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

This study has been terminated.
(Changes to surgical practices led to the loss of eligible patients)
Sponsor:
ClinicalTrials.gov Identifier:
NCT00735124
First Posted: August 14, 2008
Last Update Posted: April 28, 2017
The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
Information provided by (Responsible Party):
University of Oklahoma
August 13, 2008
August 14, 2008
April 28, 2017
November 6, 2008
September 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 ]
Post operative pain is reduced when single pre-operative oral dose of
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 ]
Complete list of historical versions of study NCT00735124 on ClinicalTrials.gov Archive Site
The post operative analgesia requirement is also reduced [ Time Frame: 1yrs ]
The post operative analgesia requirement is also reduced
The post operative analgesia requirement is also reduced [ Time Frame: 1yrs ]
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
Intervention Model: Parallel Assignment
Masking: Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
Primary Purpose: Treatment
  • Pain
  • Analgesia
  • Hernia, Inguinal
  • Drug: Gabapentin
    1200 mg single dose gabapentin
    Other Name: Neurtonin
  • Other: placebo
    Injection of placebo/sham
  • 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: placebo
Not Provided

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Terminated
5
September 2009
September 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
Sexes Eligible for Study: All
18 Years to 70 Years   (Adult, Senior)
No
Contact information is only displayed when the study is recruiting subjects
United States
 
 
NCT00735124
14002
Yes
Not Provided
Plan to Share IPD: No
University of Oklahoma
University of Oklahoma
Not Provided
Principal Investigator: Badie Mansour, MD OUHSC
University of Oklahoma
April 2017

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