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Completed

NCT Number: NCT01534429

Quantitative Sensory Testing and Analysis of Post Inguinal Hernia Surgery Pain

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.

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Key information

Conditions

Hernia Neurologic Manifestations Pain Pathological Conditions, Anatomical Pathological Conditions, Signs and Symptoms Signs and Symptoms

Age range

18 year and older

Sex eligibility

All sexes

Study type

Observational

Primary location

UCLA Medical Center

Los Angeles, California, 90095, United States

About this study

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.

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

Quantitative sensory testing

Procedure

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

Primary outcomes

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

    Time frame: 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

    Time frame: 9 months

Sponsors and collaborators

Lead sponsor

University of California, Los Angeles

Other

Registry information

Official study title

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

Important dates

Study start
2011
Primary completion
2016
Study completion
2016
First posted
Feb 16, 2012
Registry last updated
Jul 11, 2016

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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