MedPath

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

Not Applicable
Completed
Conditions
Anterior Cruciate Ligament (ACL) Reconstruction
Interventions
Drug: placebo
Registration Number
NCT03211728
Lead Sponsor
Yonsei University
Brief Summary

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.

Detailed Description

Not available

Recruitment & Eligibility

Status
COMPLETED
Sex
All
Target Recruitment
96
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

Study & Design

Study Type
INTERVENTIONAL
Study Design
PARALLEL
Arm && Interventions
GroupInterventionDescription
experimental grouppregabalin-
placebo groupplacebo-
Primary Outcome Measures
NameTimeMethod
Postoperative pain scores2 weeks after surgery

Visual analog scale (VAS) score = 0-100 mm

Secondary Outcome Measures
NameTimeMethod
Opioid consumptionthe first 48 hours after surgery

Trial Locations

Locations (1)

Department of Anesthesiology and Pain Medicine, Anesthesia and Pain Research Institue, Yonsei Universiy College of Medicine

🇰🇷

Seoul, Korea, Republic of

© Copyright 2025. All Rights Reserved by MedPath