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Neurophysiological Characterization of Postherniotomy Pain

This study has been completed.
Sponsor:
ClinicalTrials.gov Identifier:
NCT00719368
First Posted: July 21, 2008
Last Update Posted: April 7, 2014
The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
Information provided by (Responsible Party):
Eske Kvanner Aasvang, Rigshospitalet, Denmark
  Purpose
Sensory function is different in persistent postherniotomy pain patients than in operated controls, suggesting this to be a neuropathic pain syndrome. By performing quantitative sensory testing, the specific changes in pain patients will be revealed, thereby aiding in designing future treatment trials. MRI scans of the groin regions in pain patients and control patients will be evaluated by senior MRI specialists assessing potential pathology to the region (Mesh, inflammation, edema, funicle etc.) Assessors will be blinded to clinical status, and surgery.

Condition
Postoperative Pain Postherniotomy Pain Neuropathic Pain

Study Type: Observational
Study Design: Observational Model: Cohort
Official Title: Quantitative Sensory Testing in Persistent Postherniotomy Pain Patients

Further study details as provided by Eske Kvanner Aasvang, Rigshospitalet, Denmark:

Primary Outcome Measures:
  • Sensory function [ Time Frame: actual ]

Enrollment: 48
Study Start Date: January 2006
Study Completion Date: September 2012
Primary Completion Date: September 2012 (Final data collection date for primary outcome measure)
Groups/Cohorts
pain-free control
Pain-free controls from previous prospective study (KF 01294867), operated >2 years previously
Pain Patients
Patients with persistent postherniotomy pain lasting >1 year and pain related impaired daily function

  Eligibility

Information from the National Library of Medicine

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Ages Eligible for Study:   18 Years and older   (Adult, Senior)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   Yes
Sampling Method:   Non-Probability Sample
Study Population
persistent posthenriotomy patients
Criteria

Inclusion Criteria:

  • Male patients >18 yrs
  • Inguinal herniotomy >1 yr previously
  • No sign of hernia recurrence
  • Unilateral chronic groin pain lasting more than 3 months
  • Moderate/severe pain related impairment of everyday activities.

Exclusion Criteria:

  • Other causes of persistent pain in groin region (hip, other surgical procedures)
  Contacts and Locations
Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT00719368


Locations
Denmark
Danish Pain Research Centre
Aarhus, Denmark, 8000
Section for Surgical Pathophysiology
Copenhagen, Denmark, 2100
Sponsors and Collaborators
Rigshospitalet, Denmark
Investigators
Study Director: Eske K Aasvang, M.D. Rigshospitalet, Copenhagen University, Denmark
Principal Investigator: Henrik Kehlet, M.D., Ph. D. Rigshospitalet, Copenhagen University, Denmark
  More Information

Publications:
Responsible Party: Eske Kvanner Aasvang, M.D., Rigshospitalet, Denmark
ClinicalTrials.gov Identifier: NCT00719368     History of Changes
Other Study ID Numbers: KF 01267755
First Submitted: July 17, 2008
First Posted: July 21, 2008
Last Update Posted: April 7, 2014
Last Verified: October 2012

Keywords provided by Eske Kvanner Aasvang, Rigshospitalet, Denmark:
Groin hernia
pain
chronic
quantitative sensory testing
Persistent postoperative pain

Additional relevant MeSH terms:
Pain, Postoperative
Neuralgia
Pain
Neurologic Manifestations
Nervous System Diseases
Postoperative Complications
Pathologic Processes
Signs and Symptoms
Peripheral Nervous System Diseases
Neuromuscular Diseases