Effect of Interscalene Block on Ventilatory Function

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

COMPLETED

Clinical Phase

PHASE4

Total Enrollment

70 participants

Study Classification

INTERVENTIONAL

Study Start Date

2012-01-31

Study Completion Date

2012-03-31

Brief Summary

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Interscalene block with local anesthetic impairs ventilation (unilateral diaphragmatic dysfunction). Single injection of local anesthetic induced transitory dysfunction (\< 24h). The investigators hypothesized that continuous interscalene block would prolonged ventilatory impairment

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Detailed Description

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Unilateral pulmonary dysfunction occured after interscalene block due to phrenic nerve paralysis. This reduction induced vital capacity alteration and peek flow reduction.Several studies analysed dysfunction recovery duration after single injection using short (lidocaine)or intermediate (ropivacaine, bupivacaine)local anesthetic drug. Because continuous infusion prolonged block duration, phenic nerve may be also prolonged. However no study with continuous interscalene infusion have been performed for this dysfunction.

Conditions

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Respiratory Depression Anesthesia Morbidity Block

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

Primary Study Purpose

TREATMENT

Blinding Strategy

NONE

Study Groups

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Single (no catheter)

ropivacaine single injection : 5 mg/ml 15 ml

Group Type NO_INTERVENTION

No interventions assigned to this group

Continuous infusion

Single injection with continuous injection ropivacaine 2 mg/ml 8 ml/h

Group Type EXPERIMENTAL

ropivacaine 2 mg/ml

Intervention Type DRUG

single

Interventions

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ropivacaine 2 mg/ml

single

Intervention Type DRUG

Eligibility Criteria

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Inclusion Criteria

* surgery : scheduled for elective shoulder surgery
* available for 1 month of follow up
* physical status : 1, 2, 3

Exclusion Criteria

* body mass index \> 35
* contraindication for interscalene block (local sepsis, bleeding, allergy, peripheral neuropathy)
* vital capacity less than 1.5 liters
* cardiac or renal insufficiency
* physical status \>3, pregnant, weigh less than 50 kg

Minimum Eligible Age

18 Years

Maximum Eligible Age

80 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No