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The Effect of Interscalene Peripheral Nerve Block With 0.25% Bupivacaine vs 0.125% Bupivacaine on Lung Function

NCT ID: NCT01429584

Last Updated: 2013-12-19

Study Results

Results available

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Basic Information

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Recruitment Status

COMPLETED

Clinical Phase

NA

Total Enrollment

30 participants

Study Classification

INTERVENTIONAL

Study Start Date

2008-05-31

Study Completion Date

2010-02-28

Brief Summary

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Peripheral nerve blocks are used to provide post-operative pain relief. Nerve blocks in the neck, in the interscalene area, provide pain relief after shoulder surgery but can cause temporary weakness or paralysis of the diaphragm. The investigators hypothesized that a lower concentration of bupivacaine would cause less weakness of the diaphragm but still provide good pain relief. Lung function and pain control was studied after interscalene peripheral nerve block with 20 milliliters of 0.25% bupivacaine or 0.125% bupivacaine.

Detailed Description

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Prior to placement of interscalene brachial plexus peripheral nerve block (ISPNB), diaphragm function was assessed using ultrasound as normal, no movement, or paradoxical. Room air pulse oximetry (SpO2) was recorded. Patients were randomized to receive either 0.25% bupivacaine or 0.125% bupivacaine. ISPNB was performed using a coded syringe of the study drug, so that the anesthesiologists performing the nerve block, the patient, and the nurses assessing the patient were blinded as to the concentration. Patients were given a general endotracheal anesthesia for rotator cuff repair, and opioids were administered at the discretion of the attending anesthesiologist. When patients met criteria for PACU discharge, diaphragm function was again assessed using ultrasound and room air SpO2 was recorded.

Conditions

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Diaphragm Paralysis

Keywords

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bupivacaine concentration interscalene nerve block diaphragm function diaphragm weakness

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

Primary Study Purpose

TREATMENT

Blinding Strategy

QUADRUPLE

Participants Caregivers Investigators Outcome Assessors

Study Groups

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0.25% bupivacaine

interscalene nerve block with 0.25% bupivacaine

Group Type ACTIVE_COMPARATOR

interscalene block with 0.125% bupivacaine

Intervention Type DRUG

interscalene block with 20 ml of 0.125% bupivacaine

0.125% bupivacaine

interscalene nerve block with 0.125% bupivacaine

Group Type ACTIVE_COMPARATOR

interscalene nerve block with 0.25% bupivacaine

Intervention Type DRUG

interscalene nerve block performed with 20 ml of 0.25% bupivacaine

Interventions

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interscalene nerve block with 0.25% bupivacaine

interscalene nerve block performed with 20 ml of 0.25% bupivacaine

Intervention Type DRUG

interscalene block with 0.125% bupivacaine

interscalene block with 20 ml of 0.125% bupivacaine

Intervention Type DRUG

Eligibility Criteria

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Inclusion Criteria

* patients presenting for outpatient rotator cuff repair
* adults
* English as the primary language

Exclusion Criteria

* evidence of peripheral nerve damage on affected side
* refusal of peripheral nerve block
* pregnant women
* lung disease, including obstructive sleep apnea
* chronic opioid use
* mental handicap
Minimum Eligible Age

18 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

Yes

Sponsors

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University of Utah

OTHER

Sponsor Role lead

Responsible Party

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Elizabeth Thackeray

Assistant Professor of Anesthesiology

Responsibility Role PRINCIPAL_INVESTIGATOR

Principal Investigators

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Elizabeth Thackeray, MD, MPH

Role: PRINCIPAL_INVESTIGATOR

University of Utah

Jeffrey Swenson, MD

Role: STUDY_DIRECTOR

University of Utah

Locations

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University of Utah Orthopaedics Center

Salt Lake City, Utah, United States

Site Status

Countries

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United States

Other Identifiers

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00026846

Identifier Type: -

Identifier Source: org_study_id