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

NCT ID: NCT02065804

Last Updated: 2017-10-18

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

COMPLETED

Clinical Phase

PHASE3

Total Enrollment

14 participants

Study Classification

INTERVENTIONAL

Study Start Date

2013-10-31

Study Completion Date

2014-07-31

Brief Summary

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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.

Detailed Description

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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.

Conditions

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Chronic Pain

Keywords

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Herniorrhaphy Surgical Equipment Chronic Pain Inguinal Herniorrhaphy Laparoscopy Surgical Outcome

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

CROSSOVER

Primary Study Purpose

TREATMENT

Blinding Strategy

QUADRUPLE

Participants Caregivers Investigators Outcome Assessors

Study Groups

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Active drug

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

Group Type EXPERIMENTAL

Bupivacaine

Intervention Type DRUG

injection, once, 5 min

Placebo

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

Group Type PLACEBO_COMPARATOR

Bupivacaine

Intervention Type DRUG

injection, once, 5 min

Interventions

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Bupivacaine

injection, once, 5 min

Intervention Type DRUG

Other Intervention Names

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Bupivacain "SAD" 0.9% Sodium-chloride

Eligibility Criteria

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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
Minimum Eligible Age

18 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No

Sponsors

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University of Copenhagen

OTHER

Sponsor Role lead

Responsible Party

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mads u werner

MD, DMSc

Responsibility Role PRINCIPAL_INVESTIGATOR

Principal Investigators

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Mads Werner

Role: PRINCIPAL_INVESTIGATOR

Multidisciplinary Pain Center, Neuroscience Center, Rigshospitalet, Copenhagen University Hospital, DENMARK

Henrik Kehlet, MD, DMSc

Role: STUDY_CHAIR

Section of Surgical Pathophysiology, Juliane Marie Center, Copenhagen University Hospital, DENMARK

Locations

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Multidisciplinary Pain Center, Neuroscience Center, Copenhagen University Hospital, DENMARK

Copenhagen, , Denmark

Site Status

Countries

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Denmark

References

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Linderoth G, Kehlet H, Aasvang EK, Werner MU. Neurophysiological characterization of persistent pain after laparoscopic inguinal hernia repair. Hernia. 2011 Oct;15(5):521-9. doi: 10.1007/s10029-011-0815-z. Epub 2011 Apr 9.

Reference Type BACKGROUND
PMID: 21479588 (View on PubMed)

Other Identifiers

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H-3-2011-130-lap

Identifier Type: -

Identifier Source: org_study_id