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

This study has been completed.
Sponsor:
Information provided by:
Prince of Songkla University
ClinicalTrials.gov Identifier:
NCT01242332
First received: November 16, 2010
Last updated: NA
Last verified: May 2009
History: No changes posted
  Purpose

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


Condition Intervention Phase
Postoperative Pain Management
Drug: Pregabalin
Phase 4

Study Type: Interventional
Study Design: Allocation: Randomized
Endpoint Classification: Safety/Efficacy Study
Intervention Model: Parallel Assignment
Masking: Double Blind (Subject, Caregiver, 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?

Resource links provided by NLM:


Further study details as provided by Prince of Songkla University:

Primary Outcome Measures:
  • efficacy [ Time Frame: August 2009 - January 2011 ] [ Designated as safety issue: Yes ]
    efficacy of postoperative pain management


Secondary Outcome Measures:
  • safety [ Time Frame: August 2009 - January 2011 ] [ Designated as safety issue: Yes ]
    safety of pregabalin for postoperative pain management


Enrollment: 60
Study Start Date: August 2009
Study Completion Date: October 2010
Primary Completion Date: October 2010 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
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 Name: Lyrica

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
  Eligibility

Ages Eligible for Study:   18 Years to 65 Years
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No
Criteria

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
  Contacts and Locations
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT01242332

Locations
Thailand
Faculty of Medicine, Prince of Songkla University
Hatyai, Songkhla, Thailand, 90110
Sponsors and Collaborators
Prince of Songkla University
Investigators
Principal Investigator: Sasikaan Nimmaanrat, MD, MMed Department of Anesthesiology, Faculty of Medicine, Prince of Songkla University
  More Information

Publications:
Responsible Party: Sasikaan Nimmaanrat, Dr. (MD), Deparment of Anesthesiology, Faculty of Medicine, Prince of Songkla University
ClinicalTrials.gov Identifier: NCT01242332     History of Changes
Other Study ID Numbers: EC 52 -234-08-1-2
Study First Received: November 16, 2010
Last Updated: November 16, 2010
Health Authority: Thailand: Food and Drug Administration

Keywords provided by Prince of Songkla University:
perioperative
pregabalin
arthroscopic anterior cruciate ligament reconstruction
postoperative pain management

Additional relevant MeSH terms:
Pain, Postoperative
Pain
Pathologic Processes
Postoperative Complications
Signs and Symptoms
Pregabalin
Analgesics
Anticonvulsants
Calcium Channel Blockers
Cardiovascular Agents
Central Nervous System Agents
Membrane Transport Modulators
Molecular Mechanisms of Pharmacological Action
Peripheral Nervous System Agents
Pharmacologic Actions
Physiological Effects of Drugs
Sensory System Agents
Therapeutic Uses

ClinicalTrials.gov processed this record on October 23, 2014