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Post-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
University of Oklahoma
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Pain focused on measuring analgesia requirement and post operative pain

Eligibility Criteria

18 Years - 70 Years (Adult, Older Adult)All SexesDoes not accept healthy volunteers

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

First Posted
August 13, 2008
Last Updated
April 26, 2017
Sponsor
University of Oklahoma
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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

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Post-Operative Pain Scores and Analgesic Requirements After Elective Inguinal Herniorrhaphy

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