Trigger-point Blockade in Persistent Pain After Open Groin Hernia Repair

Last updated: November 23, 2016
Sponsor: University of Copenhagen
Overall Status: Completed

Phase

3

Condition

Chronic Pain

Pain

Hernia

Treatment

N/A

Clinical Study ID

NCT02065219
H-3-2011-130-open
2612-1006
  • Ages > 18
  • All Genders
  • Accepts Healthy Volunteers

Study Summary

Groin hernia repair is a common procedure performed in approximately 2,000 patients per one million inhabitants. Severe chronic pain following groin hernia repair is seen in 2-5% of the patients indicating that a large number of patients each year suffer from debilitating reduction in health-related quality of life.

This study examines the effect of ultra-sound guided blocks with local anesthesia in the groin in regard to pain relief and sleep quality.

The hypothesis of the study is that a block will confer significant pain relief to patients with severe chronic pain following open groin hernia repair.

Eligibility Criteria

Inclusion

Inclusion Criteria:

  • Patients with persistent pain (< 6 mo) after open groin hernia repair

  • Patients with maximal pain area 3 cm or less from the superficial inguinal ring

  • Patients living in the Capital Region of Denmark (Region Hovedstaden) or the Region ofZealand (Region Sjælland)

Exclusion

Exclusion Criteria:

  • Known allergy to bupivacaine or other local anesthetics of amide-type

  • Declared incapable of making his/hers own affairs

  • Does not comprehend Danish in the written or spoken language

  • Cognitive impairment to a degree influencing the testing reliability

  • Known recurrence of the inguinal hernia

  • Other surgical procedures performed in the groin or on the external genitals

  • Neuropathy affecting the groin region caused by other conditions, e.g. post-stroke,multiple sclerosis, herniated intervertebral disc

  • Abuse of alcohol or drugs

  • Unable to cooperate with the sensory examinations

Study Design

Total Participants: 20
Study Start date:
November 01, 2013
Estimated Completion Date:
May 31, 2015

Study Description

This placebo-controlled, randomized, double-blind, cross-over study in subjects with severe pain after open groin hernia, examines the effect of an ultra-sound guided local anesthetic block of a trigger-point, situated near the spermatic cord at the superficial inguinal ring. In order to compare effects and distribution of the blocks in patients vs. healthy subjects, the block is tested and examined in volunteers using a similar methodology.

Connect with a study center

  • Multidisciplinary Pain Center, Neuroscience Center, Copenhagen University Hospital, DENMARK

    Copenhagen, 2100
    Denmark

    Site Not Available

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