Suprascapular and Axillary Versus Interscalene Blocks Regarding Phrenic Affection in Shoulder Surgeries

Comparative Study Between Combined Suprascapular and Axillary Nerve Blocks Versus Interscalene Nerve Block Regarding Phrenic Nerve Affection Assessed by Ultrasound Guided Diaphragmatic Excursion in Shoulder Arthroscopy Surgeries

This study is aims to compare between combined suprascapular and axillary nerve blocks versus interscalene nerve block regarding phrenic nerve affection assessed by ultrasound guided diaphragmatic excursion in shoulder arthroscopy surgeries.

Study Overview

• Status: Not yet recruiting
• Conditions: Shoulder Surgery; Interscalene Nerve Block; Suprascapular Nerve
• Intervention / Treatment: Procedure: Suprascapular nerve block and Axillary nerve block; Procedure: Interscalene Nerve Block

Detailed Description

Interscalene approach of brachial plexus nerve block is recognized as the gold standard technique for postoperative pain control after shoulder arthroscopy surgeries . However, it is associated with major adverse effects and possibly critical complications including phrenic nerve affection. Combined suprascapular and axillary nerve blocks are considered to be a safe and effective alternative to interscalene nerve block for shoulder surgery. Futher studies had been done regarding postoperative analgesia after shoulder arthroscopy surgeries using intersalene nerve block versus suprascapular and axillary nerve blocks.

In this study, we will Compare between combined suprascapular and axillary nerve blocks vs interscalene nerve block regarding objective phrenic nerve affection known as a serious complication of interscalene nerve block.

• Study Type: Interventional
• Enrollment (Estimated): 60
• Phase: Not Applicable

Contacts and Locations

• Study Contact: Name: Mohamed Khaled Mahmoud, Master; Phone Number: +201211880428; Email: midoabbas2019@gmail.com

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: Adult
• Accepts Healthy Volunteers: No

Description

Inclusion Criteria:

• Patients aged between 18 - 60 years old.
• Both sexes.
• ASA physical status classes I - II.
• Body mass index: 18-35 kg/ m2.

Exclusion Criteria:

• Infection at site of injection.
• Psychiatric illness.
• Central Nervous System Diseases like (epilepsy, stroke …etc.) or neurological disease affecting patient's upper limb.
• Dependence on opiates and psycho-dynamic medications.
• Moderate to severe pulmonary disease.
• Coagulopathy and bleeding disorders.
• Allergies to drug used (Bupivacaine 0.5%).
• Previous surgery at site of injection and history of radiotherapy.

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Prevention
• Allocation: Randomized
• Interventional Model: Parallel Assignment
• Masking: Single

Number of Arms

2

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Experimental: Suprascapular nerve block and Axillary nerve block ( Group A); Patients will receive Suprascapular nerve block (SSNB) and Axillary nerve block (AXNB) 30 minutes before the induction of general anaesthesia.	Procedure: Suprascapular nerve block and Axillary nerve block; A linear ultrasound probe will be placed in a sagittal plane at the superior medial border of the scapula. The probe will be moved laterally and then placed parallel to the scapular spine. when the needle tip contacts the bone just medial to the spinoglenoid notch and after confirmation of absence of vascular structure by color Doppler, 10 ml of 0.5% bupivacaine will be injected with aspiration every 3 ml to avoid intravascular injection and the spread of the local anaesthetic
Experimental: Interscalene nerve block (Group B); Patients will receive Interscalene nerve block (ISB) 30 minutes before the induction of general anaesthesia.	Procedure: Interscalene Nerve Block; The ultrasound probe will be placed in the supraclavicular fossa in a transverse orientation, aimed caudad into the thoracic cavity, to visualize the brachial plexus near the subclavian artery. Once identified, the plexus will be followed cephalad where it is found within the brachial plexus fascial sheath in the interscalene groove.

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
incidence of hemidiaphragmatic paralysis measured by ultrasound.	defined as a ≥ 25% reduction in diaphragmatic excursion measured by ultrasound.	measurement will be taken 8 hours after the performance of the block for fourth and last time.

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
postoperative pain using NRS	is to measure first rescue analgesia postoperative (24 hours)	24 hours postoperative

Collaborators and Investigators

• Sponsor: Ain Shams University

Study record dates

Study Major Dates

• Study Start (Estimated): November 20, 2024
• Primary Completion (Estimated): October 1, 2025
• Study Completion (Estimated): November 1, 2025

Study Registration Dates

• First Submitted: October 1, 2024
• First Submitted That Met QC Criteria: November 4, 2024
• First Posted (Estimated): November 5, 2024

Study Record Updates

• Last Update Posted (Estimated): November 5, 2024
• Last Update Submitted That Met QC Criteria: November 4, 2024
• Last Verified: September 1, 2024

More Information

Terms related to this study

• Keywords: axillary nerve block; shoulder surgery; interscalene nerve block
• Other Study ID Numbers: FMASU MD128/2024

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No
• product manufactured in and exported from the U.S.: No