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

Shoulder Surgery Clinical Trial

Official title:

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

Clinical Trial Details — Status: Not yet recruiting

Administrative data

• NCT number: NCT00640380
• Other study ID #: GEN-07-052
• Status: Not yet recruiting
• Phase: N/A
• First received: March 17, 2008
• Last updated: April 7, 2008
• Start date: May 2008
• Est. completion date: October 2008

Study information

• Verified date: April 2008
• Source: McGill University Health Center
• Contact: De QH Tran, MD, FRCPC
• Phone: (514)934-1934
• Email: de_tran[@]hotmail.com
• Is FDA regulated: No
• Health authority: Canada: Ethics Review Committee
• Study type: Interventional

Clinical Trial 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.

Recruitment information / eligibility

• Status: Not yet recruiting
• Enrollment: 90
• Est. completion date: October 2008
• Est. primary completion date: October 2008
• Accepts healthy volunteers: No
• Gender: Both
• Age group: 18 Years to 70 Years

Eligibility

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 Design

Allocation: Randomized, Endpoint Classification: Efficacy Study, Intervention Model: Single Group Assignment, Masking: Single Blind (Outcomes Assessor)

Related Conditions & MeSH terms

• Shoulder Surgery

Intervention

Other:
• Nerve stimulation
CPVB with NS
• Loss of resistance to air
CPVB with LOR

Locations

Country	Name	City	State
Canada	Montreal General Hospital	Montreal	Quebec

Sponsors (1)

Lead Sponsor	Collaborator
McGill University Health Center

Country where clinical trial is conducted

Canada, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Success		8 months	No
Secondary	performance time, onset time, side effects		8 months	No