NCT00221884

Brief Summary

Many patients undergoing surgery on their hand receive a form of anesthetic called "axillary brachial plexus block". This involves the injection of local anesthetic (freezing medication) around the nerves that supply the upper limb, which are located in the arm pit. The technique currently used by physicians performing this procedure is far from perfect, and in up to 1 of every 5 patients it does not work well enough to allow surgery, and a different form of anesthetic may need to be used. In an attempt to improve these results, we have recently developed a new technique, using ultrasound imaging to "see" the nerves prior to giving the injection. Our initial results are very promising, implying that this may be a highly successful and safe approach. The purpose of this study is to determine if this technique is indeed more successful. In order to do that, we will ask 110 patients for their participation. They will be divided in two groups, at random. One group will receive the standard technique (transarterial, using a small needle to find the artery that is close to the nerves). The other group will receive the injection after identifying the nerves with ultrasound imaging. They will all receive the same type of medication, and they will be tested every 5 minutes for half an hour to determine if the block has been successful, according to pre-established criteria. Their pain control will be assessed after the surgery and they will be called 24 hours and 1 week after the surgery to assess their recovery and rule out any possible complications.

Trial Health

87
On Track

Trial Health Score

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

Timeline
Completed

Started Aug 2002

Typical duration for not_applicable

Geographic Reach
1 country

1 active site

Status
completed

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

August 1, 2002

Completed
3 years until next milestone

Study Completion

Last participant's last visit for all outcomes

August 1, 2005

Completed
2 months until next milestone

First Submitted

Initial submission to the registry

September 20, 2005

Completed
2 days until next milestone

First Posted

Study publicly available on registry

September 22, 2005

Completed
Last Updated

December 5, 2008

Status Verified

September 1, 2005

First QC Date

September 20, 2005

Last Update Submit

December 4, 2008

Conditions

Interventions

UltrasoundPROCEDURE

Eligibility Criteria

Age18 Years - 80 Years
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • ASA PS 1-3
  • to 80 years of age
  • to 100 kg of body weight
  • elective upper extremity procedure amenable to brachial plexus block
  • estimated surgical time \> 1 hr

You may not qualify if:

  • Any medical contraindication to brachial plexus block ( allergy to local anesthetics, coagulopathy, loco-regional malignancy or infection, neurological deficit in the area to be blocked, severe respiratory disease)
  • Inability to read, write or speak English
  • Chronic pain longer than 6 months
  • Chronic opioid use
  • History of drug abuse

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

University Health Network

Toronto, Ontario, M5T2S8, Canada

Location

MeSH Terms

Interventions

High-Energy Shock Waves

Intervention Hierarchy (Ancestors)

Ultrasonic WavesSoundRadiation, NonionizingRadiationPhysical Phenomena

Study Officials

  • Vincent WS Chan, MD

    University Health Network, Toronto

    PRINCIPAL INVESTIGATOR

Study Design

Study Type
interventional
Phase
not applicable
Allocation
RANDOMIZED
Masking
DOUBLE
Intervention Model
PARALLEL
Sponsor Type
OTHER

Study Record Dates

First Submitted

September 20, 2005

First Posted

September 22, 2005

Study Start

August 1, 2002

Study Completion

August 1, 2005

Last Updated

December 5, 2008

Record last verified: 2005-09

Locations