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

This study has been terminated.
Sponsor:
ClinicalTrials.gov Identifier:
NCT01373593
First Posted: June 15, 2011
Last Update Posted: June 20, 2012
The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
Information provided by:
Rigshospitalet, Denmark
  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
Intervention Model: Crossover Assignment
Masking: Double (Participant, 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:


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 ]

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

Information from the National Library of Medicine

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Ages Eligible for Study:   18 Years and older   (Adult, Senior)
Sexes Eligible for Study:   All
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
Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT01373593


Locations
Denmark
Rigshospitalet
Copenhagen, Denmark
Sponsors and Collaborators
Rigshospitalet, Denmark
  More Information

Publications automatically indexed to this study by ClinicalTrials.gov Identifier (NCT Number):
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
First Submitted: June 8, 2011
First Posted: June 15, 2011
Last Update Posted: June 20, 2012
Last Verified: January 2011

Keywords provided by Rigshospitalet, Denmark:
persistent postherniorrhaphy pain

Additional relevant MeSH terms:
Lidocaine
Anesthetics, Local
Anesthetics
Central Nervous System Depressants
Physiological Effects of Drugs
Sensory System Agents
Peripheral Nervous System Agents
Anti-Arrhythmia Agents
Voltage-Gated Sodium Channel Blockers
Sodium Channel Blockers
Membrane Transport Modulators
Molecular Mechanisms of Pharmacological Action