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

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ClinicalTrials.gov Identifier: NCT00735124
Recruitment Status : Terminated (Changes to surgical practices led to the loss of eligible patients)
First Posted : August 14, 2008
Last Update Posted : April 28, 2017
Information provided by (Responsible Party):

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.

Condition or disease Intervention/treatment Phase
Pain Analgesia Hernia, Inguinal Drug: Gabapentin Other: placebo Phase 2 Phase 3

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

Study Design

Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 5 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
Primary Purpose: Treatment
Official Title: An Investigation of Post-Operative Pain Scores and Analgesic Requirements After Ambulatory Inguinal Herniorrhaphy With Pre-Operative Gabapentin Therapy
Actual Study Start Date : November 6, 2008
Primary Completion Date : September 2009
Study Completion Date : September 2009

Resource links provided by the National Library of Medicine

U.S. FDA Resources

Arms and Interventions

Arm Intervention/treatment
Active Comparator: Single pre-op dose of Gabapentine
Active treatment with the study drug
Drug: Gabapentin
1200 mg single dose gabapentin
Other Name: Neurtonin
Placebo Comparator: Placebo
Placebo arm for blinding the medication
Other: placebo
Injection of placebo/sham

Outcome Measures

Primary Outcome Measures :
  1. Post operative pain is reduced when single pre-operative oral dose of Gabapentine is given to the patient before the Inguinal Herniorrhaphy [ Time Frame: 1yrs ]
    Post operative pain is reduced when single pre-operative oral dose of

Secondary Outcome Measures :
  1. The post operative analgesia requirement is also reduced [ Time Frame: 1yrs ]
    The post operative analgesia requirement is also reduced

Eligibility Criteria

Information from the National Library of Medicine

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Ages Eligible for Study:   18 Years to 70 Years   (Adult, Senior)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No

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
Contacts and Locations

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT00735124

United States, Oklahoma
Oklahoma City, Oklahoma, United States, 73152
Sponsors and Collaborators
University of Oklahoma
Principal Investigator: Badie Mansour, MD OUHSC
More Information

Responsible Party: University of Oklahoma
ClinicalTrials.gov Identifier: NCT00735124     History of Changes
Other Study ID Numbers: 14002
First Posted: August 14, 2008    Key Record Dates
Last Update Posted: April 28, 2017
Last Verified: April 2017
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: No

Keywords provided by University of Oklahoma:
analgesia requirement and post operative pain

Additional relevant MeSH terms:
Pain, Postoperative
Hernia, Inguinal
Neurologic Manifestations
Nervous System Diseases
Postoperative Complications
Pathologic Processes
Signs and Symptoms
Hernia, Abdominal
Pathological Conditions, Anatomical
Sensory System Agents
Peripheral Nervous System Agents
Physiological Effects of Drugs
Antiparkinson Agents
Anti-Dyskinesia Agents
Calcium Channel Blockers
Membrane Transport Modulators
Molecular Mechanisms of Pharmacological Action
Anti-Anxiety Agents
Tranquilizing Agents
Central Nervous System Depressants
Psychotropic Drugs
Excitatory Amino Acid Antagonists
Excitatory Amino Acid Agents
Neurotransmitter Agents
Antimanic Agents