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CompletedNCT01242332Updated Nov 17, 2010

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

A Phase 4 interventional study of Pregabalin in Postoperative Pain Management, sponsored by Prince of Songkla University. Completed at 1 site in Thailand. Open to participants aged 18 Years to 65 Years. Per ClinicalTrials.gov, last updated 2010-11-17.

Sponsored by Prince of Songkla University · Phase 4, Interventional, and Treatment

Phase
Phase 4
Study type
Interventional
Enrollment
60
Allocation
Randomized
Ages
18 Years to 65 Years
Sex
All
01

Study summary

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

Read the 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
02

Conditions studied

  • Postoperative Pain Management

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Keywords

  • perioperative
  • pregabalin
  • arthroscopic anterior cruciate ligament reconstruction
  • postoperative pain management
03

In context

Pain, Postoperative

5,093 studies on the registry are indexed under Pain, Postoperative; 1,140 are open to participants now.

This study's enrollment of 60 is below the median of 75 across 4,344 interventional studies indexed under Pain, Postoperative.

Browse Pain, Postoperative studies →

Lead sponsor

Prince of Songkla University is the lead sponsor of 112 studies on the registry; 13 are open to participants now.

Counted across the registry records on this site, refreshed daily.

04

Who can participate

Ages eligible
18 Years to 65 Years
Sexes eligible
All
Accepts healthy volunteers
No

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

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
05

Study design

Phase
Phase 4
Primary purpose
Treatment
Allocation
Randomized
Intervention model
Parallel assignment
Masking
Quadruple (Participant, Care provider, Investigator, Outcomes assessor)
Enrollment
60 participants (actual)

Study arms

  • No intervention
    placebo

    po 2 hrs before surgery

  • Experimental
    Pregabalin

    75 mg po 2 hrs before surgery

    Drug: Pregabalin

Interventions

  • DrugPregabalin

    75 mg po 2 hrs before surgery

    Also known as: Lyrica

06

What researchers measure

Primary outcomes

  1. efficacy

    efficacy of postoperative pain management

    Time frame: August 2009 - January 2011

Secondary outcomes

  1. safety

    safety of pregabalin for postoperative pain management

    Time frame: August 2009 - January 2011

07

Study locations

1 site
  • Faculty of Medicine, Prince of Songkla University
    Hatyai, Songkhla 90110, Thailand
08

References and documents

Publications

  • 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. PubMed 19641054 ↗
09

Updates

Tracking since Sep 25, 2026
No changes since tracking began. The registry record was last updated on Nov 17, 2010, before this site started recording changes on Sep 25, 2026. Its history is on ClinicalTrials.gov ↗
10

Registry details

Key details

Study ID
NCT01242332
Lead sponsor
Prince of Songkla University
First posted
Nov 17, 2010
Start date
Aug 2009
Primary completion
Oct 2010
Completion
Oct 2010
Last update
Nov 17, 2010

Study contacts

Sasikaan Nimmaanrat, MD, MMed
principal investigator · Department of Anesthesiology, Faculty of Medicine, Prince of Songkla University

Oversight

Data monitoring committee
Yes
View the source record on ClinicalTrials.gov ↗

Not currently enrolling

This study is completed, as verified in May 2009. You cannot join it, but the record below documents what was studied.

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Discussion

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