Ulnar Nerve Block for Procedural Anesthesia - Wrist Versus Palm

The recruitment status of this study is unknown because the information has not been verified recently.
Verified January 2009 by McMaster University.
Recruitment status was  Recruiting
Sponsor:
Collaborator:
McMaster University
Information provided by:
McMaster University
ClinicalTrials.gov Identifier:
NCT00827658
First received: January 21, 2009
Last updated: January 22, 2009
Last verified: January 2009
  Purpose

Ulnar nerve blockade is necessary for sensory anesthesia and analgesia in the hand during minor procedures. The course of the ulnar nerve in the forearm, wrist, and hand is predictable and has low variability. However even with known anatomic location and landmarks, ulnar nerve blocks at the wrist frequently are inadequate for procedural anesthesia. The antebrachial fascia at the wrist acts as a barrier to local infiltration. Since the fascia can not be visualized or palpated, it is commonly is not penetrated, resulting in an inadequate block. Furthermore at the level of the wrist the ulnar artery lies in close proximity to the nerve and there is potential for arterial puncture while attempting injection for volar wrist block. The palmar ulnar nerve block is an injection distal to the hook of the hamate in the thenar eminence which avoids the ulnar artery and antebrachial fascia. This block has been used successfully for many years in clinical practice but has not been assessed or compared in a research study. The purpose of this study is to assess the validity of using a palmar ulnar nerve block for procedures in the hand as compared to the standard volar wrist ulnar nerve block.


Condition Intervention
Hand Surgery
Procedure: Local Block

Study Type: Interventional
Study Design: Allocation: Randomized
Endpoint Classification: Efficacy Study
Intervention Model: Single Group Assignment
Masking: Single Blind (Investigator)
Primary Purpose: Treatment
Official Title: Ulnar Nerve Block for Procedural Anesthesia - Wrist Versus Palm

Further study details as provided by McMaster University:

Primary Outcome Measures:
  • Primary outcome is efficacy of sensory anesthesia and analgesia [ Time Frame: 15-45 minutes ] [ Designated as safety issue: No ]

Secondary Outcome Measures:
  • Secondary outcome is patient perceived discomfort with block [ Time Frame: 15-45 Minutes ] [ Designated as safety issue: No ]

Estimated Enrollment: 246
Study Start Date: February 2008
Estimated Study Completion Date: December 2009
Estimated Primary Completion Date: December 2009 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
Active Comparator: Hypothenar Palm block
Hypothenar Palmar block group. Local is placed at this location in this study arm. The same local composition (Intervention) is used for both study arms. The trial is a comparison of location not the Intervention.
Procedure: Local Block
total 3 cc injection (1.5 cc 1% plain lidocaine and 1.5 cc of 0.25% bupivicaine)
Active Comparator: Volar Wrist Block
Volar Wrist block group. Local is placed at this location in this study arm. The same local composition (Intervention) is used for both study arms. The trial is a comparison of location not the Intervention.
Procedure: Local Block
total 3 cc injection (1.5 cc 1% plain lidocaine and 1.5 cc of 0.25% bupivicaine)

  Eligibility

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

Inclusion Criteria:

  • any individual who can give informed consent and is scheduled for elective hand procedures by the PI necessitating an Ulnar nerve block of the hand.

Exclusion Criteria:

  • patients unable to give informed consent
  • patients with previous or ongoing ulnar nerve deficits or neuropathy
  • patients undergoing Guyon's canal decompression
  • patients who can not comprehend or cooperate with assessment testing
  • patients with abnormal two point discrimination (> 6 mm at the test location) prior to the nerve block
  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: NCT00827658

Contacts
Contact: Stuart Martin 905-572-6226 smartin@mcmaster.ca
Contact: Annika Card 905-526-1948 annika@quadrant.net

Locations
Canada, Ontario
Hamilton General Hospital Recruiting
Hamilton, Ontario, Canada
Contact: Sonia Giangregorio-Campanella       giangreg@hhsc.ca   
Principal Investigator: Stuart Martin         
Sub-Investigator: Annika Card         
Sponsors and Collaborators
Hamilton Health Sciences Corporation
McMaster University
Investigators
Principal Investigator: Stuart Martin McMaster University
  More Information

No publications provided

Responsible Party: Dr. S. Martin, Division of Plastic Surgery, Department of Surgery, McMaster University
ClinicalTrials.gov Identifier: NCT00827658     History of Changes
Other Study ID Numbers: McMaster 08-053
Study First Received: January 21, 2009
Last Updated: January 22, 2009
Health Authority: Canada: Ethics Review Committee

Keywords provided by McMaster University:
surgery, plastic
anesthesia, local
ulnar nerve
hand
blinded
randomized
prospective
local anesthesia
volar wrist block
hypothenar palm block
hand surgery

Additional relevant MeSH terms:
Anesthetics
Central Nervous System Depressants
Physiological Effects of Drugs
Pharmacologic Actions
Central Nervous System Agents
Therapeutic Uses

ClinicalTrials.gov processed this record on August 21, 2014