Quantitative Sensory Testing and Analysis of Post Inguinal Hernia Surgery Pain

Completed

• Conditions: Hernia
• Interventions: Procedure: Quantitative Sensory Testing

• Registration Number: NCT01534429
• Lead Sponsor: University of California, Los Angeles

Brief 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.

Basic Information
|
Recruitment & Eligibility
|
Study & Design
|
Trial Locations

Study Timeline

• Study Start: 2011-02
• Study First Submitted: 2012-02-13
• Study First Submitted QC: 2012-02-13
• Study First Posted: 2012-02-16
• Primary Completion: 2016-01
• Study Completion: 2016-06
• Status Verified: 2016-07
• Last Update Submitted: 2016-07-07
• Last Update Posted: 2016-07-11

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 10

Inclusion Criteria

• patient with chronic groin pain after inguinal hernia surgery and are candidates for triple neurectomy with mesh removal

Read More

Exclusion Criteria

• non-English speaking patients
• significant psychiatric or medical disease
• bilateral groin pain

Read More

Study & Design

• Study Type: OBSERVATIONAL
• Study Design: Not specified

Arm && Interventions

Group	Intervention	Description
chronic post-herniorraphy pain	Quantitative Sensory Testing	patients with severe chronic post-herniorraphy pain

Primary Outcome Measures

Name	Time	Method
changes in quantitative sensory testing and neurophysiologic testing pre-operatively, and at 3-month and 6-month intervals post-operatively	6 months

Secondary Outcome Measures

Name	Time	Method
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	9 months

Trial Locations

Locations (1)

UCLA Medical Center; 🇺🇸 Los Angeles, California, United States