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

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.

Study Overview

• Status: Completed
• Conditions: Hernia
• Intervention / Treatment: Procedure: Quantitative Sensory Testing

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.

• Study Type: Observational
• Enrollment (Actual): 10

Contacts and Locations

Study Locations

• United States
  • California
    • Los Angeles, California, United States, 90095
      • UCLA Medical Center

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 18 years and older (ADULT, OLDER_ADULT)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: All

• Sampling Method: Non-Probability Sample

Study Population

Patients with chronic pain occuring after groin hernia repair who are surgical candidates for mesh removal and triple neurectomy.

Description

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

Study Plan

How is the study designed?

Number of groups / cohorts

1

Cohorts and Interventions

Group / Cohort	Intervention / Treatment
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.

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Time Frame
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

Outcome Measure	Time Frame
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

Collaborators and Investigators

• Sponsor: University of California, Los Angeles
• Investigators: Principal Investigator: Andrea L Nicol, M.D., University of California, Los Angeles

Study record dates

Study Major Dates

• Study Start: February 1, 2011
• Primary Completion (ACTUAL): January 1, 2016
• Study Completion (ACTUAL): June 1, 2016

Study Registration Dates

• First Submitted: February 13, 2012
• First Submitted That Met QC Criteria: February 13, 2012
• First Posted (ESTIMATE): February 16, 2012

Study Record Updates

• Last Update Posted (ESTIMATE): July 11, 2016
• Last Update Submitted That Met QC Criteria: July 7, 2016
• Last Verified: July 1, 2016

More Information

Terms related to this study

• Keywords: pain
• Additional Relevant MeSH Terms: Pathological Conditions, Anatomical; Hernia
• Other Study ID Numbers: 11-000180

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: NO