A Comparison Between Neurostimulation and Loss of Resistance for Cervical Paravertebral Blocks

April 7, 2008 updated by: McGill University Health Centre/Research Institute of the McGill University Health Centre
Cervical paravertebral blocks (CPVBs) target the brachial plexus from a puncture site situated in the posterior aspect of the neck and represent an alternative to interscalene blocks (ISBs) for shoulder and proximal humeral surgery. Randomized controlled trials comparing CPVB and ISB have found no significant differences in success rate, onset and offset times. Because of the reliability of their cutaneous landmarks, CPVBs have become part of the investigators' standard practice. With this approach, the brachial approach can be identified either with loss of resistance to air (LOR) or nerve stimulation (NS). While some authors have used only LOR and reported good success rates, others have hypothesized that NS may increase the reliability of the block. In the proposed study, for the first time, the 2 methods will be formally compared.

Study Overview

Status

Unknown

Conditions

Intervention / Treatment

Study Type

Interventional

Enrollment (Anticipated)

90

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

  • Canada
    • Quebec
      • Montreal, Quebec, Canada, H3G-1A4
        • Montreal 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

18 years to 70 years (Adult, Older Adult)

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Description

Inclusion Criteria are:

  • age between 18 and 70 years
  • American Society of Anesthesiologists classification 1-3
  • body mass index between 20 and 28

Exclusion criteria are:

  • adults who are unable to give their own consent
  • pre-existing obstructive or restrictive lung disease (assessed by history and physical examination)
  • pre-existing neuropathy (assessed by history and physical examination)
  • coagulopathy (assessed by history and physical examination and, if deemed clinically necessary, by blood work up ie platelets≤ 100, International Normalized Ratio≥ 1.4 or prothrombin time ≥ 50)
  • renal failure (assessed by history and physical examination and, if deemed clinically necessary, by blood work up ie creatinine≥ 100)
  • hepatic failure (assessed by history and physical examination and, if deemed clinically necessary, by blood work up ie transaminases≥ 100)
  • allergy to local anesthetic agents (LA)
  • pregnancy
  • prior cervical spine surgery

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

  • Allocation: Randomized
  • Interventional Model: Single Group Assignment
  • Masking: Single

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
Experimental: 1
CPVB with NS
Other: Nerve stimulation
CPVB with NS
Active Comparator: 2
CPVB with LOR
Other: Loss of resistance to air
CPVB with LOR

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Time Frame
Success
Time Frame: 8 months
8 months

Secondary Outcome Measures

Outcome Measure
Time Frame
performance time, onset time, side effects
Time Frame: 8 months
8 months

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

McGill University Health Centre/Research Institute of the McGill University Health Centre

Investigators

  • Principal Investigator: De QH Tran, MD, FRCPC, McGill 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

May 1, 2008

Primary Completion (Anticipated)

October 1, 2008

Study Completion (Anticipated)

October 1, 2008

Study Registration Dates

First Submitted

March 17, 2008

First Submitted That Met QC Criteria

March 20, 2008

First Posted (Estimate)

March 21, 2008

Study Record Updates

Last Update Posted (Estimate)

April 11, 2008

Last Update Submitted That Met QC Criteria

April 7, 2008

Last Verified

April 1, 2008

More Information

Terms related to this study

Keywords

Other Study ID Numbers

  • GEN-07-052

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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