Dexmedetomidine Versus Dexamethasone With Levobupivacaine in Interscalene Block

NCT ID: NCT03940469

Last Updated: 2019-05-07

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

60 participants

Study Classification

INTERVENTIONAL

Study Start Date

2016-07-03

Study Completion Date

2019-01-01

Brief Summary

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The investigators compared between dexamethasone and dexmedetomidine when added to levobupivacaine in the quality and duration of ultrasound-guided interscalene block during shoulder arthroscopy.

Detailed Description

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Sixty patients were enrolled and divided into three groups 20 each, Group C received 35ml levobupivacaine+2ml normal saline under ultrasound guided interscalene block. Group H received 35ml levobupivacaine+8mg dexamethasone under ultrasound guided interscalene block. Group D received 35ml levobupivacaine+100umg dexmedetomidine+1ml normal saline. The primary outcome was the postoperative pain which was assessed by Visual analog score(VAS), the secondary outcomes were the onset and duration of sensory and motor block, the total amount of analgesic requirement, and blood cortisol level.

Conditions

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Postoperative Analgesia Postoperative Complications

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

three groups 20 each, Group C received 35ml levobupivacaine+2ml normal saline under ultrasound guided interscalene block. Group H received 35ml levobupivacaine+8mg dexamethasone under ultrasound guided interscalene block. Group D received 35ml levobupivacaine+100umg dexmedetomidine+1ml normal saline.
Primary Study Purpose

TREATMENT

Blinding Strategy

DOUBLE

Participants Outcome Assessors
both the patients and the observer were blind to the treatment groups

Study Groups

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Control group

received 35ml levobupivacaine+2ml normal saline under ultrasound guided interscalene block.

Group Type PLACEBO_COMPARATOR

Saline

Intervention Type DRUG

2 ml normal saline

Dexamethasone group

received 35ml levobupivacaine+8mg dexamethasone

Group Type ACTIVE_COMPARATOR

Dexamethasone Injection

Intervention Type DRUG

8 mg dexamethasone

Dexmeteomidine group

received 35ml levobupivacaine+100umg dexmedetomidine+1ml normal saline.

Group Type ACTIVE_COMPARATOR

Dexmedetomidine Hydrochloride

Intervention Type DRUG

100 microgram dexmedetomidine

Interventions

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Saline

2 ml normal saline

Intervention Type DRUG

Dexamethasone Injection

8 mg dexamethasone

Intervention Type DRUG

Dexmedetomidine Hydrochloride

100 microgram dexmedetomidine

Intervention Type DRUG

Other Intervention Names

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normal saline dexamethsone dexmedetomidine

Eligibility Criteria

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Inclusion Criteria

* Sixty healthy patients ASA I-II
* Aged 18-60 years
* Of both sexes
* Scheduled for shoulder arthroscopy using ultrasound interscalene block were enrolled.

Exclusion Criteria

* Patients with a history of any allergic reactions to levobupivacaine, dexamethasone or α2 agonists
* All patients with hypertension, cardiac, hepatic, renal or pulmonary diseases, - Patients who were under treatment by α2 agonist or antagonists
* Pregnant women
* Psychiatric patients
* Patients with a previous history or clinical evidence of central or peripheral neurological disease
* Coagulopathy or anticoagulant/antiaggregant therapy
* Contralateral phrenic nerve paresis
* Patients who have an infection at the site of the block.
* Every patient who had an anatomical or vascular abnormality in the upper extremity were excluded from this study.
Minimum Eligible Age

18 Years

Maximum Eligible Age

60 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

Yes

Sponsors

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Mamdoh Elsayed Lotfy

UNKNOWN

Sponsor Role collaborator

Osama Abdallah Elsharkawy

UNKNOWN

Sponsor Role collaborator

Basma Abdelhamid Fathy

UNKNOWN

Sponsor Role collaborator

Menoufia University

OTHER

Sponsor Role lead

Responsible Party

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ashraf magdy eskandr

Assistant Professor of Anesthesia, ICU

Responsibility Role PRINCIPAL_INVESTIGATOR

Principal Investigators

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mamdouh e lotfy, m.d.

Role: STUDY_DIRECTOR

emeritus professor

Locations

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Ashraf Eskandr

Shibīn al Kawm, Monufia Governorate, Egypt

Site Status

Countries

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Egypt

Other Identifiers

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Interscalene Dexmedetomidine

Identifier Type: -

Identifier Source: org_study_id

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