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Clinical Trials/NCT01450345
NCT01450345UnknownPhase 3

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

University of Malaya1 site in 1 country72 target enrollmentStarted: September 2009Last updated:
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Conditions
Interventions
Drugs

Trial Snapshot

Phase
Phase 3
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.
Study OverviewStudy DesignEligibility CriteriaArms & InterventionsOutcomesInvestigatorsSitesRecords & IdentifiersSimilar Trials

Study 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.

Study Design

Study Type
Interventional
Allocation
Randomized
Intervention Model
Parallel
Primary Purpose
Prevention
Masking
Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)

Eligibility Criteria

Ages
12 Years to 75 Years (Child, Adult, Older Adult)
Sex
All
Accepts Healthy Volunteers
No

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

Experimental

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

Intervention: Pregabalin (Drug)

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)

Investigators

Sponsor Class
Other
Responsible Party
Principal Investigator
Principal Investigator

Toh Charng Chee

Principle Investigator

University of Malaya

Study Sites (1)

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Efficacy of Pre-operative Oral Pregabalin... | Clinical Trial