NCT01242332

Brief Summary

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

Trial Health

87
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
60

participants targeted

Target at P25-P50 for phase_4

Timeline
Completed

Started Aug 2009

Geographic Reach
1 country

1 active site

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Start

First participant enrolled

August 1, 2009

Completed
1.2 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

October 1, 2010

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

October 1, 2010

Completed
2 months until next milestone

First Submitted

Initial submission to the registry

November 16, 2010

Completed
1 day until next milestone

First Posted

Study publicly available on registry

November 17, 2010

Completed
Last Updated

November 17, 2010

Status Verified

May 1, 2009

Enrollment Period

1.2 years

First QC Date

November 16, 2010

Last Update Submit

November 16, 2010

Conditions

Postoperative Pain Management

Keywords

perioperativepregabalinarthroscopic anterior cruciate ligament reconstructionpostoperative pain management

Outcome Measures

Primary Outcomes (1)

  • efficacy

    efficacy of postoperative pain management

    August 2009 - January 2011

Secondary Outcomes (1)

  • safety

    August 2009 - January 2011

Study Arms (2)

placebo

NO INTERVENTION

po 2 hrs before surgery

Pregabalin

EXPERIMENTAL

75 mg po 2 hrs before surgery

Drug: Pregabalin

Interventions

PregabalinDRUG

75 mg po 2 hrs before surgery

Also known as: Lyrica
Pregabalin

Eligibility Criteria

Age18 Years - 65 Years
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • 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.

You may not qualify if:

  • 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

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Faculty of Medicine, Prince of Songkla University

Hat Yai, Changwat Songkhla, 90110, Thailand

Location

Related 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. Epub 2009 Jul 29.

    PMID: 19641054RESULT

MeSH Terms

Interventions

Pregabalin

Intervention Hierarchy (Ancestors)

gamma-Aminobutyric AcidAminobutyratesButyratesAcids, AcyclicCarboxylic AcidsOrganic ChemicalsAmino AcidsAmino Acids, Peptides, and Proteins

Study Officials

  • Sasikaan Nimmaanrat, MD, MMed

    Department of Anesthesiology, Faculty of Medicine, Prince of Songkla University

    PRINCIPAL INVESTIGATOR

Study Design

Study Type
interventional
Phase
phase 4
Allocation
RANDOMIZED
Masking
QUADRUPLE
Who Masked
PARTICIPANT, CARE PROVIDER, INVESTIGATOR, OUTCOMES ASSESSOR
Purpose
TREATMENT
Intervention Model
PARALLEL
Sponsor Type
OTHER

Study Record Dates

First Submitted

November 16, 2010

First Posted

November 17, 2010

Study Start

August 1, 2009

Primary Completion

October 1, 2010

Study Completion

October 1, 2010

Last Updated

November 17, 2010

Record last verified: 2009-05

Locations

TH(1)