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NCT Number: NCT06674551

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

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Key information

Conditions

Interscalene Nerve Block Shoulder Surgery Suprascapular Nerve

Age range

18 year–60 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

About this study

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.

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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.

Treatment and study plan

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

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.

Primary outcomes

  1. incidence of hemidiaphragmatic paralysis measured by ultrasound.

    Time frame: measurement will be taken 8 hours after the performance of the block for fourth and last time.

    defined as a ≥ 25% reduction in diaphragmatic excursion measured by ultrasound.

Secondary outcomes

  1. postoperative pain using NRS

    Time frame: 24 hours postoperative

    is to measure first rescue analgesia postoperative (24 hours)

Study contacts

Contact information is provided by the study sponsor or research team.

Mohamed Khaled Mahmoud, Master

CONTACT

[email protected]

+201211880428

Sponsors and collaborators

Lead sponsor

Ain Shams University

Other

Registry information

Official study title

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

Important dates

Study start
2024
Primary completion
2025
Study completion
2025
First posted
Nov 5, 2024
Registry last updated
Nov 5, 2024

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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