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

Knee Osteoarthritis Clinical Trial

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT05447364
• Other study ID #: MTU-EC-OT-6-150/64
• Status: Completed
• Phase: Phase 4
• Start date: July 1, 2021
• Est. completion date: March 1, 2024

Study information

• Verified date: April 2024
• Source: Thammasat University
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical 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.

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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 82
• Est. completion date: March 1, 2024
• Est. primary completion date: September 1, 2023
• Accepts healthy volunteers: No
• Gender: All
• Age group: 55 Years to 80 Years

Eligibility

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

Related Conditions & MeSH terms

• Knee Osteoarthritis
• Osteoarthritis
• Osteoarthritis, Knee
• Pain, Postoperative

Intervention

Drug:
• Pregabalin 75mg
1 tab of Pregabalin Brillior 75 mg and 1 tab of Placebo
• Pregabalin 150mg
2 tabs of Pregabalin Brillior 75 mg

Locations

Country	Name	City	State
Thailand	Thammasat University Hospital	Pathum Thani	Pathumthani

Sponsors (1)

Lead Sponsor	Collaborator
Thammasat University

Country where clinical trial is conducted

Thailand, 

References & Publications (11)

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 — View Citation

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 2 — View Citation

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.0b — View 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. — View 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. — View Citation

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. — View Citation

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. — View Citation

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. — View 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. — View Citation

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 — View Citation

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-control — View Citation

* Note: There are 11 references in all — Click here to view all references

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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	6, 12, 18, 24, 48 hours & 2, 6, 12 weeks after surgery
Secondary	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	From postoperative period until 48 hours after surgery
Secondary	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	6, 12, 18, 24, 48 hours & 2, 6, 12 weeks after surgery
Secondary	Difference on length of stay between 75 mg of Pregabalin and 150 mg of Pregabalin groups	Time to discharge	From postoperative period until 48 hours after surgery
Secondary	Difference on time to ambulation between 75 mg of Pregabalin and 150 mg of Pregabalin groups	Time from operation to ambulation before hospital discharge	From postoperative period until 48 hours after surgery
Secondary	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	2, 6, 12 weeks after surgery
Secondary	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	2, 6, 12 weeks after surgery
Secondary	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	2, 6, 12 weeks after surgery
Secondary	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.	2, 6, 12 weeks after surgery
Secondary	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.	2, 6, 12 weeks after surgery