Does Perioperative Pregabalin Reduce Postoperative Pain After Arthroscopic Anterior Cruciate Ligament Reconstruction Surgery Under Spinal Anesthesia?

Yonsei University

Status: Completed

Conditions: Anterior Cruciate Ligament (ACL) Reconstruction

Treatments: Drug: placebo; Drug: pregabalin

Study type: Interventional

Funder types: Other

Identifiers

NCT03211728

4-2017-0415

Details and patient eligibility

About

The investigators hypothesize that perioperative oral administration of pregabalin would reduce postoperative pain and produce reduction in postoperative opioid consumption after anterior cruciate ligament (ACL) reconstruction . Patients are randomly assign to 1 of 2 groups. The placebo group receive placebo capsules 1 hour before surgery and 12 hours after initial dose. The pregabalin group receive pregabalin 150 mg, respectively at the same points.

Enrollment: 96 patients

Sex: All

Ages: 20 to 65 years old

Volunteers: No Healthy Volunteers

Inclusion criteria

• age between 20-65 years
• physical condition type I or II in ASA (American Society of Anesthesiology)

Exclusion criteria

• patients of ASA classification 3 or more
• with a history of cardiovascular or respiratory disease
• dizziness or frequent headache
• active alcohol or drug usage,
• intake of any analgesics daily or 48 hours before surgery
• impaired renal and/or hepatic function

Trial design

Primary purpose: Prevention

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: Quadruple Blind

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96 participants in 2 patient groups, including a placebo group

experimental group

Experimental group

Treatment:

Drug: pregabalin

placebo group

Placebo Comparator group

Treatment:

Drug: placebo