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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.
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.
Age
18 - No limit years
Sex
ALL
Healthy Volunteers
Yes
Multidisciplinary Pain Center, Neuroscience Center, Copenhagen University Hospital, DENMARK
Copenhagen, Denmark
Start Date
November 1, 2013
Primary Completion Date
April 1, 2014
Completion Date
May 1, 2015
Last Updated
November 28, 2016
20
ACTUAL participants
Bupivacaine
DRUG
Placebo
DRUG
Lead Sponsor
University of Copenhagen
Collaborators
Data Source & Attribution
This clinical trial information is sourced from ClinicalTrials.gov, a service of the U.S. National Institutes of Health.
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View ClinicalTrials.gov Terms and ConditionsNCT06587607