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Clinical Trials/NCT01450345
NCT01450345
Unknown
Phase 3

Efficacy of Pre-operative Oral Pregabalin in Ambulatory Inguinal Hernia Repair for Post Operative Pain

University of Malaya1 site in 1 country72 target enrollmentSeptember 2009

Overview

Phase
Phase 3
Intervention
Pregabalin
Conditions
Inguinal Hernia
Sponsor
University of Malaya
Enrollment
72
Locations
1
Primary Endpoint
Study is constructed to determine whether the use of oral pregabalin premedication to assess the analgesic efficacy for post operative pain at Alert, 15, 30, 45, 60 and 120 min, Day 1, Day 2 and Day 3.
Last Updated
14 years ago

Overview

Brief Summary

The study carry out is to determine whether the use of oral pregabalin premedication to assess the analgesic efficacy, opiod sparing, adverse effect and clinical value in post-operative pain management.

Registry
clinicaltrials.gov
Start Date
September 2009
End Date
December 2011
Last Updated
14 years ago
Study Type
Interventional
Study Design
Parallel
Sex
All

Investigators

Responsible Party
Principal Investigator
Principal Investigator

Toh Charng Chee

Principle Investigator

University of Malaya

Eligibility Criteria

Inclusion Criteria

  • Clinical diagnosis of inguinal hernia
  • Patient undergo operation under daycare basis
  • Written consent

Exclusion Criteria

  • ASA \> II
  • Allergic reaction against gabapentin and/or pregabalin
  • History of recurrent hernia repair.
  • Patient who has taken analgesia prior to the surgery
  • Liver failure
  • Renal failure
  • Pregnancy

Arms & Interventions

Pregabalin Group

The patient under Group P will be serving with 150 mg of oral Pregabalin 1 to 2 hours prior to induction.

Intervention: Pregabalin

Outcomes

Primary Outcomes

Study is constructed to determine whether the use of oral pregabalin premedication to assess the analgesic efficacy for post operative pain at Alert, 15, 30, 45, 60 and 120 min, Day 1, Day 2 and Day 3.

Time Frame: 3 days

Efficacy: To compare the VAS score for pain after operation between the group at Alert, 15, 30, 45, 60 and 120 min, Day 1, Day 2 and Day 3.

Secondary Outcomes

  • Opiod Sparing(3 days)
  • Side effect of medication(3 days)

Study Sites (1)

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