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

Tracking Information
First Received Date ^ICMJE	June 8, 2011
Last Updated Date	June 19, 2012
Start Date ^ICMJE	January 2011
Primary Completion Date	July 2011 (final data collection date for primary outcome measure)
Current Primary Outcome Measures ^ICMJE (submitted: June 14, 2011)	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 ]
Original Primary Outcome Measures ^ICMJE	Same as current
Change History	Complete list of historical versions of study NCT01373593 on ClinicalTrials.gov Archive Site
Current Secondary Outcome Measures ^ICMJE	Not Provided
Original Secondary Outcome Measures ^ICMJE	Not Provided
Current Other Outcome Measures ^ICMJE	Not Provided
Original Other Outcome Measures ^ICMJE	Not Provided

Descriptive Information
Brief Title ^ICMJE	Ultrasound Guided Blocks of the Iliohypogastric and Ilioinguinal Nerves in Persistent Postherniorrhaphy Pain Patients
Official Title ^ICMJE	Ultrasound Guided Blocks of the Iliohypogastric and Ilioinguinal Nerves in Persistent Postherniorrhaphy Pain Patients
Brief Summary	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.
Detailed Description	Not Provided
Study Type ^ICMJE	Interventional
Study Phase	Phase 4
Study Design ^ICMJE	Allocation: Randomized Endpoint Classification: Efficacy Study Intervention Model: Crossover Assignment Masking: Double Blind (Subject, Investigator) Primary Purpose: Diagnostic
Condition ^ICMJE	Pain
Intervention ^ICMJE	Drug: lidocaine Drug: Placebo
Study Arm (s)	Experimental: lidocaine lidocaine block Intervention: Drug: lidocaine Placebo Comparator: Placebo Intervention: Drug: Placebo
Publications *	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.
* Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.

Recruitment Information
Recruitment Status ^ICMJE	Terminated
Enrollment ^ICMJE	12
Completion Date	July 2011
Primary Completion Date	July 2011 (final data collection date for primary outcome measure)
Eligibility Criteria ^ICMJE	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
Gender	Both
Ages	18 Years and older
Accepts Healthy Volunteers	Yes
Contacts ^ICMJE	Contact information is only displayed when the study is recruiting subjects
Location Countries ^ICMJE	Denmark

Administrative Information
NCT Number ^ICMJE	NCT01373593
Other Study ID Numbers ^ICMJE	H-1-2010-116
Has Data Monitoring Committee	No
Responsible Party	Joakim Bischoff, Rigshospitalet, Blegdamsvej 9, 2100 Copenhagen, Danmark
Study Sponsor ^ICMJE	Rigshospitalet, Denmark
Collaborators ^ICMJE	Not Provided
Investigators ^ICMJE	Not Provided
Information Provided By	Rigshospitalet, Denmark
Verification Date	January 2011
^ICMJE Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP

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