Try our beta test site

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

This study has suspended participant recruitment.
(Need amendments in application process and require IBD number from FDA)
Information provided by (Responsible Party):
University of Oklahoma Identifier:
First received: August 13, 2008
Last updated: June 13, 2012
Last verified: June 2012
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 Intervention Phase
Hernia, Inguinal
Drug: Gabapentin
Other: Sham or placebo
Phase 2
Phase 3

Study Type: Interventional
Study Design: Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Double Blind (Subject, Caregiver, 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

Resource links provided by NLM:

Further study details as provided by University of Oklahoma:

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 [ Time Frame: 1yrs ]

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

Estimated Enrollment: 240
Study Start Date: November 2008
Estimated Study Completion Date: December 2012
Primary Completion Date: December 2009 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
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: Sham or placebo
Injection of placebo/sham
Other Name: placebo

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

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
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its identifier: NCT00735124

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

Responsible Party: University of Oklahoma Identifier: NCT00735124     History of Changes
Other Study ID Numbers: 14002 
Study First Received: August 13, 2008
Last Updated: June 13, 2012

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 processed this record on March 01, 2017