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

Thammasat University

Status and phase: Completed; Phase 4

Conditions: Knee Osteoarthritis

Treatments: Drug: Pregabalin 150mg; Drug: Pregabalin 75mg

Study type: Interventional

Funder types: Other

Identifiers

NCT05447364

MTU-EC-OT-6-150/64

Details and patient eligibility

About

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.

Full 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.

Enrollment: 82 patients

Sex: All

Ages: 55 to 80 years old

Volunteers: No 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

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: Double Blind

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82 participants in 2 patient groups

75 mg of Pregabalin

Experimental group

Description:

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

Treatment:

Drug: Pregabalin 75mg

150 mg of Pregabalin

Active Comparator group

Description:

Participant received 2 tabs of 75 mg of Pregabalin

Treatment:

Drug: Pregabalin 150mg