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

NCT ID: NCT06820853

Last Updated: 2025-05-22

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

COMPLETED

Clinical Phase

NA

Total Enrollment

80 participants

Study Classification

INTERVENTIONAL

Study Start Date

2025-02-16

Study Completion Date

2025-05-19

Brief Summary

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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

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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

Conditions

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Brachial Plexus Blockade

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

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

PREVENTION

Blinding Strategy

QUADRUPLE

Participants Caregivers Investigators Outcome Assessors

Study Groups

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Single shot

They will receive a 10 ml of 0.5 % bupivacaine as a single shot

Group Type ACTIVE_COMPARATOR

Diaphragmatic excursion evaluation

Intervention Type DEVICE

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

Slow administration group

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

Group Type ACTIVE_COMPARATOR

Diaphragmatic excursion evaluation

Intervention Type DEVICE

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

Interventions

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Diaphragmatic excursion evaluation

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

Intervention Type DEVICE

Eligibility Criteria

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Inclusion Criteria

* ASA I or II undergoing shoulder surgery under GA

Exclusion Criteria

\-
Minimum Eligible Age

18 Years

Maximum Eligible Age

65 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No

Sponsors

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Cairo University

OTHER

Sponsor Role lead

Responsible Party

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Mina Adolf Helmy

Lecturer of anesthesia, Cairo university

Responsibility Role PRINCIPAL_INVESTIGATOR

Locations

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Cairo University

Cairo, Giza Governorate, Egypt

Site Status

Countries

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Egypt

References

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Renes SH, Rettig HC, Gielen MJ, Wilder-Smith OH, van Geffen GJ. Ultrasound-guided low-dose interscalene brachial plexus block reduces the incidence of hemidiaphragmatic paresis. Reg Anesth Pain Med. 2009 Sep-Oct;34(5):498-502. doi: 10.1097/AAP.0b013e3181b49256.

Reference Type BACKGROUND
PMID: 19920426 (View on PubMed)

Wong AK, Keeney LG, Chen L, Williams R, Liu J, Elkassabany NM. Effect of Local Anesthetic Concentration (0.2% vs 0.1% Ropivacaine) on Pulmonary Function, and Analgesia After Ultrasound-Guided Interscalene Brachial Plexus Block: A Randomized Controlled Study. Pain Med. 2016 Dec;17(12):2397-2403. doi: 10.1093/pm/pnw057. Epub 2016 Apr 13.

Reference Type BACKGROUND
PMID: 28025374 (View on PubMed)

Fujimura N, Namba H, Tsunoda K, Kawamata T, Taki K, Igarasi M, Namiki A. Effect of hemidiaphragmatic paresis caused by interscalene brachial plexus block on breathing pattern, chest wall mechanics, and arterial blood gases. Anesth Analg. 1995 Nov;81(5):962-6. doi: 10.1097/00000539-199511000-00012.

Reference Type BACKGROUND
PMID: 7486085 (View on PubMed)

Verelst P, van Zundert A. Incidence of phrenic nerve block after interscalene brachial plexus block. Reg Anesth Pain Med. 2011 Jul-Aug;36(4):411-2; author reply 412. doi: 10.1097/AAP.0b013e318219e19d. No abstract available.

Reference Type BACKGROUND
PMID: 21697691 (View on PubMed)

Mitchell C, Adebajo A, Hay E, Carr A. Shoulder pain: diagnosis and management in primary care. BMJ. 2005 Nov 12;331(7525):1124-8. doi: 10.1136/bmj.331.7525.1124. No abstract available.

Reference Type BACKGROUND
PMID: 16282408 (View on PubMed)

Urwin M, Symmons D, Allison T, Brammah T, Busby H, Roxby M, Simmons A, Williams G. Estimating the burden of musculoskeletal disorders in the community: the comparative prevalence of symptoms at different anatomical sites, and the relation to social deprivation. Ann Rheum Dis. 1998 Nov;57(11):649-55. doi: 10.1136/ard.57.11.649.

Reference Type BACKGROUND
PMID: 9924205 (View on PubMed)

Other Identifiers

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interscalane block and DE

Identifier Type: -

Identifier Source: org_study_id

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