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

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

Study Overview

• Status: Completed
• Conditions: Brachial Plexus Blockade
• Intervention / Treatment: Device: Diaphragmatic excursion evaluation

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

• Study Type: Interventional
• Enrollment (Actual): 80
• Phase: Not Applicable

Contacts and Locations

Study Locations

• Egypt
  • Giza Governorate
    • Cairo, Giza Governorate, Egypt, 6890
      • Cairo university

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: Adult; Older Adult
• Accepts Healthy Volunteers: No

Description

Inclusion Criteria:

• ASA I or II undergoing shoulder surgery under GA

Exclusion Criteria:

-

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Prevention
• Allocation: Randomized
• Interventional Model: Parallel Assignment
• Masking: Quadruple

Number of Arms

2

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Active Comparator: Single shot; They will receive a 10 ml of 0.5 % bupivacaine as a single shot	Device: Diaphragmatic excursion evaluation; They will receive 10 ml of 0.5% bupivacaine over 10 minutes
Active Comparator: Slow administration group; They will receive 10 ml of 0.5% bupivacaine over 10 minutes	Device: Diaphragmatic excursion evaluation; They will receive 10 ml of 0.5% bupivacaine over 10 minutes

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Complete phrenic nerve block defined as > 75% reduction in diaphragmatic excursion	defined as > 75% reduction in diaphragmatic excursion	baseline and 30 minutes after the block

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
partial phrenic block	25-50% reduction in DE	baseline and 30 minutes after the block

Collaborators and Investigators

• Sponsor: Cairo University

Publications and helpful links

General Publications

• 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.
• 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.
• 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.
• 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.
• 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.
• 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.

Study record dates

Study Major Dates

• Study Start (Actual): February 16, 2025
• Primary Completion (Actual): May 19, 2025
• Study Completion (Actual): May 19, 2025

Study Registration Dates

• First Submitted: February 6, 2025
• First Submitted That Met QC Criteria: February 10, 2025
• First Posted (Actual): February 11, 2025

Study Record Updates

• Last Update Posted (Actual): May 22, 2025
• Last Update Submitted That Met QC Criteria: May 19, 2025
• Last Verified: February 1, 2025

More Information

Terms related to this study

• Other Study ID Numbers: interscalane block and DE

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: UNDECIDED
• IPD Plan Description: Data will be available from corresponding author upon reasonable request

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No
• product manufactured in and exported from the U.S.: No