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

NCT00640380 | Unknown

• 1 other identifier: GEN-07-052
• Study Type: interventional
• Target: 90
• Locations: 1 country
• Sites: 1

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.

Conditions

Shoulder Surgery

Keywords

cervical; paravertebral; block

Outcome Measures

Primary Outcomes (1)

• Success

  8 months

Secondary Outcomes (1)

• performance time, onset time, side effects

  8 months

Study Arms (2)

1

EXPERIMENTAL

CPVB with NS

Other: Nerve stimulation

2

ACTIVE COMPARATOR

CPVB with LOR

Other: Loss of resistance to air

Interventions

Nerve stimulation OTHER

CPVB with NS

1

Loss of resistance to air OTHER

CPVB with LOR

2

Eligibility Criteria

• Age: 18 Years - 70 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

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

You may not qualify if:

• 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

Sponsors & Collaborators

• McGill University Health Centre/Research Institute of the McGill University Health Centre: lead

Study Sites (1)

Montreal General Hospital

Montreal, Quebec, H3G-1A4, Canada

Location

MeSH Terms

Conditions

Bites and Stings

Condition Hierarchy (Ancestors)

Poisoning; Chemically-Induced Disorders; Wounds and Injuries

Study Officials

• De QH Tran, MD, FRCPC

  McGill University

  PRINCIPAL INVESTIGATOR

Central Study Contacts

De QH Tran, MD, FRCPC

CONTACT

(514)934-1934; de_tran@hotmail.com

Roderick J Finlayson, MD, FRCPC

CONTACT

(514)934-1934

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: SINGLE
• Who Masked: OUTCOMES ASSESSOR
• Intervention Model: SINGLE GROUP
• Sponsor Type: OTHER

Study Record Dates

• First Submitted: March 17, 2008
• First Posted: March 21, 2008
• Study Start: May 1, 2008
• Primary Completion: October 1, 2008
• Study Completion: October 1, 2008
• Last Updated: April 11, 2008

Record last verified: 2008-04

Locations

CA (1)