Efficacy of Pre-operative Oral Pregabalin in Ambulatory Inguinal Hernia Repair for Post Operative Pain
1 other identifier
interventional
72
1 country
1
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.
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at below P25 for phase_3
Started Sep 2009
1 active site
Health score is calculated from publicly available data and should be used for screening purposes only.
Trial Relationships
Click on a node to explore related trials.
Study Timeline
Key milestones and dates
Study Start
First participant enrolled
September 1, 2009
CompletedFirst Submitted
Initial submission to the registry
September 24, 2011
CompletedFirst Posted
Study publicly available on registry
October 12, 2011
CompletedPrimary Completion
Last participant's last visit for primary outcome
December 1, 2011
CompletedStudy Completion
Last participant's last visit for all outcomes
December 1, 2011
CompletedOctober 12, 2011
October 1, 2011
2.2 years
September 24, 2011
October 11, 2011
Conditions
Keywords
Outcome Measures
Primary Outcomes (1)
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.
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.
3 days
Secondary Outcomes (2)
Opiod Sparing
3 days
Side effect of medication
3 days
Study Arms (1)
Pregabalin Group
EXPERIMENTALThe patient under Group P will be serving with 150 mg of oral Pregabalin 1 to 2 hours prior to induction.
Interventions
The patient under Group P will be serving with 150 mg of oral Pregabalin 1 to 2 hours prior to induction.
Eligibility Criteria
You may qualify if:
- Clinical diagnosis of inguinal hernia
- Patient undergo operation under daycare basis
- ASA I-II
- Written consent
You may not qualify if:
- 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
Contact the study team to confirm eligibility.
Sponsors & Collaborators
Study Sites (1)
University Malaya
Kuala Lumpur, Kuala Lumpur, 59100, Malaysia
MeSH Terms
Conditions
Interventions
Condition Hierarchy (Ancestors)
Intervention Hierarchy (Ancestors)
Study Officials
- PRINCIPAL INVESTIGATOR
CharngChee Toh, MBBS, MRCS
University of Malaya
Central Study Contacts
Study Design
- Study Type
- interventional
- Phase
- phase 3
- Allocation
- RANDOMIZED
- Masking
- QUADRUPLE
- Who Masked
- PARTICIPANT, CARE PROVIDER, INVESTIGATOR, OUTCOMES ASSESSOR
- Purpose
- PREVENTION
- Intervention Model
- PARALLEL
- Sponsor Type
- OTHER
- Responsible Party
- PRINCIPAL INVESTIGATOR
- PI Title
- Principle Investigator
Study Record Dates
First Submitted
September 24, 2011
First Posted
October 12, 2011
Study Start
September 1, 2009
Primary Completion
December 1, 2011
Study Completion
December 1, 2011
Last Updated
October 12, 2011
Record last verified: 2011-10