Quantitative Sensory Testing and Analysis of Post Inguinal Hernia Surgery Pain
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Purpose
Increasing experience has identified post-herniorraphy chronic pain as an under-recognized and important complication. Nerve entrapment and injury are recognized as causes of such pain. Operative treatment for selected patients with this condition includes surgical exploration of the affected groin, identification and removal of involved nerves, and removal of meshoma. This procedure has been highly effective in treatment of chronic pain. This study will attempt to subjectively and objectively evaluate the patient's chronic groin pain using quantitative sensory testing (QST) and validated pain scales and questionnaires. Quantitative sensory testing is a method used to assess damage to the small and large nerve fibers. It is used to diagnose and assess the severity of nerve damage, and can also help to determine if a neuropathy is responding to treatment. QST uses a computer testing system to measure how nerves react to vibration and changes in temperature. The procedure is non-invasive and the patient will feel minimal to no discomfort during testing. The hypothesis is that any decrease in subjective pain scores would be accompanied by improved QST results.
| Condition | Intervention |
|---|---|
|
Chronic Post-herniorraphy Pain |
Procedure: Quantitative Sensory Testing |
| Study Type: | Observational |
| Study Design: | Observational Model: Cohort Time Perspective: Prospective |
| Official Title: | Quantitative Sensory Testing and Neurophysiologic Analysis of Post-Herniorraphy Pain in Patients Undergoing Selective Neurectomy and Mesh Removal |
- changes in quantitative sensory testing and neurophysiologic testing pre-operatively, and at 3-month and 6-month intervals post-operatively [ Time Frame: 6 months ] [ Designated as safety issue: No ]
- changes in Visual Nociceptive Pain Scores, McGill Pain Questionnaire, Activity Assessment Scale, and SF-36 scale pre-operatively and 3-month, 6-month, and 9-months post-operatively [ Time Frame: 9 months ] [ Designated as safety issue: No ]
| Estimated Enrollment: | 25 |
| Study Start Date: | February 2011 |
| Groups/Cohorts | Assigned Interventions |
|---|---|
|
chronic post-herniorraphy pain
patients with severe chronic post-herniorraphy pain
|
Procedure: Quantitative Sensory Testing
Quantitative Sensory Testing and Neurophysiologic Testing to be done Pre-operatively and at 3 and 6 months post-operatively.
|
Eligibility| Ages Eligible for Study: | 18 Years and older |
| Genders Eligible for Study: | Both |
| Accepts Healthy Volunteers: | No |
| Sampling Method: | Non-Probability Sample |
Patients with chronic pain occuring after groin hernia repair who are surgical candidates for mesh removal and triple neurectomy.
Inclusion Criteria:
- patient with chronic groin pain after inguinal hernia surgery and are candidates for triple neurectomy with mesh removal
Exclusion Criteria:
- non-English speaking patients
- significant psychiatric or medical disease
- bilateral groin pain
Contacts and Locations| Contact: Andrea L Nicol, M.D. | 310-794-1841 | anicol@mednet.ucla.edu |
| United States, California | |
| UCLA Medical Center | Recruiting |
| Los Angeles, California, United States, 90095 | |
| Contact: Andrea L Nicol, M.D. 310-794-1841 anicol@mednet.ucla.edu | |
| Principal Investigator: | Andrea L Nicol, M.D. | University of California, Los Angeles |
More Information
No publications provided
| Responsible Party: | Andrea Nicol, Assistant Clinical Professor, University of California, Los Angeles |
| ClinicalTrials.gov Identifier: | NCT01534429 History of Changes |
| Other Study ID Numbers: | 11-000180 |
| Study First Received: | February 13, 2012 |
| Last Updated: | February 13, 2012 |
| Health Authority: | United States: Institutional Review Board |
Keywords provided by University of California, Los Angeles:
|
pain |
ClinicalTrials.gov processed this record on May 23, 2013