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

• Sponsor: Thammasat University (Other)
• Overall Status: Recruiting
• CT.gov ID: NCT05447364
• Collaborator: (none)
• Enrollment: 82
• Location: 1
• Arms: 2
• Anticipated Duration (Months): 30
• Patients Per Site Per Month: 2.7

Study Details

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.

Condition or Disease	Intervention/Treatment	Phase
Knee Osteoarthritis	Drug: Pregabalin 75mg; Drug: Pregabalin 150mg	Phase 4

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 Design

• Study Type: Interventional
• Anticipated Enrollment: 82 participants
• Allocation: Randomized
• Intervention Model: Parallel Assignment
• Intervention Model Description: Participants are randomized and assigned to 75 mg of Pregabalin and 150 of Pregabalin groups in parallel for the duration of the studyParticipants are randomized and assigned to 75 mg of Pregabalin and 150 of Pregabalin groups in parallel for the duration of the study
• Masking: Double (Participant, Investigator)
• Primary Purpose: Treatment
• 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
• Actual Study Start Date: Jul 1, 2021
• Anticipated Primary Completion Date: Jan 1, 2024
• Anticipated Study Completion Date: Jan 1, 2024

Arms and Interventions

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

Outcome Measures

Primary Outcome Measures

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

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

Eligibility Criteria

Criteria

• Ages Eligible for Study: 55 Years to 80 Years
• Sexes Eligible for Study: All
• Accepts Healthy Volunteers: No

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

Contacts and Locations

Locations

	Site	City	State	Country	Postal Code
1	Thammasat University Hospital	Pathum Thani	Pathumthani	Thailand	12120

Sponsors and Collaborators

• Thammasat University

Investigators

None specified.

Study Documents (Full-Text)

None provided.

More Information

Publications

None provided.

• Responsible Party: Seksan Kukreja, Principal Investigator, Thammasat University
• ClinicalTrials.gov Identifier: NCT05447364
• Other Study ID Numbers: MTU-EC-OT-6-150/64
• First Posted: Jul 7, 2022
• Last Update Posted: Jul 7, 2022
• Last Verified: Jul 1, 2022

• Individual Participant Data (IPD) Sharing Statement: Yes
• Plan to Share IPD: Yes
• 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
• Keywords provided by Seksan Kukreja, Principal Investigator, Thammasat University: Total Knee Arthroplasty; Pregabalin
• Additional relevant MeSH terms: Osteoarthritis; Osteoarthritis, Knee; Pain, Postoperative; Pregabalin

Study Results

No Results Posted as of Jul 7, 2022