Neurophysiological Characterization of Postherniotomy Pain

• Sponsor: Rigshospitalet, Denmark (Other)
• Overall Status: Completed
• CT.gov ID: NCT00719368
• Collaborator: (none)
• Enrollment: 48
• Locations: 2
• Duration (Months): 80
• Patients Per Site: 24
• Patients Per Site Per Month: 0.3

Study Details

Study Description

Brief Summary

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 or Disease	Intervention/Treatment	Phase
Postoperative Pain; Postherniotomy Pain; Neuropathic Pain

Study Design

• Study Type: Observational
• Actual Enrollment: 48 participants
• Observational Model: Cohort
• Official Title: Quantitative Sensory Testing in Persistent Postherniotomy Pain Patients
• Study Start Date: Jan 1, 2006
• Actual Primary Completion Date: Sep 1, 2012
• Actual Study Completion Date: Sep 1, 2012

Arms and Interventions

Arm	Intervention/Treatment
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

Outcome Measures

Primary Outcome Measures

1. Sensory function [actual]

Eligibility Criteria

Criteria

• Ages Eligible for Study: 18 Years and Older
• Sexes Eligible for Study: All
• Accepts Healthy Volunteers: Yes

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

Locations

	Site	City	State	Country	Postal Code
1	Danish Pain Research Centre	Aarhus		Denmark	8000
2	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

Study Documents (Full-Text)

None provided.

More Information

Publications

• Aasvang E, Kehlet H. Chronic postoperative pain: the case of inguinal herniorrhaphy. Br J Anaesth. 2005 Jul;95(1):69-76. Epub 2004 Nov 5. Review.
• Aasvang EK, Brandsborg B, Christensen B, Jensen TS, Kehlet H. Neurophysiological characterization of postherniotomy pain. Pain. 2008 Jul;137(1):173-181. doi: 10.1016/j.pain.2007.09.026. Epub 2007 Oct 31. Erratum in: Pain. 2012 Jan;153(1):253.

• Responsible Party: Eske Kvanner Aasvang, M.D., Rigshospitalet, Denmark
• ClinicalTrials.gov Identifier: NCT00719368
• Other Study ID Numbers: KF 01267755
• First Posted: Jul 21, 2008
• Last Update Posted: Apr 7, 2014
• Last Verified: Oct 1, 2012

• Keywords provided by Eske Kvanner Aasvang, M.D., Rigshospitalet, Denmark: Groin hernia; pain; chronic; quantitative sensory testing; Persistent postoperative pain
• Additional relevant MeSH terms: Neuralgia; Pain, Postoperative

Study Results

No Results Posted as of Apr 7, 2014