985507
Citation
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.
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19910619
Citation
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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.
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Citation
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.
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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.
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Efficacy of Different Doses of Pregabalin as a Multimodal Analgesic Agent in Postoperative Pain Control After Total Knee Arthroplasty

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