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

The recruitment status of this study is unknown. The completion date has passed and the status has not been verified in more than two years.
Verified April 2008 by McGill University Health Center.
Recruitment status was:  Not yet recruiting
Sponsor:
ClinicalTrials.gov Identifier:
NCT00640380
First Posted: March 21, 2008
Last Update Posted: April 11, 2008
The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
Information provided by:
McGill University Health Center
  Purpose
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.

Condition Intervention
Shoulder Surgery Other: Nerve stimulation Other: Loss of resistance to air

Study Type: Interventional
Study Design: Allocation: Randomized
Intervention Model: Single Group Assignment
Masking: Single (Outcomes Assessor)
Official Title: A Comparison Between Neurostimulation and Loss of Resistance for Cervical Paravertebral Blocks

Further study details as provided by McGill University Health Center:

Primary Outcome Measures:
  • Success [ Time Frame: 8 months ]

Secondary Outcome Measures:
  • performance time, onset time, side effects [ Time Frame: 8 months ]

Estimated Enrollment: 90
Study Start Date: May 2008
Estimated Study Completion Date: October 2008
Estimated Primary Completion Date: October 2008 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
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

  Eligibility

Information from the National Library of Medicine

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Ages Eligible for Study:   18 Years to 70 Years   (Adult, Senior)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Criteria

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
  Contacts and Locations
Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT00640380


Contacts
Contact: De QH Tran, MD, FRCPC (514)934-1934 ext 43261 de_tran@hotmail.com
Contact: Roderick J Finlayson, MD, FRCPC (514)934-1934 ext 43261

Locations
Canada, Quebec
Montreal General Hospital Not yet recruiting
Montreal, Quebec, Canada, H3G-1A4
Contact: De QH Tran, MD, FRCPC    (514)934-1934 ext 43261    de_tran@hotmail.com   
Contact: Roderick J Finlayson, MD, FRCPC    (514)934-1934 ext 43261      
Sponsors and Collaborators
McGill University Health Center
Investigators
Principal Investigator: De QH Tran, MD, FRCPC McGill University
  More Information

Responsible Party: De QH Tran, Anesthesia Department
ClinicalTrials.gov Identifier: NCT00640380     History of Changes
Other Study ID Numbers: GEN-07-052
First Submitted: March 17, 2008
First Posted: March 21, 2008
Last Update Posted: April 11, 2008
Last Verified: April 2008

Keywords provided by McGill University Health Center:
cervical
paravertebral
block