Quantitative Sensory Testing and Analysis of Post Inguinal Hernia Surgery Pain

The recruitment status of this study is unknown because the information has not been verified recently.
Verified February 2012 by University of California, Los Angeles.
Recruitment status was  Recruiting
Sponsor:
Information provided by (Responsible Party):
Andrea Nicol, University of California, Los Angeles
ClinicalTrials.gov Identifier:
NCT01534429
First received: February 13, 2012
Last updated: NA
Last verified: February 2012
History: No changes posted
  Purpose

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.


Condition Intervention
Chronic Post-herniorraphy Pain
Procedure: Quantitative Sensory Testing

Study Type: Observational
Study Design: Observational Model: Cohort
Time Perspective: Prospective
Official Title: Quantitative Sensory Testing and Neurophysiologic Analysis of Post-Herniorraphy Pain in Patients Undergoing Selective Neurectomy and Mesh Removal

Further study details as provided by University of California, Los Angeles:

Primary Outcome Measures:
  • changes in quantitative sensory testing and neurophysiologic testing pre-operatively, and at 3-month and 6-month intervals post-operatively [ Time Frame: 6 months ] [ Designated as safety issue: No ]

Secondary Outcome Measures:
  • 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 ] [ Designated as safety issue: No ]

Estimated Enrollment: 25
Study Start Date: February 2011
Groups/Cohorts Assigned Interventions
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.

  Eligibility

Ages Eligible for Study:   18 Years and older
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No
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.

Criteria

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
  Contacts and Locations
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT01534429

Contacts
Contact: Andrea L Nicol, M.D. 310-794-1841 anicol@mednet.ucla.edu

Locations
United States, California
UCLA Medical Center Recruiting
Los Angeles, California, United States, 90095
Contact: Andrea L Nicol, M.D.    310-794-1841    anicol@mednet.ucla.edu   
Sponsors and Collaborators
University of California, Los Angeles
Investigators
Principal Investigator: Andrea L Nicol, M.D. University of California, Los Angeles
  More Information

No publications provided

Responsible Party: Andrea Nicol, Assistant Clinical Professor, University of California, Los Angeles
ClinicalTrials.gov Identifier: NCT01534429     History of Changes
Other Study ID Numbers: 11-000180
Study First Received: February 13, 2012
Last Updated: February 13, 2012
Health Authority: United States: Institutional Review Board

Keywords provided by University of California, Los Angeles:
pain

ClinicalTrials.gov processed this record on September 30, 2014