- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT01450345
Efficacy of Pre-operative Oral Pregabalin in Ambulatory Inguinal Hernia Repair for Post Operative Pain
October 11, 2011 updated by: Toh Charng Chee, University of Malaya
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 Overview
Status
Unknown
Conditions
Intervention / Treatment
Study Type
Interventional
Enrollment (Anticipated)
72
Phase
- Phase 3
Contacts and Locations
This section provides the contact details for those conducting the study, and information on where this study is being conducted.
Study Contact
- Name: CharngChee Toh, MBBS, MRCS
- Phone Number: 60193380337
- Email: toh2c79@yahoo.com
Study Locations
-
-
-
Kuala Lumpur, Malaysia, 59100
- Recruiting
- University Malaya
-
Contact:
- CharngChee Toh, MBBS, MRCS
- Phone Number: 60193380337
- Email: toh2c79@yahoo.com
-
Principal Investigator:
- CharngChee Toh, MBBS, MRCS
-
-
Participation Criteria
Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.
Eligibility Criteria
Ages Eligible for Study
12 years to 75 years (Child, Adult, Older Adult)
Accepts Healthy Volunteers
No
Genders Eligible for Study
All
Description
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
Study Plan
This section provides details of the study plan, including how the study is designed and what the study is measuring.
How is the study designed?
Design Details
- Primary Purpose: Prevention
- Allocation: Randomized
- Interventional Model: Parallel Assignment
- Masking: Quadruple
Arms and Interventions
Participant Group / Arm |
Intervention / Treatment |
---|---|
Experimental: Pregabalin Group
The patient under Group P will be serving with 150 mg of oral Pregabalin 1 to 2 hours prior to induction.
|
The patient under Group P will be serving with 150 mg of oral Pregabalin 1 to 2 hours prior to induction.
Other Names:
|
What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
---|---|---|
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.
|
3 days
|
Secondary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
---|---|---|
Opiod Sparing
Time Frame: 3 days
|
Total amount of rescue medication requires
|
3 days
|
Side effect of medication
Time Frame: 3 days
|
Severity of Post operative nausea and vomiting (PONV) graded with mild, moderare and severe(Vomiting) Side effect of medication includes headache, giddiness, visual disturbance, and difficulty in walking.
|
3 days
|
Collaborators and Investigators
This is where you will find people and organizations involved with this study.
Sponsor
Investigators
- Principal Investigator: CharngChee Toh, MBBS, MRCS, University Malaya
Study record dates
These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.
Study Major Dates
Study Start
September 1, 2009
Primary Completion (Anticipated)
December 1, 2011
Study Completion (Anticipated)
December 1, 2011
Study Registration Dates
First Submitted
September 24, 2011
First Submitted That Met QC Criteria
October 11, 2011
First Posted (Estimate)
October 12, 2011
Study Record Updates
Last Update Posted (Estimate)
October 12, 2011
Last Update Submitted That Met QC Criteria
October 11, 2011
Last Verified
October 1, 2011
More Information
Terms related to this study
Keywords
Additional Relevant MeSH Terms
- Pathologic Processes
- Postoperative Complications
- Pain
- Neurologic Manifestations
- Pathological Conditions, Anatomical
- Hernia, Abdominal
- Pain, Postoperative
- Hernia
- Hernia, Inguinal
- Physiological Effects of Drugs
- Molecular Mechanisms of Pharmacological Action
- Central Nervous System Depressants
- Peripheral Nervous System Agents
- Analgesics
- Sensory System Agents
- Tranquilizing Agents
- Psychotropic Drugs
- Membrane Transport Modulators
- Anti-Anxiety Agents
- Anticonvulsants
- Calcium-Regulating Hormones and Agents
- Calcium Channel Blockers
- Pregabalin
Other Study ID Numbers
- toh2c79@Pregabalin
This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.
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