Neurophysiological Characterization of Postherniotomy Pain

Postoperative Pain Clinical Trial

Official title:

Quantitative Sensory Testing in Persistent Postherniotomy Pain Patients

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT00719368
• Other study ID #: KF 01267755
• Status: Completed
• Phase: N/A
• First received: July 17, 2008
• Last updated: April 4, 2014
• Start date: January 2006
• Est. completion date: September 2012

Study information

• Verified date: October 2012
• Source: Rigshospitalet, Denmark
• Contact: n/a
• Is FDA regulated: No
• Health authority: Denmark: Ethics Committee
• Study type: Observational

Clinical Trial 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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 48
• Est. completion date: September 2012
• Est. primary completion date: September 2012
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: Both
• Age group: 18 Years and older

Eligibility

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)

Study Design

Observational Model: Cohort

Related Conditions & MeSH terms

• Neuralgia
• Neuropathic Pain
• Pain, Postoperative
• Postherniotomy Pain
• Postoperative Pain

Locations

Country	Name	City	State
Denmark	Danish Pain Research Centre	Aarhus
Denmark	Section for Surgical Pathophysiology	Copenhagen

Sponsors (1)

Lead Sponsor	Collaborator
Rigshospitalet, Denmark

Country where clinical trial is conducted

Denmark, 

References & Publications (2)

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. — View Citation

Aasvang EK, Brandsborg B, Christensen B, Jensen TS, Kehlet H. Neurophysiological characterization of postherniotomy pain. Pain. 2008 Jul;137(1):173-81. Epub 2007 Oct 31. Erratum in: Pain. 2012 Jan;153(1):253. — View Citation

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Sensory function		actual	No