NCT02065219

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

• Status: Completed
• Phase: Phase 3
• Study type: Interventional
• Enrollment: 20 (actual)
• Sponsor: University of Copenhagen · Academic / Other
• Sex: All
• Age: 18 Years
• Healthy volunteers: Accepted

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.

Detailed 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.

Conditions

• Inguinal Hernia
• Chronic Pain

Interventions

Type	Name	Description
DRUG	Bupivacaine	10 ml of bupivacaine 2.5 mg/ml deposited by ultra-sound guidance around the spermatic cord
DRUG	Placebo	10 ml 0.9% physiological saline deposited by ultra-sound guidance around the spermatic cord

Timeline

• Start date: 2013-11-01
• Primary completion: 2014-04-01
• Completion: 2015-05-01
• First posted: 2014-02-17
• Last updated: 2016-11-28

Locations

1 site across 1 country: Denmark