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

NCT ID: NCT03211728

Last Updated: 2019-02-20

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

COMPLETED

Clinical Phase

NA

Total Enrollment

96 participants

Study Classification

INTERVENTIONAL

Study Start Date

2017-07-19

Study Completion Date

2019-02-08

Brief Summary

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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

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Conditions

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Anterior Cruciate Ligament (ACL) Reconstruction

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

Candidate for arthroscopic ACL reconstruction are divided into two groups of pregabalin and placebo with 48 patients in each group. The intervention group receive pregabalin 150 mg 1 hour before surgery and 12 hours after initial dose and a placebo is administered in control group.
Primary Study Purpose

PREVENTION

Blinding Strategy

QUADRUPLE

Participants Caregivers Investigators Outcome Assessors

Study Groups

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experimental group

Group Type EXPERIMENTAL

pregabalin

Intervention Type DRUG

The intervention group receive pregabalin 150 mg 1 hour before surgery and 12 hours after initial dose.

placebo group

Group Type PLACEBO_COMPARATOR

placebo

Intervention Type DRUG

The placebo group receive placebo 150 mg 1 hour before surgery and 12 hours after initial dose.

Interventions

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pregabalin

The intervention group receive pregabalin 150 mg 1 hour before surgery and 12 hours after initial dose.

Intervention Type DRUG

placebo

The placebo group receive placebo 150 mg 1 hour before surgery and 12 hours after initial dose.

Intervention Type DRUG

Eligibility Criteria

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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
Minimum Eligible Age

20 Years

Maximum Eligible Age

65 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No

Sponsors

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Yonsei University

OTHER

Sponsor Role lead

Responsible Party

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Responsibility Role SPONSOR

Locations

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

Seoul, , South Korea

Site Status

Countries

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South Korea

Other Identifiers

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4-2017-0415

Identifier Type: -

Identifier Source: org_study_id

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