Efficacy of Pre-operative Oral Pregabalin in Ambulatory Inguinal Hernia Repair for Post Operative Pain
Information source: University of Malaya
Information obtained from ClinicalTrials.gov on February 07, 2013
Link to the current ClinicalTrials.gov record.
Condition(s) targeted: Inguinal Hernia; Postoperative Pain
Intervention: Pregabalin (Drug)
Phase: Phase 3
Status: Recruiting
Sponsored by: University of Malaya Official(s) and/or principal investigator(s):
CharngChee Toh, MBBS, MRCS, Principal Investigator, Affiliation: University Malaya
Overall contact:
CharngChee Toh, MBBS, MRCS, Phone: 60193380337, Email: toh2c79@yahoo.com
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.
Clinical Details
Official title: Efficacy of Pre-operative Oral Pregabalin in Ambulatory Inguinal Hernia Repair for Post Operative Pain
Study design: Allocation: Randomized, Endpoint Classification: Safety/Efficacy Study, Intervention Model: Parallel Assignment, Masking: Double Blind (Subject, Caregiver, Investigator, Outcomes Assessor), Primary Purpose: Prevention
Primary outcome: 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.
Secondary outcome: Opiod SparingSide effect of medication
Eligibility
Minimum age: 12 Years.
Maximum age: 75 Years.
Gender(s): Both.
Criteria:
Inclusion Criteria:
- Clinical diagnosis of inguinal hernia
- Patient undergo operation under daycare basis
- ASA I-II
- 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
Locations and Contacts
CharngChee Toh, MBBS, MRCS, Phone: 60193380337, Email: toh2c79@yahoo.com
University Malaya, Kuala Lumpur 59100, Malaysia; Recruiting
CharngChee Toh, MBBS, MRCS, Phone: 60193380337, Email: toh2c79@yahoo.com
CharngChee Toh, MBBS, MRCS, Principal Investigator
Additional Information
Starting date: September 2009
Last updated: October 11, 2011
|
