Neurophysiological Characterization of Postherniotomy Pain

NCT00719368 | Completed

• 1 other identifier: KF 01267755
• Study Type: observational
• Target: 48
• Locations: 1 country
• Sites: 2

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.

Conditions

Postoperative Pain; Postherniotomy Pain; Neuropathic Pain

Keywords

Groin hernia; pain; chronic; quantitative sensory testing; Persistent postoperative pain

Outcome Measures

Primary Outcomes (1)

• Sensory function

  actual

Study Arms (2)

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 Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64), Older Adult (65+)
• Sampling Method: Non-Probability Sample

Study Population

persistent posthenriotomy patients

You may qualify if:

• 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.

You may not qualify if:

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

Sponsors & Collaborators

• Rigshospitalet, Denmark: lead

Study Sites (2)

Danish Pain Research Centre

Aarhus, 8000, Denmark

Location

Section for Surgical Pathophysiology

Copenhagen, 2100, Denmark

Location

Related Publications (2)

• 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.

  PMID: 17976914 BACKGROUND

• 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.

  PMID: 15531621 BACKGROUND

MeSH Terms

Conditions

Pain, Postoperative; Neuralgia; Hernia, Inguinal; Pain; Bronchiolitis Obliterans Syndrome

Condition Hierarchy (Ancestors)

Postoperative Complications; Pathologic Processes; Pathological Conditions, Signs and Symptoms; Neurologic Manifestations; Signs and Symptoms; Peripheral Nervous System Diseases; Neuromuscular Diseases; Nervous System Diseases; Hernia, Abdominal; Hernia; Pathological Conditions, Anatomical; Organizing Pneumonia; Bronchiolitis Obliterans; Bronchiolitis; Bronchitis; Bronchial Diseases; Respiratory Tract Diseases; Lung Diseases, Obstructive; Lung Diseases; Graft vs Host Disease; Immune System Diseases

Study Officials

• Eske K Aasvang, M.D.

  Rigshospitalet, Copenhagen University, Denmark

  STUDY DIRECTOR

• Henrik Kehlet, M.D., Ph. D.

  Rigshospitalet, Copenhagen University, Denmark

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: observational
• Observational Model: COHORT
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: M.D.

Study Record Dates

• First Submitted: July 17, 2008
• First Posted: July 21, 2008
• Study Start: January 1, 2006
• Primary Completion: September 1, 2012
• Study Completion: September 1, 2012
• Last Updated: April 7, 2014

Record last verified: 2012-10

Locations

DK (2)