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Completed

NCT Number: NCT01242332

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

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

Completed

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Key information

Conditions

Postoperative Pain Management

Age range

18 year–65 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Phase 4

Primary location

Faculty of Medicine, Prince of Songkla University

Hat Yai, Changwat Songkhla, 90110, Thailand

About this study

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

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

Pregabalin

Drug

75 mg po 2 hrs before surgery

Other names: Lyrica

Primary outcomes

  1. efficacy

    Time frame: August 2009 - January 2011

    efficacy of postoperative pain management

Secondary outcomes

  1. safety

    Time frame: August 2009 - January 2011

    safety of pregabalin for postoperative pain management

Sponsors and collaborators

Lead sponsor

Prince of Songkla University

Other

Registry information

Official study title

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

Important dates

Study start
2009
Primary completion
2010
Study completion
2010
First posted
Nov 17, 2010
Registry last updated
Nov 17, 2010

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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