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

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

Status

Completed

Phases

Phase 4

Study type

Interventional

Source

ClinicalTrials.gov

Registry ID

NCT01242332

Enrollment

Registered

2010-11-17

Start date

2009-08-31

Completion date

2010-10-31

Last updated

2010-11-17

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Postoperative Pain Management

Keywords

perioperative, pregabalin, arthroscopic anterior cruciate ligament reconstruction, postoperative pain management

Brief summary

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

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

Interventions

DRUGPregabalin

75 mg po 2 hrs before surgery

Study design

Allocation

RANDOMIZED

Intervention model

PARALLEL

Primary purpose

TREATMENT

Masking

QUADRUPLE (Subject, Caregiver, Investigator, Outcomes Assessor)

Eligibility

Sex/Gender

ALL

Age

18 Years to 65 Years

Healthy volunteers

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

Design outcomes

Primary

Measure	Time frame	Description
efficacy	August 2009 - January 2011	efficacy of postoperative pain management

Secondary

Measure	Time frame	Description
safety	August 2009 - January 2011	safety of pregabalin for postoperative pain management

Countries

Thailand

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Feb 4, 2026