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

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

Status
Completed
Phases
NA
Study type
Interventional
Source
ClinicalTrials.gov
Registry ID
NCT06820853
Enrollment
80
Registered
2025-02-11
Start date
2025-02-16
Completion date
2025-05-19
Last updated
2025-05-22

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Brachial Plexus Blockade

Brief summary

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

Detailed description

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

Interventions

DEVICEDiaphragmatic excursion evaluation

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

Sponsors

Cairo University
Lead SponsorOTHER

Study design

Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
PREVENTION
Masking
QUADRUPLE (Subject, Caregiver, Investigator, Outcomes Assessor)

Intervention model description

patients will be randomly allocated into 2 groups : single shot group and slow infusion group

Eligibility

Sex/Gender
ALL
Age
18 Years to 65 Years
Healthy volunteers
No

Inclusion criteria

* ASA I or II undergoing shoulder surgery under GA

Exclusion criteria

\-

Design outcomes

Primary

MeasureTime frameDescription
Complete phrenic nerve block defined as > 75% reduction in diaphragmatic excursionbaseline and 30 minutes after the blockdefined as \> 75% reduction in diaphragmatic excursion

Secondary

MeasureTime frameDescription
partial phrenic blockbaseline and 30 minutes after the block25-50% reduction in DE

Countries

Egypt

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Feb 4, 2026