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

NCT ID: NCT00640380

Last Updated: 2008-04-11

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

UNKNOWN

Clinical Phase

NA

Total Enrollment

90 participants

Study Classification

INTERVENTIONAL

Study Start Date

2008-05-31

Study Completion Date

2008-10-31

Brief Summary

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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.

Detailed Description

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Conditions

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Shoulder Surgery

Keywords

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cervical paravertebral block

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

SINGLE_GROUP

Blinding Strategy

SINGLE

Outcome Assessors

Study Groups

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1

CPVB with NS

Group Type EXPERIMENTAL

Nerve stimulation

Intervention Type OTHER

CPVB with NS

2

CPVB with LOR

Group Type ACTIVE_COMPARATOR

Loss of resistance to air

Intervention Type OTHER

CPVB with LOR

Interventions

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Nerve stimulation

CPVB with NS

Intervention Type OTHER

Loss of resistance to air

CPVB with LOR

Intervention Type OTHER

Eligibility Criteria

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Inclusion Criteria

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

Exclusion Criteria

* 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
Minimum Eligible Age

18 Years

Maximum Eligible Age

70 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No

Sponsors

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

OTHER

Sponsor Role lead

Responsible Party

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Anesthesia Department

Principal Investigators

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De QH Tran, MD, FRCPC

Role: PRINCIPAL_INVESTIGATOR

McGill University

Locations

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Montreal General Hospital

Montreal, Quebec, Canada

Site Status

Countries

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Canada

Central Contacts

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De QH Tran, MD, FRCPC

Role: CONTACT

Phone: (514)934-1934

Email: [email protected]

Roderick J Finlayson, MD, FRCPC

Role: CONTACT

Phone: (514)934-1934

Facility Contacts

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De QH Tran, MD, FRCPC

Role: primary

Roderick J Finlayson, MD, FRCPC

Role: backup

Other Identifiers

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GEN-07-052

Identifier Type: -

Identifier Source: org_study_id