Perioperative Administration of Pregabalin in Patients Undergoing Arthroscopic Anterior Cruciate Ligament Reconstruction

NCT ID: NCT01242332

Last Updated: 2010-11-17

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

PHASE4

Total Enrollment

60 participants

Study Classification

INTERVENTIONAL

Study Start Date

2009-08-31

Study Completion Date

2010-10-31

Brief Summary

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To prove pregabalin's efficacy and safety in Thai patients scheduled for arthroscopic ACL reconstruction

Detailed Description

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Only eligible patients with willingness to join this study are included. Eligible patients are those aged 18-65 years of either sex, American Society of Anesthesiologists (ASA) physical status I \& II, and body mass index (BMI) between 16-35. The exclusion criteria are patients who are allergic to pregabalin, with impaired hepatic and renal functions, alcohol or substance abuse, chronic pain (except pain in the knee joint) or daily intake of analgesics, uncontrolled medical disease (hypertension and diabetes mellitus) and inability to operate patient-controlled analgesia (PCA) device.

Data analysis

* Student t-test for continuous data with normal distribution
* Mann-Whitney U test for continuous data with non-normal distribution
* Chi-square test for categorical data

Conditions

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Postoperative Pain Management

Keywords

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perioperative pregabalin arthroscopic anterior cruciate ligament reconstruction postoperative pain management

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

Primary Study Purpose

TREATMENT

Blinding Strategy

QUADRUPLE

Participants Caregivers Investigators Outcome Assessors

Study Groups

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placebo

po 2 hrs before surgery

Group Type NO_INTERVENTION

No interventions assigned to this group

Pregabalin

75 mg po 2 hrs before surgery

Group Type EXPERIMENTAL

Pregabalin

Intervention Type DRUG

75 mg po 2 hrs before surgery

Interventions

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Pregabalin

75 mg po 2 hrs before surgery

Intervention Type DRUG

Other Intervention Names

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Lyrica

Eligibility Criteria

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Inclusion Criteria

* Eligible patients are those aged 18-65 years of either sex,
* American Society of Anesthesiologists (ASA) physical status I \& II, and body mass index (BMI) between 16-35.

Exclusion Criteria

* patients who are allergic to pregabalin,
* impaired hepatic and renal functions,
* alcohol or substance abuse,
* chronic pain (except pain in the knee joint) or daily intake of analgesics, uncontrolled medical disease (hypertension and diabetes mellitus)
* inability to operate patient-controlled analgesia (PCA) device
Minimum Eligible Age

18 Years

Maximum Eligible Age

65 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No

Sponsors

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Prince of Songkla University

OTHER

Sponsor Role lead

Responsible Party

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Deparment of Anesthesiology, Faculty of Medicine, Prince of Songkla University

Principal Investigators

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Sasikaan Nimmaanrat, MD, MMed

Role: PRINCIPAL_INVESTIGATOR

Department of Anesthesiology, Faculty of Medicine, Prince of Songkla University

Locations

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Faculty of Medicine, Prince of Songkla University

Hat Yai, Changwat Songkhla, Thailand

Site Status

Countries

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Thailand

References

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Chang SH, Lee HW, Kim HK, Kim SH, Kim DK. An evaluation of perioperative pregabalin for prevention and attenuation of postoperative shoulder pain after laparoscopic cholecystectomy. Anesth Analg. 2009 Oct;109(4):1284-6. doi: 10.1213/ane.0b013e3181b4874d. Epub 2009 Jul 29.

Reference Type RESULT
PMID: 19641054 (View on PubMed)

Other Identifiers

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EC 52 -234-08-1-2

Identifier Type: -

Identifier Source: org_study_id