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

NCT06674551 | Not Yet Recruiting DMC

• 1 other identifier: FMASU MD128/2024
• Study Type: interventional
• Target: 60
• Locations: 0 countries
• Sites: N/A

Brief Summary

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.

Conditions

Interscalene Nerve Block; Suprascapular Nerve; Shoulder Surgery

Keywords

interscalene nerve block; axillary nerve block; shoulder surgery

Outcome Measures

Primary Outcomes (1)

• 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 Outcomes (1)

• postoperative pain using NRS

  24 hours postoperative

Study Arms (2)

Suprascapular nerve block and Axillary nerve block ( Group A)

EXPERIMENTAL

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

Interscalene nerve block (Group B)

EXPERIMENTAL

Patients will receive Interscalene nerve block (ISB) 30 minutes before the induction of general anaesthesia.

Procedure: Interscalene Nerve Block

Interventions

Suprascapular nerve block and Axillary nerve block PROCEDURE

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

Suprascapular nerve block and Axillary nerve block ( Group A)

Interscalene Nerve Block PROCEDURE

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.

Interscalene nerve block (Group B)

Eligibility Criteria

• Age: 18 Years - 60 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64)

You may qualify if:

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

You may not qualify if:

• 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.

Sponsors & Collaborators

• Ain Shams University: lead

Central Study Contacts

Mohamed Khaled Mahmoud, Master

CONTACT

+201211880428; midoabbas2019@gmail.com

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: SINGLE
• Who Masked: PARTICIPANT
• Purpose: PREVENTION
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: October 1, 2024
• First Posted: November 5, 2024
• Study Start: November 20, 2024
• Primary Completion: October 1, 2025
• Study Completion: November 1, 2025
• Last Updated: November 5, 2024

Record last verified: 2024-09