Ultrasound Guided Blocks of the Iliohypogastric and Ilioinguinal Nerves in Persistent Postherniorrhaphy Pain Patients

This study has been terminated.

Sponsor:

Information provided by:

Rigshospitalet, Denmark

ClinicalTrials.gov Identifier:

NCT01373593

First received: June 8, 2011

Last updated: June 19, 2012

Last verified: January 2011

History of Changes

Purpose

In this controlled study the investigators will examine the analgesic and sensory effects of ultrasound-guided blocks of the iliohypogastric and ilioinguinal nerves with lidocaine in persistent postherniorrhaphy pain patients.

Condition	Intervention	Phase
Pain	Drug: lidocaine Drug: Placebo	Phase 4

Study Type:	Interventional
Study Design:	Allocation: Randomized Endpoint Classification: Efficacy Study Intervention Model: Crossover Assignment Masking: Double Blind (Subject, Investigator) Primary Purpose: Diagnostic
Official Title:	Ultrasound Guided Blocks of the Iliohypogastric and Ilioinguinal Nerves in Persistent Postherniorrhaphy Pain Patients

Resource links provided by NLM:

Drug Information available for: Lidocaine hydrochloride Lidocaine

U.S. FDA Resources

Further study details as provided by Rigshospitalet, Denmark:

Primary Outcome Measures:

changes (lidocaine vs. placebo) in pain perception, sensory mapping and QST compared to pre-block values. [ Time Frame: 20 minutes after the block ] [ Designated as safety issue: No ]

Enrollment:	12
Study Start Date:	January 2011
Study Completion Date:	July 2011
Primary Completion Date:	July 2011 (Final data collection date for primary outcome measure)

Arms	Assigned Interventions
Experimental: lidocaine lidocaine block	Drug: lidocaine
Placebo Comparator: Placebo	Drug: Placebo

Eligibility

Ages Eligible for Study:	18 Years and older
Genders Eligible for Study:	Both
Accepts Healthy Volunteers:	Yes

Criteria

Inclusion Criteria:

patients older than 18 years with severe postherniorrhaphy pain (numerical rating scale [NRS] > 6) for more than 6 month

Exclusion Criteria:

known amide local anesthetic drug allergy
recurrent hernia

Contacts and Locations

Please refer to this study by its ClinicalTrials.gov identifier: NCT01373593

Locations

Denmark
Rigshospitalet
Copenhagen, Denmark

Sponsors and Collaborators

Rigshospitalet, Denmark

More Information

No publications provided by Rigshospitalet, Denmark

Additional publications automatically indexed to this study by ClinicalTrials.gov Identifier (NCT Number):

Bischoff JM, Koscielniak-Nielsen ZJ, Kehlet H, Werner MU. Ultrasound-guided ilioinguinal/iliohypogastric nerve blocks for persistent inguinal postherniorrhaphy pain: a randomized, double-blind, placebo-controlled, crossover trial. Anesth Analg. 2012 Jun;114(6):1323-9. Epub 2012 Mar 30.

Responsible Party:	Joakim Bischoff, Rigshospitalet, Blegdamsvej 9, 2100 Copenhagen, Danmark
ClinicalTrials.gov Identifier:	NCT01373593 History of Changes
Other Study ID Numbers:	H-1-2010-116
Study First Received:	June 8, 2011
Last Updated:	June 19, 2012
Health Authority:	Denmark: Danish Dataprotection Agency Denmark: Ethics Committee

Keywords provided by Rigshospitalet, Denmark:

persistent postherniorrhaphy pain

Additional relevant MeSH terms:

Lidocaine
Anesthetics, Local
Anesthetics
Central Nervous System Depressants
Physiological Effects of Drugs
Pharmacologic Actions

Sensory System Agents
Peripheral Nervous System Agents
Central Nervous System Agents
Therapeutic Uses
Anti-Arrhythmia Agents
Cardiovascular Agents

ClinicalTrials.gov processed this record on May 16, 2013

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