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Completed

NCT Number: NCT06820853

Single-shot Versus Slow Infusion Interscalene Block and Its Impact on Diaphragmatic Function in Patients Undergoing Shoulder Surgery.

Interscalene brachial plexus block is a commonly chosen anesthetic technique for shoulder and proximal arm surgery yet it carry several risks including phrenic nerve block.

Researchers assumed that slow administration of local anesthetic would reduce incidence of phrenic nerve block

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Key information

Conditions

Brachial Plexus Blockade

Age range

18 year–65 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

Cairo University

Cairo, Giza Governorate, 6890, Egypt

About this study

patients will be randomly allocated into one of 2 groups ( single shot group) and slow administration group . single shot will receive a 10 ml bolus of 0.5% bupivacaine the other group will receive 10 ml 0.5 % bupivacaine over 10 minutes (at a rate of 1ml/minute) using syringe pump An experienced operator who will be blinded to method of administration will conducted diaphragmatic excursion of ipsilateral hemidiaphragm using curved probe at baseline and at 10 minutes interval for 30 minutes Complete phrenic will be defined as 75% or more reduction in DE, while partial failure as 25%-50% reduction in DE

Who can participate

Healthy volunteers accepted: No

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

Inclusion criteria

  • ASA I or II undergoing shoulder surgery under GA

Exclusion criteria

-

Treatment and study plan

Diaphragmatic excursion evaluation

Device

They will receive 10 ml of 0.5% bupivacaine over 10 minutes

Primary outcomes

  1. Complete phrenic nerve block defined as > 75% reduction in diaphragmatic excursion

    Time frame: baseline and 30 minutes after the block

    defined as > 75% reduction in diaphragmatic excursion

Secondary outcomes

  1. partial phrenic block

    Time frame: baseline and 30 minutes after the block

    25-50% reduction in DE

Sponsors and collaborators

Lead sponsor

Cairo University

Other

Registry information

Official study title

Single-shot Versus Slow Infusion Interscalene Block and Its Impact on Diaphragmatic Function in Patients Undergoing Shoulder Surgery, a Randomized Controlled Trial

Important dates

Study start
2025
Primary completion
2025
Study completion
2025
First posted
Feb 11, 2025
Registry last updated
May 22, 2025

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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