Back to resultsPost-Operative Pain Scores and Analgesic Requirements After Elective Inguinal Herniorrhaphy
Primary Purpose
Pain, Analgesia, Hernia, Inguinal
Status
Terminated
Phase
Phase 2
Locations
United States
Study Type
Interventional
Intervention
Gabapentin
placebo
Sponsored by
About this trial
This is an interventional treatment trial for Pain focused on measuring analgesia requirement and post operative pain
Eligibility Criteria
Inclusion Criteria:
- Subjects having elective surgery with open unilateral Inguinal herniorraphy
Exclusion Criteria:
- 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
Sites / Locations
- OUHSC
Arms of the Study
Arm 1
Arm 2
Arm Type
Active Comparator
Placebo Comparator
Arm Label
Single pre-op dose of Gabapentine
Placebo
Arm Description
Active treatment with the study drug
Placebo arm for blinding the medication
Outcomes
Primary Outcome Measures
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
Secondary Outcome Measures
The post operative analgesia requirement is also reduced
The post operative analgesia requirement is also reduced
Full Information
1. Study Identification
Unique Protocol Identification Number
NCT00735124
Brief Title
Post-Operative Pain Scores and Analgesic Requirements After Elective Inguinal Herniorrhaphy
Official Title
An Investigation of Post-Operative Pain Scores and Analgesic Requirements After Ambulatory Inguinal Herniorrhaphy With Pre-Operative Gabapentin Therapy
Study Type
Interventional
2. Study Status
Record Verification Date
April 2017
Overall Recruitment Status
Terminated
Why Stopped
Changes to surgical practices led to the loss of eligible patients
Study Start Date
November 6, 2008 (Actual)
Primary Completion Date
September 2009 (Actual)
Study Completion Date
September 2009 (Actual)
3. Sponsor/Collaborators
Responsible Party, by Official Title
Sponsor
Name of the Sponsor
University of Oklahoma
4. Oversight
Data Monitoring Committee
Yes
5. Study Description
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.
Detailed Description
The study will benefit patients in reducing post-operative pain scores as well as reduction in oral analgesic consumption. Gabapentin has been shown to reduce post operative pain pain scores in breast surgery, hysterectomy , spinal surgery, orthopedic and thyroid surgery
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Pain, Analgesia, Hernia, Inguinal
Keywords
analgesia requirement and post operative pain
7. Study Design
Primary Purpose
Treatment
Study Phase
Phase 2, Phase 3
Interventional Study Model
Parallel Assignment
Masking
ParticipantCare ProviderInvestigatorOutcomes Assessor
Allocation
Randomized
Enrollment
5 (Actual)
8. Arms, Groups, and Interventions
Arm Title
Single pre-op dose of Gabapentine
Arm Type
Active Comparator
Arm Description
Active treatment with the study drug
Arm Title
Placebo
Arm Type
Placebo Comparator
Arm Description
Placebo arm for blinding the medication
Intervention Type
Drug
Intervention Name(s)
Gabapentin
Other Intervention Name(s)
Neurtonin
Intervention Description
1200 mg single dose gabapentin
Intervention Type
Other
Intervention Name(s)
placebo
Intervention Description
Injection of placebo/sham
Primary Outcome Measure Information:
Title
Post operative pain is reduced when single pre-operative oral dose of Gabapentine is given to the patient before the Inguinal Herniorrhaphy
Description
Post operative pain is reduced when single pre-operative oral dose of
Time Frame
1yrs
Secondary Outcome Measure Information:
Title
The post operative analgesia requirement is also reduced
Description
The post operative analgesia requirement is also reduced
Time Frame
1yrs
10. Eligibility
Sex
All
Minimum Age & Unit of Time
18 Years
Maximum Age & Unit of Time
70 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
Inclusion Criteria:
Subjects having elective surgery with open unilateral Inguinal herniorraphy
Exclusion Criteria:
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
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Badie Mansour, MD
Organizational Affiliation
OUHSC
Official's Role
Principal Investigator
Facility Information:
Facility Name
OUHSC
City
Oklahoma City
State/Province
Oklahoma
ZIP/Postal Code
73152
Country
United States
12. IPD Sharing Statement
Plan to Share IPD
No
Learn more about this trial
Post-Operative Pain Scores and Analgesic Requirements After Elective Inguinal Herniorrhaphy
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