Study Stopped
Changes to surgical practices led to the loss of eligible patients
Post-Operative Pain Scores and Analgesic Requirements After Elective Inguinal Herniorrhaphy
An Investigation of Post-Operative Pain Scores and Analgesic Requirements After Ambulatory Inguinal Herniorrhaphy With Pre-Operative Gabapentin Therapy
1 other identifier
interventional
5
1 country
1
Brief Summary
The study will investigate the effects of single dose pre-operative oral dose of gabapentin (1200) on post -operative pain scores and oral analgesic requirements.
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at below P25 for phase_2 pain
Started Nov 2008
1 active site
Health score is calculated from publicly available data and should be used for screening purposes only.
Trial Relationships
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Study Timeline
Key milestones and dates
First Submitted
Initial submission to the registry
August 13, 2008
CompletedFirst Posted
Study publicly available on registry
August 14, 2008
CompletedStudy Start
First participant enrolled
November 6, 2008
CompletedPrimary Completion
Last participant's last visit for primary outcome
September 1, 2009
CompletedStudy Completion
Last participant's last visit for all outcomes
September 1, 2009
CompletedApril 28, 2017
April 1, 2017
10 months
August 13, 2008
April 26, 2017
Conditions
Keywords
Outcome Measures
Primary Outcomes (1)
Post operative pain is reduced when single pre-operative oral dose of Gabapentine is given to the patient before the Inguinal Herniorrhaphy
Post operative pain is reduced when single pre-operative oral dose of
1yrs
Secondary Outcomes (1)
The post operative analgesia requirement is also reduced
1yrs
Study Arms (2)
Single pre-op dose of Gabapentine
ACTIVE COMPARATORActive treatment with the study drug
Placebo
PLACEBO COMPARATORPlacebo arm for blinding the medication
Interventions
1200 mg single dose gabapentin
Eligibility Criteria
You may qualify if:
- Subjects having elective surgery with open unilateral Inguinal herniorraphy
You may not qualify if:
- Non elective surgery
- Patients currently on gabapentin therapy
- Patient hypersensitive to gabapentin surgery
- History of alcohol or drug abuse
- Patients who are pregnant or who are nursing
Contact the study team to confirm eligibility.
Sponsors & Collaborators
Study Sites (1)
OUHSC
Oklahoma City, Oklahoma, 73152, United States
MeSH Terms
Conditions
Interventions
Condition Hierarchy (Ancestors)
Intervention Hierarchy (Ancestors)
Study Officials
- PRINCIPAL INVESTIGATOR
Badie Mansour, MD
OUHSC
Study Design
- Study Type
- interventional
- Phase
- phase 2
- Allocation
- RANDOMIZED
- Masking
- QUADRUPLE
- Who Masked
- PARTICIPANT, CARE PROVIDER, INVESTIGATOR, OUTCOMES ASSESSOR
- Purpose
- TREATMENT
- Intervention Model
- PARALLEL
- Sponsor Type
- OTHER
- Responsible Party
- SPONSOR
Study Record Dates
First Submitted
August 13, 2008
First Posted
August 14, 2008
Study Start
November 6, 2008
Primary Completion
September 1, 2009
Study Completion
September 1, 2009
Last Updated
April 28, 2017
Record last verified: 2017-04
Data Sharing
- IPD Sharing
- Will not share