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CompletedNCT00719368Updated Apr 7, 2014

Neurophysiological Characterization of Postherniotomy Pain

An observational study in Postoperative Pain, Postherniotomy Pain and Neuropathic Pain, sponsored by Rigshospitalet, Denmark. Completed at 2 sites in Denmark. Open to participants aged 18 Years and older, including healthy volunteers. Per ClinicalTrials.gov, last updated 2014-04-07.

Sponsored by Rigshospitalet, Denmark · Observational

Study type
Observational
Model
Cohort
Enrollment
48
Ages
18 Years and older
Sex
All
01

Study 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.

02

Conditions studied

  • Postoperative Pain
  • Postherniotomy Pain
  • Neuropathic Pain

Keywords

  • Groin hernia
  • pain
  • chronic
  • quantitative sensory testing
  • Persistent postoperative pain
03

In context

Neuralgia

1,287 studies on the registry are indexed under Neuralgia; 256 are open to participants now.

This study's enrollment of 48 is below the median of 100 across 260 observational studies indexed under Neuralgia.

Browse Neuralgia studies →

Lead sponsor

Rigshospitalet, Denmark is the lead sponsor of 1,017 studies on the registry; 183 are open to participants now.

Counted across the registry records on this site, refreshed daily.

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Who can participate

Ages eligible
18 Years and older
Sexes eligible
All
Accepts healthy volunteers
Yes
Sampling method
Non-probability sample

Study population

persistent posthenriotomy patients

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

Exclusion Criteria:

  • Other causes of persistent pain in groin region (hip, other surgical procedures)
05

Study design

Observational model
Cohort
Enrollment
48 participants (actual)

Groups and 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

06

What researchers measure

Primary outcomes

  1. Sensory function

    Time frame: actual

07

Study locations

2 sites
  • Danish Pain Research Centre
    Aarhus, 8000, Denmark
  • Section for Surgical Pathophysiology
    Copenhagen, 2100, Denmark
08

References and documents

Publications

  • 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. PubMed 17976914 ↗
  • 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. PubMed 15531621 ↗
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Updates

Tracking since Sep 25, 2026
No changes since tracking began. The registry record was last updated on Apr 7, 2014, before this site started recording changes on Sep 25, 2026. Its history is on ClinicalTrials.gov ↗
10

Registry details

Key details

Study ID
NCT00719368
Lead sponsor
Rigshospitalet, Denmark
Responsible party
Eske Kvanner Aasvang (M.D., Rigshospitalet, Denmark) — Principal investigator
First posted
Jul 21, 2008
Start date
Jan 2006
Primary completion
Sep 2012
Completion
Sep 2012
Last update
Apr 7, 2014

Study contacts

Eske K Aasvang, M.D.
study director · Rigshospitalet, Copenhagen University, Denmark
Henrik Kehlet, M.D., Ph. D.
principal investigator · Rigshospitalet, Copenhagen University, Denmark

Oversight

Data monitoring committee
No
View the source record on ClinicalTrials.gov ↗

Not currently enrolling

This study is completed, as verified in Oct 2012. You cannot join it, but the record below documents what was studied.

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