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

Postoperative Pain Management Clinical Trial

Official title:

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT01242332
• Other study ID #: EC 52 -234-08-1-2
• Status: Completed
• Phase: Phase 4
• First received: November 16, 2010
• Last updated: November 16, 2010
• Start date: August 2009
• Est. completion date: October 2010

Study information

• Verified date: May 2009
• Source: Prince of Songkla University
• Contact: n/a
• Is FDA regulated: No
• Health authority: Thailand: Food and Drug Administration
• Study type: Interventional

Clinical Trial Summary

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

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

Recruitment information / eligibility

• Status: Completed
• Enrollment: 60
• Est. completion date: October 2010
• Est. primary completion date: October 2010
• Accepts healthy volunteers: No
• Gender: Both
• Age group: 18 Years to 65 Years

Eligibility

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

Study Design

Allocation: Randomized, Endpoint Classification: Safety/Efficacy Study, Intervention Model: Parallel Assignment, Masking: Double Blind (Subject, Caregiver, Investigator, Outcomes Assessor), Primary Purpose: Treatment

Related Conditions & MeSH terms

• Pain, Postoperative
• Postoperative Pain Management

Intervention

Drug:
• Pregabalin
75 mg po 2 hrs before surgery

Locations

Country	Name	City	State
Thailand	Faculty of Medicine, Prince of Songkla University	Hatyai	Songkhla

Sponsors (1)

Lead Sponsor	Collaborator
Prince of Songkla University

Country where clinical trial is conducted

Thailand, 

References & Publications (1)

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. — View Citation

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	efficacy	efficacy of postoperative pain management	August 2009 - January 2011	Yes
Secondary	safety	safety of pregabalin for postoperative pain management	August 2009 - January 2011	Yes