Neurophysiological Characterization of Postherniotomy Pain

This study has been completed.
Sponsor:
Information provided by (Responsible Party):
Eske Kvanner Aasvang, Rigshospitalet, Denmark
ClinicalTrials.gov Identifier:
NCT00719368
First received: July 17, 2008
Last updated: April 4, 2014
Last verified: October 2012
  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 Rigshospitalet, Denmark:

Primary Outcome Measures:
  • Sensory function [ Time Frame: actual ] [ Designated as safety issue: No ]

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

Ages Eligible for Study:   18 Years and older
Genders Eligible for Study:   Both
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
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: 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
Study First Received: July 17, 2008
Last Updated: April 4, 2014
Health Authority: Denmark: Ethics Committee

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

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

ClinicalTrials.gov processed this record on September 18, 2014