- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT00827658
Ulnar Nerve Block for Procedural Anesthesia - Wrist Versus Palm
May 8, 2018 updated by: Hamilton Health Sciences Corporation
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 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.
Study Overview
Status
Terminated
Conditions
Intervention / Treatment
Study Type
Interventional
Enrollment (Actual)
127
Phase
- Not Applicable
Contacts and Locations
This section provides the contact details for those conducting the study, and information on where this study is being conducted.
Study Locations
-
-
Ontario
-
Hamilton, Ontario, Canada
- Hamilton General Hospital
-
-
Participation Criteria
Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.
Eligibility Criteria
Ages Eligible for Study
14 years and older (Adult, Older Adult)
Accepts Healthy Volunteers
No
Genders Eligible for Study
All
Description
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
Study Plan
This section provides details of the study plan, including how the study is designed and what the study is measuring.
How is the study designed?
Design Details
- Primary Purpose: Treatment
- Allocation: Randomized
- Interventional Model: Single Group Assignment
- Masking: Single
Arms and Interventions
Participant Group / Arm |
Intervention / Treatment |
|---|---|
|
Active Comparator: Hypothenar Palm block
Hypothenar Palmar block group.
Local anesthetic is placed at this location in this study group.
The same local composition (Intervention) is used for both study groups.
The trial is a comparison of location not the Intervention.
|
Injection at Hook of the Hamate on Palmar surface 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 anesthetic is placed at this location in this study group.
The same local composition (Intervention) is used for both study groups.
The trial is a comparison of location not the Intervention.
|
Injection medial to Flexor Carpi Ulnaris Tendon at volar proximal wrist crease Local Block - total 3 cc injection (1.5 cc 1% plain lidocaine and 1.5 cc of 0.25% bupivicaine) |
What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Time Frame |
|---|---|
|
Primary outcome is efficacy of sensory anesthesia and analgesia
Time Frame: 15-45 minutes
|
15-45 minutes
|
Secondary Outcome Measures
Outcome Measure |
Time Frame |
|---|---|
|
Secondary outcome is patient perceived discomfort with block
Time Frame: 15-45 Minutes
|
15-45 Minutes
|
Collaborators and Investigators
This is where you will find people and organizations involved with this study.
Collaborators
Investigators
- Principal Investigator: Stuart Martin, McMaster University
Study record dates
These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.
Study Major Dates
Study Start
February 1, 2008
Primary Completion (Actual)
July 1, 2009
Study Completion (Actual)
July 1, 2009
Study Registration Dates
First Submitted
January 21, 2009
First Submitted That Met QC Criteria
January 22, 2009
First Posted (Estimate)
January 23, 2009
Study Record Updates
Last Update Posted (Actual)
May 14, 2018
Last Update Submitted That Met QC Criteria
May 8, 2018
Last Verified
May 1, 2018
More Information
Terms related to this study
Keywords
Other Study ID Numbers
- McMaster 08-053
This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.
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