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

Phase 3CompletedNCT02065804

University of Copenhagen14 enrolled

Overview

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.

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.

Study Type

INTERVENTIONAL

Allocation

RANDOMIZED

Purpose

TREATMENT

Masking

QUADRUPLE

Enrollment

Conditions

Chronic Pain

Interventions

Eligibility

Sex: ALLMin age: 18 Years

Medical Language ↔ Plain English

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

Outcomes

Primary Outcomes

Normalized summed pain intensity differences (SPID)

The number of patients with normalized summed pain intensity differences (SPID) of more or equal to 50% after bupivacaine AND SPID less or equal to 25% after placebo.

Time frame: 20 min

Secondary Outcomes

Thermal thresholds

Quantitative changes in thermal thresholds (warmth detection threshold, cool detection thresholds, heat pain threshold) after bupivacaine compared to placebo

Time frame: 20 min

Suprathreshold heat stimulation

Quantitative changes in pain rating to suprathreshold heat stimulation after bupivacaine compared to placebo

Time frame: 20 min

Pressure pain thresholds

Quantitative changes in pain rating to pressure algometry stimulation after bupivacaine compared to placebo

Time frame: 20 min

Sensory mapping

Quantitative changes in area of cool hypoesthesia assessed by a thermal roller after bupivacaine compared to placebo

Time frame: 20 min

Pain questionnaire

Quantitative changes in summed pain intensity differences (SPIDs) assessed morning and evening after bupivacaine compared to placebo

Time frame: 7 days

Sleep quality questionnaire

Quantitative changes in sleep quality assessed each morning after bupivacaine compared to placebo

Time frame: 7 days

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

Overview

Conditions

Interventions

Eligibility

Locations (1)

Outcomes

Primary Outcomes

Secondary Outcomes