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

NCT ID: NCT00735124

Last Updated: 2017-04-28

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

TERMINATED

Clinical Phase

PHASE2/PHASE3

Total Enrollment

5 participants

Study Classification

INTERVENTIONAL

Study Start Date

2008-11-06

Study Completion Date

2009-09-30

Brief Summary

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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

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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

Conditions

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Pain Analgesia Hernia, Inguinal

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

Primary Study Purpose

TREATMENT

Blinding Strategy

QUADRUPLE

Participants Caregivers Investigators Outcome Assessors

Study Groups

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Single pre-op dose of Gabapentine

Active treatment with the study drug

Group Type ACTIVE_COMPARATOR

Gabapentin

Intervention Type DRUG

1200 mg single dose gabapentin

Placebo

Placebo arm for blinding the medication

Group Type PLACEBO_COMPARATOR

placebo

Intervention Type OTHER

Injection of placebo/sham

Interventions

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Gabapentin

1200 mg single dose gabapentin

Intervention Type DRUG

placebo

Injection of placebo/sham

Intervention Type OTHER

Other Intervention Names

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Neurtonin

Eligibility Criteria

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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
Minimum Eligible Age

18 Years

Maximum Eligible Age

70 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No

Sponsors

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University of Oklahoma

OTHER

Sponsor Role lead

Responsible Party

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Responsibility Role SPONSOR

Principal Investigators

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Badie Mansour, MD

Role: PRINCIPAL_INVESTIGATOR

OUHSC

Locations

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OUHSC

Oklahoma City, Oklahoma, United States

Site Status

Countries

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United States

Other Identifiers

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14002

Identifier Type: -

Identifier Source: org_study_id

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