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

NCT06820853 | Completed

• 1 other identifier: interscalane block and DE
• Study Type: interventional
• Target: 80
• Locations: 1 country
• Sites: 1

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

Conditions

Brachial Plexus Blockade

Outcome Measures

Primary Outcomes (1)

• 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 Outcomes (1)

• partial phrenic block

  baseline and 30 minutes after the block

Study Arms (2)

Single shot

ACTIVE COMPARATOR

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

Device: Diaphragmatic excursion evaluation

Slow administration group

ACTIVE COMPARATOR

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

Device: Diaphragmatic excursion evaluation

Interventions

Diaphragmatic excursion evaluation DEVICE

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

Single shot; Slow administration group

Eligibility Criteria

• Age: 18 Years - 65 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• ASA I or II undergoing shoulder surgery under GA

Sponsors & Collaborators

• Cairo University: lead

Study Sites (1)

Cairo University

Cairo, Giza Governorate, 6890, Egypt

Location

Related Publications (7)

• 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.

  PMID: 19920426 BACKGROUND

• 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.

  PMID: 28025374 BACKGROUND

• 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.

  PMID: 7486085 BACKGROUND

• 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.

  PMID: 21697691 BACKGROUND

• 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.

  PMID: 16282408 BACKGROUND

• 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.

  PMID: 9924205 BACKGROUND

• Helmy MA, Gamal B, Milad LM, Adawy AE, Ibrahium F, Kasem S, Mustafa H. Single-shot versus slow infusion interscalene block and its impact on diaphragmatic function in patients undergoing shoulder surgery, a double blind randomized controlled trial. Anaesth Crit Care Pain Med. 2025 Nov 7:101668. doi: 10.1016/j.accpm.2025.101668. Online ahead of print.

  PMID: 41207378 DERIVED

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: QUADRUPLE
• Who Masked: PARTICIPANT, CARE PROVIDER, INVESTIGATOR, OUTCOMES ASSESSOR
• Purpose: PREVENTION
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Lecturer of anesthesia, Cairo university

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

Study Record Dates

• First Submitted: February 6, 2025
• First Posted: February 11, 2025
• Study Start: February 16, 2025
• Primary Completion: May 19, 2025
• Study Completion: May 19, 2025
• Last Updated: May 22, 2025

Record last verified: 2025-02

Locations

EG (1)