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Comparison of an Interscalene Nerve Block With or Without Stellate Ganglion Block for Shoulder Surgery

NCT ID: NCT02879916

Last Updated: 2016-10-27

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

30 participants

Study Classification

INTERVENTIONAL

Study Start Date

2011-10-31

Study Completion Date

2016-09-30

Brief Summary

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This study describes the difference of analgesic effect of levobupivacaine 0.5% administered through an interscalene nerve block with or without a stellate ganglion block. The length of the analgesic effect is our primary outcome parameter. Half of the recruited patients will receive a stellate ganglion block and half of the patients won't.

Detailed Description

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Conditions

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Anesthesia, Regional

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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Placebo

NaCl 0.9% 3ml perineural stellate ganglion injection

Group Type PLACEBO_COMPARATOR

NaCl 0.9%

Intervention Type DRUG

Inject 3ml of NaCl 0.9% into the stellate ganglion area

Stellate ganglion block

Levobupivacaine 3ml perineural stellate ganglion injection

Group Type ACTIVE_COMPARATOR

Levobupivacaine

Intervention Type DRUG

Inject 3ml of levobupavacaine into the stellate ganglion area

Interventions

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Levobupivacaine

Inject 3ml of levobupavacaine into the stellate ganglion area

Intervention Type DRUG

NaCl 0.9%

Inject 3ml of NaCl 0.9% into the stellate ganglion area

Intervention Type DRUG

Eligibility Criteria

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Inclusion Criteria

* ASA class 1 to 3
* Need for shoulder surgery

Exclusion Criteria

* Mental retardation
* allergy for local anesthetics
* a medical reason as a contra-indication for NSAID use
* Diabetes mellitus
* peripheral neuropathy
* chronic analgetic use
* chronic pain patients
Minimum Eligible Age

18 Years

Maximum Eligible Age

75 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No

Sponsors

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University Hospital, Antwerp

OTHER

Sponsor Role lead

Responsible Party

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Tom Schepens, MD

research assistant

Responsibility Role PRINCIPAL_INVESTIGATOR

Principal Investigators

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Luc Sermeus, MD

Role: PRINCIPAL_INVESTIGATOR

Consultant

Other Identifiers

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B300201111454

Identifier Type: REGISTRY

Identifier Source: secondary_id

11/20/162

Identifier Type: -

Identifier Source: org_study_id