Quantitative Sensory Testing and Analysis of Post Inguinal Hernia Surgery Pain

NCT01534429 | Completed

• 1 other identifier: 11-000180
• Study Type: observational
• Target: 10
• Locations: 1 country
• Sites: 1

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.

Conditions

Hernia

Keywords

pain

Outcome Measures

Primary Outcomes (1)

• changes in quantitative sensory testing and neurophysiologic testing pre-operatively, and at 3-month and 6-month intervals post-operatively

  6 months

Secondary Outcomes (1)

• 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

Study Arms (1)

chronic post-herniorraphy pain

patients with severe chronic post-herniorraphy pain

Procedure: Quantitative Sensory Testing

Interventions

Quantitative Sensory Testing PROCEDURE

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

chronic post-herniorraphy pain

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)
• 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.

You may qualify if:

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

You may not qualify if:

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

Sponsors & Collaborators

• University of California, Los Angeles: lead

Study Sites (1)

UCLA Medical Center

Los Angeles, California, 90095, United States

Location

MeSH Terms

Conditions

Hernia; Pain

Condition Hierarchy (Ancestors)

Pathological Conditions, Anatomical; Pathological Conditions, Signs and Symptoms; Neurologic Manifestations; Signs and Symptoms

Study Officials

• Andrea L Nicol, M.D.

  University of California, Los Angeles

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: observational
• Observational Model: COHORT
• Time Perspective: PROSPECTIVE
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: February 13, 2012
• First Posted: February 16, 2012
• Study Start: February 1, 2011
• Primary Completion: January 1, 2016
• Study Completion: June 1, 2016
• Last Updated: July 11, 2016

Record last verified: 2016-07

Data Sharing

• IPD Sharing: Will not share

Locations

US (1)