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

University of Copenhagen

Status and phase: Completed; Phase 3

Conditions: Chronic Pain

Treatments: Drug: Bupivacaine

Study type: Interventional

Funder types: Other

Identifiers

NCT02065804

H-3-2011-130-lap

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 laparoscopical groin hernia repair.

Full description

This placebo-controlled, randomized, double-blind, cross-over study in subjects with severe pain after laparoscopically assisted groin hernia repair, 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.

Enrollment: 14 patients

Sex: All

Ages: 18+ years old

Volunteers: No Healthy Volunteers

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

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Crossover Assignment

Masking: Quadruple Blind

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14 participants in 2 patient groups, including a placebo group

Active drug

Experimental group

Description:

10 ml of bupivacaine 2.5 mg/ml deposited by ultra-sound guidance around the spermatic cord

Treatment:

Drug: Bupivacaine

Placebo

Placebo Comparator group

Description:

10 ml of normal saline deposited by ultra-sound guidance around the spermatic cord

Treatment:

Drug: Bupivacaine