Overview

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

Status:
Completed
Trial end date:
2014-07-01
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 laparoscopical groin hernia repair.
Phase:
Phase 3
Accepts Healthy Volunteers?
No
Details
Lead Sponsor:
University of Copenhagen
Treatments:
Bupivacaine
Criteria
Inclusion Criteria:

- Patients with persistent pain (< 6 mo) after laparoscopical 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 writing or speech

- 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