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

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ClinicalTrials.gov Identifier: NCT00640380
Recruitment Status : Unknown
Verified April 2008 by McGill University Health Center.
Recruitment status was:  Not yet recruiting
First Posted : March 21, 2008
Last Update Posted : April 11, 2008
Sponsor:
Information provided by:
McGill University Health Center

Brief Summary:
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 or disease Intervention/treatment Phase
Shoulder Surgery Other: Nerve stimulation Other: Loss of resistance to air Not Applicable

Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 90 participants
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
Study Start Date : May 2008
Estimated Primary Completion Date : October 2008
Estimated Study Completion Date : October 2008

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



Primary Outcome Measures :
  1. Success [ Time Frame: 8 months ]

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


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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

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

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

Keywords provided by McGill University Health Center:
cervical
paravertebral
block