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Effects of Technique on the Local Anesthetic Dose Required for Interscalene Brachial Plexus Block

NCT ID: NCT00731146

Last Updated: 2008-08-08

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

80 participants

Study Classification

INTERVENTIONAL

Study Start Date

2008-08-31

Study Completion Date

2009-07-31

Brief Summary

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Interscalene brachial plexus block (ISBPB) is a common nerve block given to patients who are undergoing shoulder surgery. This block has a low, but still significant, rate of complications. Reducing the volume of local anesthetic given during the block may allow some of these complications to be avoided. Participants will be randomly assigned to a group to undergo ISBPB under ultrasound or nerve stimulator guidance. Each group will initially receive 10mL of local anesthetic. The volume used for each subsequent patient depends upon the success or failure of the previous patient's block - a failure will cause the volume given to increase by 2.5mL, while a success will cause the volume to decrease by the same amount. We hypothesize that the minimum effective anesthetic volume in 50% of patients will be significantly lower in the ultrasound guided group than in the nerve stimulator group. We further hypothesize that this lower volume will lead to a decreased rate of complications.

Detailed Description

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This will be a randomized, single-blind, up-down sequential allocation study. Patients will be randomly assigned to one of two groups, and receive either an ultrasound-guided or nerve-stimulator guided interscalene brachial plexus block. The initial local anesthetic volume in both groups will be 10mL. The outcome of each patient's block will determine the dose for the subsequent patient. When an effective ISBPB is observed, as defined by a NRS (patient-rated pain on a scale from 0 to 10) rating of 0 within 30 minutes post-surgery, the volume of local anesthetic solution used for the next patient will be decreased by 2.5mL. Conversely, when an ineffective ISBPB is observed, the volume of local anesthetic used for the next patient will be increased by 2.5mL.

The goal of this study is to determine the minimum effective anesthetic volume of ropivacaine 0.5% providing analgesia in patients when using either ultrasound or a nerve stimulator to guide placement of the block. The primary outcome measure will be the pain score of the patient on a numeric rating score during the 30 minutes after surgery.

A number of previous studies have suggested that ultrasound-guidance is beneficial for peripheral nerve blocks in terms of block performance time, success rates, and block quality. Some studies have also shown that ultrasound-guidance can reduce the volume of local anesthetic needed to perform a successful block. This study may reveal that less local anesthetic is needed under ultrasound guidance than under nerve stimulator, which may potentially reduce some of the common complications of ISBPB.

We hypothesize that ISBPB done under ultrasound guidance will have a lower minimum effective local anesthetic volume than ISBPB done under nerve stimulation. Further, we hypothesize that the lower volume will reduce the incidence of some of the complications of ISBPB.

Using lower volumes of local anesthetic while still maintaining effective analgesia may reduce some of the common complications of ISBPB. It may also allow this beneficial analgesic technique to be given to patients with some respiratory risk factors who are currently unable to receive it.

Conditions

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Arthroscopic Shoulder Surgery

Keywords

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Interscalene Brachial Plexus Block Regional Anesthesia Ultrasound guided peripheral nerve block Minimum Effective Anesthetic Volume Nerve Stimulator guided peripheral nerve block

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

Primary Study Purpose

TREATMENT

Blinding Strategy

DOUBLE

Participants Outcome Assessors

Study Groups

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1 - Ultrasound

Participants will receive an ultrasound guided interscalene brachial plexus block

Group Type ACTIVE_COMPARATOR

Ultrasound Minimum Effective Anesthetic Volume

Intervention Type OTHER

Each sequential participant in this group will be assigned a dose based on the success or failure of the previous participant's block. The starting dose will be 10mL of 0.5% ropivacaine. Each success will decrease the dose by 2.5mL and each failure will subsequently increase the dose by 2.5mL.

2 - Nerve Stimulator

Participants will receive a nerve stimulator guided interscalene brachial plexus block

Group Type ACTIVE_COMPARATOR

Nerve Stimulator Minimum Effective Anesthetic Volume

Intervention Type OTHER

Each sequential participant in this group will be assigned a dose based on the success or failure of the previous participant's block. The starting dose will be 10mL of 0.5% ropivacaine. Each success will decrease the dose by 2.5mL and each failure will subsequently increase the dose by 2.5mL.

Interventions

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Ultrasound Minimum Effective Anesthetic Volume

Each sequential participant in this group will be assigned a dose based on the success or failure of the previous participant's block. The starting dose will be 10mL of 0.5% ropivacaine. Each success will decrease the dose by 2.5mL and each failure will subsequently increase the dose by 2.5mL.

Intervention Type OTHER

Nerve Stimulator Minimum Effective Anesthetic Volume

Each sequential participant in this group will be assigned a dose based on the success or failure of the previous participant's block. The starting dose will be 10mL of 0.5% ropivacaine. Each success will decrease the dose by 2.5mL and each failure will subsequently increase the dose by 2.5mL.

Intervention Type OTHER

Eligibility Criteria

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Inclusion Criteria

* Patients receiving interscalene brachial plexus block for arthroscopic shoulder surgery

Exclusion Criteria

* ASA \>III, and body mass index (BMI) \>35, pre-existing chronic obstructive pulmonary disease (COPD), unstable asthma, psychiatric history, renal or hepatic impairment, allergy to ropivacaine, and opioid tolerance (\>30 mg oral morphine or equivalent per day).
Minimum Eligible Age

18 Years

Maximum Eligible Age

80 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No

Sponsors

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Sunnybrook Health Sciences Centre

OTHER

Sponsor Role lead

Responsible Party

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Sunnybrook Health Sciences Centre

Principal Investigators

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Colin J McCartney, MD

Role: PRINCIPAL_INVESTIGATOR

Sunnybrook Health Sciences Centre

Locations

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Sunnybrook Health Sciences Centre

Toronto, Ontario, Canada

Site Status RECRUITING

Countries

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Canada

Central Contacts

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Colin J McCartney, MD

Role: CONTACT

Phone: 416-480-6100

Email: [email protected]

Facility Contacts

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Colin J McCartney, MD

Role: primary

Other Identifiers

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SHSCA02

Identifier Type: -

Identifier Source: org_study_id