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

August 13, 2008
June 13, 2012
November 2008
December 2009   (final data collection date for primary outcome measure)
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 ]
Same as current
Complete list of historical versions of study NCT00735124 on ClinicalTrials.gov Archive Site
The post operative analgesia requirement is also reduced [ Time Frame: 1yrs ] [ Designated as safety issue: Yes ]
Same as current
Not Provided
Not Provided
 
Post-Operative Pain Scores and Analgesic Requirements After Elective Inguinal Herniorrhaphy
An Investigation of Post-Operative Pain Scores and Analgesic Requirements After Ambulatory Inguinal Herniorrhaphy With Pre-Operative Gabapentin Therapy

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.

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

Interventional
Phase 2
Phase 3
Allocation: Randomized
Endpoint Classification: Safety/Efficacy Study
Intervention Model: Parallel Assignment
Masking: Double Blind (Subject, Caregiver, Investigator, Outcomes Assessor)
Primary Purpose: Treatment
  • Pain
  • Analgesia
  • Hernia, Inguinal
  • Drug: Gabapentin
    1200 mg single dose gabapentin
    Other Name: Neurtonin
  • Other: Sham or placebo
    Injection of placebo/sham
    Other Name: placebo
  • Active Comparator: Single pre-op dose of Gabapentine
    Active treatment with the study drug
    Intervention: Drug: Gabapentin
  • Placebo Comparator: Placebo
    Placebo arm for blinding the medication
    Intervention: Other: Sham or placebo
Not Provided

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Suspended
240
December 2012
December 2009   (final data collection date for primary outcome measure)

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
Both
18 Years to 70 Years
No
Contact information is only displayed when the study is recruiting subjects
United States
 
NCT00735124
14002
Yes
University of Oklahoma
University of Oklahoma
Not Provided
Principal Investigator: Badie Mansour, MD OUHSC
University of Oklahoma
June 2012

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP