Intravenous Versus Perineural Effect Dexamethasone in Interscalene Nerve Block With Levobupivacaine

NCT ID: NCT04284007

Last Updated: 2020-02-25

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

90 participants

Study Classification

INTERVENTIONAL

Study Start Date

2019-12-02

Study Completion Date

2020-12-31

Brief Summary

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Interscalene brachial plexus block can be used as an additive to general anaesthesia or as the primary anaesthetic for shoulder surgeries for pain management.

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.

Detailed Description

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Dexamethasone had been shown to prolong the duration of postoperative analgesia when given as an adjuvant for peripheral nerve blocks.

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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Shoulder Pain

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

Primary Study Purpose

OTHER

Blinding Strategy

DOUBLE

Participants Caregivers
Double-blind

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.

Group Type ACTIVE_COMPARATOR

Perineural levobupivacaine

Intervention Type DRUG

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.

Group Type EXPERIMENTAL

Perineural dexamethasone in addition to levobupivacaine

Intervention Type DRUG

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.

Group Type EXPERIMENTAL

Intravenous dexamethasone with perineural levobupivacaine

Intervention Type DRUG

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.

Intervention Type DRUG

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.

Intervention Type DRUG

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.

Intervention Type DRUG

Eligibility Criteria

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Inclusion Criteria

* American Society of Anesthesiologists physical status grade I and grade II.

Exclusion Criteria

* Patient refusal.
* 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
Minimum Eligible Age

20 Years

Maximum Eligible Age

60 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No

Sponsors

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Mansoura University

OTHER

Sponsor Role lead

Responsible Party

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Responsibility Role SPONSOR

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

Site Status

Countries

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Egypt

Other Identifiers

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MFM_IRB, MS.18.03.65 -

Identifier Type: -

Identifier Source: org_study_id

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