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

February 19, 2019 updated by: Yonsei University
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.

Study Overview

Status

Completed

Conditions

Intervention / Treatment

Study Type

Interventional

Enrollment (Actual)

96

Phase

  • Not Applicable

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • Korea, Republic of
      • Seoul, Korea, Republic of, 03722
        • Department of Anesthesiology and Pain Medicine, Anesthesia and Pain Research Institue, Yonsei Universiy College of Medicine

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

20 years to 65 years (Adult, Older Adult)

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Description

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 Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Prevention
  • Allocation: Randomized
  • Interventional Model: Parallel Assignment
  • Masking: Quadruple

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
Experimental: experimental group
Drug: pregabalin
The intervention group receive pregabalin 150 mg 1 hour before surgery and 12 hours after initial dose.
Placebo Comparator: placebo group
Drug: placebo
The placebo group receive placebo 150 mg 1 hour before surgery and 12 hours after initial dose.

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Postoperative pain scores
Time Frame: 12 hours after surgery
Visual analog scale (VAS) score = 0-100 mm
12 hours after surgery
Postoperative pain scores
Time Frame: 24 hours after surgery
Visual analog scale (VAS) score = 0-100 mm
24 hours after surgery
Postoperative pain scores
Time Frame: 36 hours after surgery
Visual analog scale (VAS) score = 0-100 mm
36 hours after surgery
Postoperative pain scores
Time Frame: 2 weeks after surgery
Visual analog scale (VAS) score = 0-100 mm
2 weeks after surgery

Secondary Outcome Measures

Outcome Measure
Time Frame
Opioid consumption
Time Frame: the first 48 hours after surgery
the first 48 hours after surgery

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Yonsei University

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

July 19, 2017

Primary Completion (Actual)

February 8, 2019

Study Completion (Actual)

February 8, 2019

Study Registration Dates

First Submitted

July 6, 2017

First Submitted That Met QC Criteria

July 6, 2017

First Posted (Actual)

July 7, 2017

Study Record Updates

Last Update Posted (Actual)

February 20, 2019

Last Update Submitted That Met QC Criteria

February 19, 2019

Last Verified

February 1, 2019

More Information

Terms related to this study

Additional Relevant MeSH Terms

Other Study ID Numbers

  • 4-2017-0415

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

NO

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

Clinical Trials on Anterior Cruciate Ligament (ACL) Reconstruction

Clinical Trials on pregabalin

Search Similar Trials

Sponsors and Collaborators

Medical Conditions

Drug Interventions

CROs by country

CROs in Liberia

Conditions

Rare Diseases

Drug Interventions

Dietary Supplements

Sponsor/Collaborators

Locations

Subscribe