Sparing Diaphragm; ISO Block Versus Low Volume Scalene Block

NCT ID: NCT03331237

Last Updated: 2017-11-06

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

72 participants

Study Classification

INTERVENTIONAL

Study Start Date

2017-10-09

Study Completion Date

2018-04-30

Brief Summary

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For shoulder analgesia, both ISO block and low volume scalene (LVS) block (using 5 ml of local anesthetics) are suggested to have a low incidence of hemi-diaphragmatic pariesis (HDP).

The aim of this study was to compare the incidence of HDP and the analgesic efficacy of the LVS block versus ISO block.

Detailed Description

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Conditions

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Shoulder Arthropathy Associated With Other Conditions

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

Primary Study Purpose

PREVENTION

Blinding Strategy

QUADRUPLE

Participants Caregivers Investigators Outcome Assessors

Study Groups

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LVS group

interscalene injection

Group Type ACTIVE_COMPARATOR

scalene block

Intervention Type PROCEDURE

scalene block using 5ml of ropivacaine

ISO group

in this group all patients will receive ISO block.

Group Type ACTIVE_COMPARATOR

ISO block

Intervention Type PROCEDURE

ISO block is a combined block of suprascapular nerve and brachial plexus cords using a single puncture

Interventions

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scalene block

scalene block using 5ml of ropivacaine

Intervention Type PROCEDURE

ISO block

ISO block is a combined block of suprascapular nerve and brachial plexus cords using a single puncture

Intervention Type PROCEDURE

Eligibility Criteria

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Inclusion Criteria

* patients who were scheduled for arthroscopic shoulder surgery

Exclusion Criteria

* aged \<18y
* BMI \>35,
* ASA greater \>III,
* an infection at the injection site
* has a contraindication for laryngeal mask or the medications used in this study.
Minimum Eligible Age

18 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No

Sponsors

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Healthpoint Hospital

OTHER

Sponsor Role lead

Responsible Party

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Ahmad Muhammad Taha

Consultant of aneathesia

Responsibility Role PRINCIPAL_INVESTIGATOR

Locations

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Healthpoint Hospital

Abu Dhabi, , United Arab Emirates

Site Status RECRUITING

Countries

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United Arab Emirates

Central Contacts

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Sabah Zahooruddin

Role: CONTACT

Phone: 009712 4929000

Email: [email protected]

Facility Contacts

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Sabah Zahooruddin

Role: primary

References

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Taha AM, Yurdi NA, Elahl MI, Abd-Elmaksoud AM. Diaphragm-sparing effect of the infraclavicular subomohyoid block vs low volume interscalene block. A randomized blinded study. Acta Anaesthesiol Scand. 2019 May;63(5):653-658. doi: 10.1111/aas.13322. Epub 2019 Jan 30.

Reference Type DERIVED
PMID: 30697688 (View on PubMed)

Other Identifiers

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REC007

Identifier Type: -

Identifier Source: org_study_id