The Impact of Perioperative Gabapentin on Chronic Groin Pain After Inguinal Hernia Repair
|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.|
|ClinicalTrials.gov Identifier: NCT02419443|
Recruitment Status : Unknown
Verified April 2016 by Matthew Hannon, United States Naval Medical Center, San Diego.
Recruitment status was: Active, not recruiting
First Posted : April 17, 2015
Last Update Posted : April 11, 2016
|Condition or disease||Intervention/treatment||Phase|
|Peripheral Nerve Disorder Associated With Repair of Hernia||Drug: Gabapentin Drug: Placebo||Phase 4|
|Study Type :||Interventional (Clinical Trial)|
|Estimated Enrollment :||100 participants|
|Intervention Model:||Parallel Assignment|
|Masking:||Triple (Participant, Care Provider, Investigator)|
|Official Title:||The Impact of Perioperative Gabapentin on Chronic Groin Pain After Inguinal Hernia Repair|
|Study Start Date :||August 2011|
|Actual Primary Completion Date :||September 2015|
|Estimated Study Completion Date :||September 2016|
Placebo Comparator: Placebo
Patients randomized to the placebo-group were administered placebo-pills orally one hour prior to surgery, then three times a day for a maximum of 6 total doses.
Active Comparator: Gabapentin
Patients randomized to the gabapentin-group were administered 300 mg orally one hour prior to surgery, then three times a day for a maximum of 6 total dose.
Gabapentin is a structural analogue of GABA that decreases activation of voltage-activated calcium channels which may decrease release of excitatory neurotransmitters such as glutamate. Its analgesic mechanisms have been utilized effectively for the treatment of chronic pain in several disorders such as cancer, fibromyalgia and diabetic peripheral neuropathy.
Other Name: Neurontin
- Pain score [ Time Frame: 24 months ]Visual analog scale
- Quality-of-life (QOL) [ Time Frame: 24 months ]SF-12
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): NCT02419443
|Principal Investigator:||Matthew Hannon, M.D.||United States Naval Medical Center, San Diego|