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

NCT02065219 · Status: COMPLETED · Phase: PHASE3 · Type: INTERVENTIONAL · Enrollment: 20

Last updated 2016-11-28

No results posted yet for this study

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 open groin hernia repair.

Conditions

Interventions

DRUG

Bupivacaine

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

DRUG

Placebo

10 ml 0.9% physiological saline deposited by ultra-sound guidance around the spermatic cord

Sponsors & Collaborators

  • Rigshospitalet, Denmark

    collaborator OTHER

  • University of Copenhagen

    lead OTHER

Principal Investigators

  • Mads U Werner, MD · Multidisciplinary Pain Center, Neuroscience Center, Rigshospitalet, Copenhagen University Hospital, DENMARK

  • Henrik Kehlet, MD · Section of Surgical Pathophysiology, Juliane Marie Center, Copenhagen University Hospital, DENMARK

Study Design

Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
QUADRUPLE
Model
CROSSOVER

Eligibility

Min Age
18 Years
Sex
ALL
Healthy Volunteers
Yes

Timeline & Regulatory

Start
2013-11-30
Primary Completion
2014-04-30
Completion
2015-05-31

Countries

  • Denmark

Study Locations

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Entities

Drugs
Diseases

Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT02065219 on ClinicalTrials.gov