Ultrasound-Guided Extrafascial Versus Intrafascial Interscalene Brachial Plexus Block in Shoulder Arthroscopy

NCT ID: NCT05222334

Last Updated: 2022-02-03

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

50 participants

Study Classification

INTERVENTIONAL

Study Start Date

2022-02-01

Study Completion Date

2023-02-01

Brief Summary

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The aim of the study is to compare the diaphragmatic excursion and postoperative analgesia in the extrafascial versus intrafascial Interscalene brachial plexus block in patients undergoing shoulder arthroscopy.

Detailed Description

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Conditions

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Arthroscopy Analgesia Intrafascial Interscalene Brachial Plexus Block

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

Primary Study Purpose

TREATMENT

Blinding Strategy

DOUBLE

Participants Outcome Assessors

Study Groups

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Intrafascial interscalene brachial plexus block group

The patients will receive 10 ml of 0.5% bupivacaine for intrafascial interscalene brachial plexus block group

Group Type EXPERIMENTAL

Intrafascial interscalene brachial plexus block

Intervention Type PROCEDURE

After sterilization of skin with povidone-iodine (betadine) and skin infiltration with 1-3ml lidocaine 1%, interscalene brachial plexus block will be performed using an ultrasound machine (Phillips Cx-50,Amsterdam, Netherlands) with a linear probe (L12-3 MHz) will be used in both groups. The US transducer will be placed under aseptic fashion on the lateral side of the neck at the cricoid cartilage level to view three hypoechoic structures, that represent the roots of the brachial plexus.

The two outermost nerve roots (C5 and C6) between the anterior and the middle scalene muscles will be identified and the local anesthetic (10 ml 0.5% bupivacaine) is then injected, so that spread will be seen immediately between the C5 and the C6 nerve roots.

Bupivacaine

Intervention Type DRUG

bupivacaine

Extrafascial interscalene brachial plexus block group

The patients will receive 10 ml of 0.5% bupivacaine for extrafascial interscalene brachial plexus block group

Group Type EXPERIMENTAL

Extrafascial interscalene brachial plexus block group

Intervention Type PROCEDURE

Final needle tip position will be 4 mm lateral to the brachial plexus sheath, at a level equidistant between C5 and C6 roots. The distance of 4 mm is chosen according to the calculated success rate over 90% reported. the local anesthetic (10 ml 0.5% bupivacaine) is then injected

Bupivacaine

Intervention Type DRUG

bupivacaine

Interventions

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Intrafascial interscalene brachial plexus block

After sterilization of skin with povidone-iodine (betadine) and skin infiltration with 1-3ml lidocaine 1%, interscalene brachial plexus block will be performed using an ultrasound machine (Phillips Cx-50,Amsterdam, Netherlands) with a linear probe (L12-3 MHz) will be used in both groups. The US transducer will be placed under aseptic fashion on the lateral side of the neck at the cricoid cartilage level to view three hypoechoic structures, that represent the roots of the brachial plexus.

The two outermost nerve roots (C5 and C6) between the anterior and the middle scalene muscles will be identified and the local anesthetic (10 ml 0.5% bupivacaine) is then injected, so that spread will be seen immediately between the C5 and the C6 nerve roots.

Intervention Type PROCEDURE

Extrafascial interscalene brachial plexus block group

Final needle tip position will be 4 mm lateral to the brachial plexus sheath, at a level equidistant between C5 and C6 roots. The distance of 4 mm is chosen according to the calculated success rate over 90% reported. the local anesthetic (10 ml 0.5% bupivacaine) is then injected

Intervention Type PROCEDURE

Bupivacaine

bupivacaine

Intervention Type DRUG

Eligibility Criteria

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Inclusion Criteria

* Adult patients of both sexes aged (21-60years) with American Society of Anesthesiologists (ASA) physical status I/II scheduled for shoulder arthroscopy

Exclusion Criteria

1. Patient refusal.
2. Pre-existing (obstructive or restrictive) pulmonary disease.
3. Bleeding disorders (coagulopathy).
4. Mental dysfunction.
5. History of allergy to local anesthetics.
6. Pregnancy
7. Body mass index (BMI) \>40
Minimum Eligible Age

21 Years

Maximum Eligible Age

60 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No

Sponsors

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Tanta University

OTHER

Sponsor Role lead

Responsible Party

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Radwa Emad Eissa

Assistant lecturer

Responsibility Role PRINCIPAL_INVESTIGATOR

Other Identifiers

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33802/4/20

Identifier Type: -

Identifier Source: org_study_id

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