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
  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:


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
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

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):
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 July 29, 2014