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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)
Sponsor:
Information provided by (Responsible Party):
University of Oklahoma
ClinicalTrials.gov Identifier:
NCT00735124
First received: August 13, 2008
Last updated: June 13, 2012
Last verified: June 2012
History of Changes
  Purpose

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
Pain
Analgesia
Hernia, Inguinal
 Drug: Gabapentin
Other: Sham or placebo
 Phase 2
Phase 3

Study Type: Interventional
Study Design: Allocation: Randomized
Endpoint Classification: Safety/Efficacy Study
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:

MedlinePlus related topics: Hernia
U.S. FDA Resources

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 ] [ Designated as safety issue: Yes ]

Secondary Outcome Measures:
  • The post operative analgesia requirement is also reduced [ Time Frame: 1yrs ] [ Designated as safety issue: Yes ]

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

  Eligibility

Ages Eligible for Study:   18 Years to 70 Years
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No
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
  Contacts and Locations
Please refer to this study by its ClinicalTrials.gov identifier: NCT00735124

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

No publications provided

Responsible Party: University of Oklahoma
ClinicalTrials.gov Identifier: NCT00735124     History of Changes
Other Study ID Numbers: 14002
Study First Received: August 13, 2008
Last Updated: June 13, 2012
Health Authority: United States: Food and Drug Administration

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

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

ClinicalTrials.gov processed this record on May 16, 2013