Neurophysiological Characterization of Postherniotomy Pain

NCT ID: NCT00719368

Last Updated: 2014-04-07

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

COMPLETED

Total Enrollment

48 participants

Study Classification

OBSERVATIONAL

Study Start Date

2006-01-31

Study Completion Date

2012-09-30

Brief Summary

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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.

Detailed Description

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Conditions

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Postoperative Pain Postherniotomy Pain Neuropathic Pain

Study Design

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Observational Model Type

COHORT

Study Groups

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pain-free control

Pain-free controls from previous prospective study (KF 01294867), operated \>2 years previously

No interventions assigned to this group

Pain Patients

Patients with persistent postherniotomy pain lasting \>1 year and pain related impaired daily function

No interventions assigned to this group

Eligibility Criteria

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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)
Minimum Eligible Age

18 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

Yes

Sponsors

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Rigshospitalet, Denmark

OTHER

Sponsor Role lead

Responsible Party

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Eske Kvanner Aasvang

M.D.

Responsibility Role PRINCIPAL_INVESTIGATOR

Principal Investigators

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Eske K Aasvang, M.D.

Role: STUDY_DIRECTOR

Rigshospitalet, Copenhagen University, Denmark

Henrik Kehlet, M.D., Ph. D.

Role: PRINCIPAL_INVESTIGATOR

Rigshospitalet, Copenhagen University, Denmark

Locations

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Danish Pain Research Centre

Aarhus, , Denmark

Site Status

Section for Surgical Pathophysiology

Copenhagen, , Denmark

Site Status

Countries

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Denmark

References

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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.

Reference Type BACKGROUND
PMID: 17976914 (View on PubMed)

Aasvang E, Kehlet H. Chronic postoperative pain: the case of inguinal herniorrhaphy. Br J Anaesth. 2005 Jul;95(1):69-76. doi: 10.1093/bja/aei019. Epub 2004 Nov 5. No abstract available.

Reference Type BACKGROUND
PMID: 15531621 (View on PubMed)

Other Identifiers

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KF 01267755

Identifier Type: -

Identifier Source: org_study_id

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