Comparison of the Interscalene Block Alone Versus Combined With Superior Truncus Block During Shoulder Surgery in Diaphragmatic Function

NCT07338630 | Not Yet Recruiting

• 1 other identifier: Soh-Med--25-11-5MD
• Study Type: interventional
• Target: 60
• Locations: 0 countries
• Sites: N/A

Brief Summary

Primarily, This study aims to compare between interscalene block alone versus combined with superior truncus block in producing diaphragmatic paralysis and Secondarily aims to evaluate

1. 1.Effect on the pulmonary function.
2. 2.Duration of the sensory and motor block.
3. 3.Postoperative analgesic consumption.
4. 4.Any complications or side effects during shoulder surgery.

Conditions

Diaphragm Issues

Outcome Measures

Primary Outcomes (1)

• Comparison between interscalene block alone versus combined with superior truncus block inproducing diaphragmatic paralysis

  Assessment of diaphragmatic function by diaphragm excursion (DE) and diaphragm thickening fraction (TF) will be measured both before and 30 minutes post-block. To measure DE, patients will be placed in a supine position, a convex transducer (3.5 \~ 5 MHz) will be used to scan while the right diaphragm through the hepatic window and the left diaphragm through the splenic window, which located near the anterior-axillary line. The craniocaudal movement of the diaphragm will be documented during deep inspiration using M-mode. * Complete diaphragmatic paralysis was defined as a 75% \~ 100% reduction in DE, including the occurrence of paradoxical movement. * Partial diaphragmatic paralysis was defined as a 25% \~ 75% reduction in DE. * No diaphragmatic paralysis was indicated by a DE reduction of less than 25%. To measure TF, patients will be placed in the same position with the head of the bed at 45°degree

  Assessment of diaphragmatic function by diaphragm excursion (DE) and diaphragm thickening fraction (TF) will be measured both before and 30 minutes post-block.

Secondary Outcomes (4)

• Evaluation of the interscalene block alone versus combined with superior truncus block during shoulder surgery on the pulmonary function

  Assessment of pulmonary function by a handheld spirometer to measure forced vital capacity (FVC), forced expiratory volume ( FEV1, FEV2) with patients in an upright-seated position pre-block and 30 minutes post-block as well as 2-hours post-surgery

• Duration of the sensory and motor block onset, duration of the interscalene block alone versus combined with superior truncus block during shoulder surgery

  Sensory, motor block onset time every minute. Sensory, Motor block duration every hour in 1st 6 hours , every 2 hours in 2nd 6 hours

• Evaluation of postoperative analgesic consumption

  12 hours

• Evaluation of any complications or side effects during shoulder surgery

  24 hours

Study Arms (2)

Interscalene block alone

ACTIVE COMPARATOR

Interscalene block alone, we will inject 20 mL of 0.5 % bupivacaine plus 10 mL of 0.9 % normal saline around brachial plexus in the interscalene site under ultrasonograhy.

Other: Regional anesthesia in shoulder surgery

Interscalene block plus Superior truncus block

ACTIVE COMPARATOR

1. We will inject 7 mL of 0.5 % bupivacaine plus 3 mL of 0.9 % normal saline ( Total amount 10 ml) around brachial plexus in the interscalene site under ultrasonograhy. 2. Also we will inject 13 mL of 0.5 % bupivacaine plus 7 mL of 0.9 % normal saline ( Total amount 20 ml) around Superior trunk of brachial plexus under ultrasonagraphy.

Other: Regional anesthesia in shoulder surgery

Interventions

Regional anesthesia in shoulder surgery OTHER

Comparison of the interscalene block alone versus combined with superior truncus block during shoulder surgery in diaphragmatic function

Interscalene block alone; Interscalene block plus Superior truncus block

Eligibility Criteria

• Age: 20 Years - 65 Years
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• ASA (American Society of Anesthesiologists) I, II physical status.
• Aged between 20 and 65 years.
• Male or female.
• Body Mass index (BMI): 18-30 kg/m3.
• Scheduled for shoulder surgery.

You may not qualify if:

• Allergy to local anesthetics.
• Infection at the injection site.
• Coagulation disorders.
• Respiratory diseases ( Acute or Chronic) or Chest trauma.
• Multiple traumatized patients.
• Phrenic nerve injury
• Heart failure, Cardiomyopathy.
• Severe organ dysfunction
• Patient refusal

Sponsors & Collaborators

• Sohag University: lead

MeSH Terms

Interventions

Anesthesia, Conduction

Intervention Hierarchy (Ancestors)

Anesthesia; Anesthesia and Analgesia

Study Officials

• Sherif Salah Ismail Assistant lecturer of Anesthesia

  Assistant lecturer of Anesthesia and ICU and Pain Management of Sohag University hospitals

  PRINCIPAL INVESTIGATOR

Central Study Contacts

Sherif Salah Ismail Assistant lecturer of Anesthesia

CONTACT

01007272718; sherifsalah383@gmail.com

El hadad Ali Mosa Professor of Anesthesia

CONTACT

01019816967

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: TRIPLE
• Who Masked: PARTICIPANT, INVESTIGATOR, OUTCOMES ASSESSOR
• Purpose: DIAGNOSTIC
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Assistant lecturer of Anesthesia and ICU and Pain Management of Sohag University hospital

Model Details: The patients will be allocated to two groups : * Group I (30 patients) : Interscalene block alone, we will inject 20 mL of 0.5 % bupivacaine plus 10 mL of 0.9 % normal saline around brachial plexus in the interscalene site under ultrasonograhy. * Group S(30 patients): Interscalene block plus Superior truncus block 1. We will inject 7 mL of 0.5 % bupivacaine plus 3 mL of 0.9 % normal saline ( Total amount 10 ml) around brachial plexus in the interscalene site under ultrasonograhy. 2. Also we will inject 13 mL of 0.5 % bupivacaine plus 7 mL of 0.9 % normal saline ( Total amount 20 ml) around Superior trunk of brachial plexus under ultrasonagraphy.

Study Record Dates

• First Submitted: December 8, 2025
• First Posted: January 14, 2026
• Study Start: April 1, 2026
• Primary Completion (Estimated): April 1, 2027
• Study Completion (Estimated): June 1, 2027
• Last Updated: February 6, 2026

Record last verified: 2026-01