NCT00827658

Brief Summary

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.

Trial Health

57
Monitor

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
127

participants targeted

Target at P50-P75 for not_applicable

Timeline
Completed

Started Feb 2008

Geographic Reach
1 country

1 active site

Status
terminated

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

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Study Timeline

Key milestones and dates

Study Start

First participant enrolled

February 1, 2008

Completed
12 months until next milestone

First Submitted

Initial submission to the registry

January 21, 2009

Completed
2 days until next milestone

First Posted

Study publicly available on registry

January 23, 2009

Completed
5 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

July 1, 2009

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

July 1, 2009

Completed
Last Updated

May 14, 2018

Status Verified

May 1, 2018

Enrollment Period

1.4 years

First QC Date

January 21, 2009

Last Update Submit

May 8, 2018

Conditions

Keywords

anesthesia, localulnar nervehandsurgery, plasticblindedrandomizedprospectivelocal anesthesiavolar wrist blockhypothenar palm blockhand surgery

Outcome Measures

Primary Outcomes (1)

  • Primary outcome is efficacy of sensory anesthesia and analgesia

    15-45 minutes

Secondary Outcomes (1)

  • Secondary outcome is patient perceived discomfort with block

    15-45 Minutes

Study Arms (2)

Hypothenar Palm block

ACTIVE COMPARATOR

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.

Procedure: Hypothenar Palm block

Volar Wrist Block

ACTIVE COMPARATOR

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.

Procedure: Volar Wrist Block

Interventions

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)

Volar Wrist Block

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)

Hypothenar Palm block

Eligibility Criteria

Age18 Years+
Sexall
Healthy VolunteersYes
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • 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.

You may not qualify if:

  • 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

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Hamilton General Hospital

Hamilton, Ontario, Canada

Location

Study Officials

  • Stuart Martin

    McMaster University

    PRINCIPAL INVESTIGATOR

Study Design

Study Type
interventional
Phase
not applicable
Allocation
RANDOMIZED
Masking
SINGLE
Who Masked
INVESTIGATOR
Purpose
TREATMENT
Intervention Model
SINGLE GROUP
Sponsor Type
OTHER
Responsible Party
SPONSOR

Study Record Dates

First Submitted

January 21, 2009

First Posted

January 23, 2009

Study Start

February 1, 2008

Primary Completion

July 1, 2009

Study Completion

July 1, 2009

Last Updated

May 14, 2018

Record last verified: 2018-05

Locations