Intravenous Versus Perineural Effect Dexamethasone in Interscalene Nerve Block With Levobupivacaine
NCT ID: NCT04284007
Last Updated: 2020-02-25
Study Results
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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UNKNOWN
NA
90 participants
INTERVENTIONAL
2019-12-02
2020-12-31
Brief Summary
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The investigators compared the effect of perineural versus intravenous dexamethasone on the prolongation of the action of levobupivacaine in ultrasound guided interscalene block for shoulder and upper arm surgeries.
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Detailed Description
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The investigators compared the effect of perineural versus intravenous dexamethasone on the prolongation of the action of levobupivacaine in ultrasound guided interscalene block for shoulder and upper arm surgeries.
The study hypothesized that adding perineural dexamethasone to levobupivacaine in ultrasound guided interscalene block may be more superior to adding intravenous dexamethasone to levobupivacaine and levobupivacaine alone in shoulder and upper arm surgeries as regard analgesic effect, duration of analgesia and hemodynamic stability.
Conditions
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Study Design
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RANDOMIZED
PARALLEL
OTHER
DOUBLE
Study Groups
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Perineural levobupivacaine with intravenous saline
Patients will receive levobupivacaine plus saline in interscalene brachial plexus block in addition to intravenous saline.
Perineural levobupivacaine
Patients will receive 20 ml of 0.25% levobupivacaine plus 2ml saline in interscalene brachial plexus block plus 10 ml intravenous saline.
Perineural dexamethasone in addition to levobupivacaine
Patients will receive levobupivacaine-dexamethasone in interscalene brachial plexus block plus intravenous saline.
Perineural dexamethasone in addition to levobupivacaine
Patients will receive 20 ml of 0.25% levobupivacaine plus 4mg dexamethasone diluted in 2 ml saline in interscalene brachial plexus block plus 10 ml intravenous saline.
Intravenous dexamethasone with perineural levobupivacaine
Patients will receive levobupivacaine plus saline in interscalene brachial plexus block in addition to intravenous dexamethasone.
Intravenous dexamethasone with perineural levobupivacaine
Patients will receive 20 ml of 0.25% levobupivacaine plus 2ml saline in interscalene brachial plexus block plus 4 mg intravenous dexamethasone diluted in 10 ml saline.
Interventions
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Perineural levobupivacaine
Patients will receive 20 ml of 0.25% levobupivacaine plus 2ml saline in interscalene brachial plexus block plus 10 ml intravenous saline.
Perineural dexamethasone in addition to levobupivacaine
Patients will receive 20 ml of 0.25% levobupivacaine plus 4mg dexamethasone diluted in 2 ml saline in interscalene brachial plexus block plus 10 ml intravenous saline.
Intravenous dexamethasone with perineural levobupivacaine
Patients will receive 20 ml of 0.25% levobupivacaine plus 2ml saline in interscalene brachial plexus block plus 4 mg intravenous dexamethasone diluted in 10 ml saline.
Eligibility Criteria
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Inclusion Criteria
Exclusion Criteria
* Neuromuscular diseases (as myopathies, myasthenia gravies, …...)
* Hematological diseases, bleeding or coagulation abnormality.
* Psychiatric diseases.
* Local skin infection
* Sepsis at site of the block.
* Known intolerance to the study drugs.
* Body Mass Index \> 40 Kg/m2
* contralateral phrenic palsy
* pneumothorax
* pneumectomy
* severe COPD
20 Years
60 Years
ALL
No
Sponsors
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Mansoura University
OTHER
Responsible Party
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Principal Investigators
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Nahla S El-Ebahnsawy, MD
Role: STUDY_CHAIR
Professor of Anesthesia and Surgical Intensive Care
Hazem E Moawed, MD
Role: STUDY_DIRECTOR
Assistant Professor of Anesthesia and Surgical Intensive Care
Locations
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Mansoura University
Al Mansurah, Dakhlia, Egypt
Countries
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Other Identifiers
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MFM_IRB, MS.18.03.65 -
Identifier Type: -
Identifier Source: org_study_id
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