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

Sponsor

Prince of Songkla University (Other)

Overall Status

Completed

CT.gov ID

NCT01242332

Collaborator

(none)

Enrollment

Location

Arms

Duration (Months)

4.3

Patients Per Site Per Month

Study Details

Study Description

Brief Summary

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

Condition or Disease	Intervention/Treatment	Phase
Postoperative Pain Management	Drug: Pregabalin	Phase 4

Detailed Description

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

Study Design

Study Type:

Interventional

Actual Enrollment :

60 participants

Allocation:

Randomized

Intervention Model:

Parallel Assignment

Masking:

Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)

Primary Purpose:

Treatment

Official Title:

Perioperative Administration of Pregabalin in Patients Undergoing Arthroscopic Anterior Cruciate Ligament Reconstruction: Does it Help to Relieve Postoperative Pain?

Study Start Date :

Aug 1, 2009

Actual Primary Completion Date :

Oct 1, 2010

Actual Study Completion Date :

Oct 1, 2010

Arms and Interventions

Arm	Intervention/Treatment
No Intervention: placebo po 2 hrs before surgery
Experimental: Pregabalin 75 mg po 2 hrs before surgery	Drug: Pregabalin 75 mg po 2 hrs before surgery Other Names: Lyrica

Arm

Intervention/Treatment

No Intervention: placebo

po 2 hrs before surgery

Experimental: Pregabalin

75 mg po 2 hrs before surgery

Drug: Pregabalin

75 mg po 2 hrs before surgery

Other Names:

Lyrica

Outcome Measures

Primary Outcome Measures

efficacy [August 2009 - January 2011]
efficacy of postoperative pain management

Secondary Outcome Measures

safety [August 2009 - January 2011]
safety of pregabalin for postoperative pain management

Eligibility Criteria

Criteria

Ages Eligible for Study:

18 Years to 65 Years

Sexes Eligible for Study:

All

Accepts Healthy Volunteers:

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