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

• Status: Completed
• Trial end date: 2015-05-01
• Target enrollment: 0
• Participant gender: All

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.

• Phase: Phase 3
• Accepts Healthy Volunteers?: Accepts Healthy Volunteers

Details

• Lead Sponsor: University of Copenhagen
• Collaborator: Rigshospitalet, Denmark
• Treatments: Bupivacaine

Criteria

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 of Zealand (Region Sjælland)

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