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Clinical Trials/NCT03211728
NCT03211728
Completed
Not Applicable

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

Yonsei University1 site in 1 country96 target enrollmentJuly 19, 2017

Overview

Phase
Not Applicable
Intervention
pregabalin
Conditions
Anterior Cruciate Ligament (ACL) Reconstruction
Sponsor
Yonsei University
Enrollment
96
Locations
1
Primary Endpoint
Postoperative pain scores
Status
Completed
Last Updated
7 years ago

Overview

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.

Registry
clinicaltrials.gov
Start Date
July 19, 2017
End Date
February 8, 2019
Last Updated
7 years ago
Study Type
Interventional
Study Design
Parallel
Sex
All

Investigators

Responsible Party
Sponsor

Eligibility Criteria

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

Arms & Interventions

experimental group

Intervention: pregabalin

placebo group

Intervention: placebo

Outcomes

Primary Outcomes

Postoperative pain scores

Time Frame: 2 weeks after surgery

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

Secondary Outcomes

  • Opioid consumption(the first 48 hours after surgery)

Study Sites (1)

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