Clinical Trials Directory

Trials / Completed

CompletedNCT01534429

Quantitative Sensory Testing and Analysis of Post Inguinal Hernia Surgery Pain

Quantitative Sensory Testing and Neurophysiologic Analysis of Post-Herniorraphy Pain in Patients Undergoing Selective Neurectomy and Mesh Removal

Status
Completed
Phase
Study type
Observational
Enrollment
10 (actual)
Sponsor
University of California, Los Angeles · Academic / Other
Sex
All
Age
18 Years
Healthy volunteers
Not accepted

Summary

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.

Detailed description

Background: Chronic postherniorrhaphy inguinal pain is a complex, major health problem. In the absence of recurrence or meshoma, laparoscopic retroperitoneal triple neurectomy has emerged as an effective surgical treatment of postherniorrhaphy inguinal pain. Methods: This prospective pilot study evaluated the neurophysiological and clinical effects of laparoscopic retroperitoneal triple neurectomy. Ten consecutive adult with chronic postherniorrhaphy inguinal pain and unilateral predominantly neuropathic inguinodynia underwent three comprehensive quantitative sensory testing assessments (preoperative, immediate postoperative, and late postoperative). Pain severity, health-related function, and sleep quality were assessed over the course of a 6-month follow-up period.

Conditions

Interventions

TypeNameDescription
PROCEDUREQuantitative Sensory TestingQuantitative Sensory Testing and Neurophysiologic Testing to be done Pre-operatively and at 3 and 6 months post-operatively.

Timeline

Start date
2011-02-01
Primary completion
2016-01-01
Completion
2016-06-01
First posted
2012-02-16
Last updated
2016-07-11

Locations

1 site across 1 country: United States

Source: ClinicalTrials.gov record NCT01534429. Inclusion in this directory is not an endorsement.