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

P

Prince of Songkla University

Status and phase

Completed
Phase 4

Conditions

Postoperative Pain Management

Treatments

Drug: Pregabalin

Study type

Interventional

Funder types

Other

Identifiers

NCT01242332
EC 52 -234-08-1-2

Details and patient eligibility

About

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

Full 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

Enrollment

60 patients

Sex

All

Ages

18 to 65 years old

Volunteers

No 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

Trial design

Primary purpose

Treatment

Allocation

Randomized

Interventional model

Parallel Assignment

Masking

Quadruple Blind

60 participants in 2 patient groups

placebo
No Intervention group
Description:
po 2 hrs before surgery
Pregabalin
Experimental group
Description:
75 mg po 2 hrs before surgery
Treatment:
Drug: Pregabalin

Trial contacts and locations

1

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Data sourced from clinicaltrials.gov

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