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

University of Copenhagen

Status and phase

Completed

Phase 3

Conditions

Chronic Pain

Inguinal Hernia

Treatments

Drug: Bupivacaine

Drug: Placebo

Study type

Interventional

Funder types

Other

Identifiers

NCT02065219

2612-1006 (Other Identifier)

H-3-2011-130-open

Details and patient eligibility

About

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.

Full 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.

Enrollment

20 patients

Sex

All

Ages

18+ years old

Volunteers

Accepts Healthy Volunteers

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