NCT06396455

Brief Summary

Diaphragmatic dysfunction can be detected as a decrease in forced vital capacity (FVC) and forced expiratory volume at 1 s (FEV1) on spirometry or as lower diaphragmatic excursion (DE) on US, the latter having become the gold standard in thoracic assessment.

Trial Health

87
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
60

participants targeted

Target at P25-P50 for not_applicable

Timeline
Completed

Started Jan 2023

Geographic Reach
1 country

1 active site

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Start

First participant enrolled

January 26, 2023

Completed
1.2 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

March 28, 2024

Completed
7 days until next milestone

Study Completion

Last participant's last visit for all outcomes

April 4, 2024

Completed
20 days until next milestone

First Submitted

Initial submission to the registry

April 24, 2024

Completed
8 days until next milestone

First Posted

Study publicly available on registry

May 2, 2024

Completed
Last Updated

May 2, 2024

Status Verified

April 1, 2024

Enrollment Period

1.2 years

First QC Date

April 24, 2024

Last Update Submit

May 1, 2024

Conditions

Keywords

Anterior Suprascapular Nerve BlockSuprascapular Nerve Block

Outcome Measures

Primary Outcomes (1)

  • visual analogue score

    The visual analogue score (VAS) was used (0 indicating no pain and 10 indicating worst unbearable pain) at rest and upon flexion for assessment of pain intensity upon arrival to the PACU

    Postoperative pain was assessed using VAS at Postoperative care unit, 2 hours, 4 hours, 6 hours, 8 hours, 12 hours, and 24hours after block administration postoperatively

Secondary Outcomes (1)

  • Patient satisfaction

    24 hours postoperatively

Study Arms (2)

interscalene block group

EXPERIMENTAL

patients received an ultrasound guided interscalene approach of brachial plexus plane block

Procedure: interscalene block group

suprascapular nerve block group

EXPERIMENTAL

patients received ultrasound guided suprascapular nerve block.

Procedure: Suprascapular nerve block group

Interventions

The ISB group scanning was done by linear ultrasound probe just below the level of the cricoid cartilage medial to the sternocleidomastoid muscle; the skin was disinfected, and the transducer was positioned in the transverse plane to identify the carotid artery. Once the artery was identified, the transducer was moved slightly laterally across the neck to identify the scalene muscles and the brachial plexus that is present between the anterior and middle scalene muscles. 3 ml lidocaine 1% was injected at puncture site The needle was then inserted in-plane toward the brachial plexus, in a lateral-to-medial direction. After a careful aspiration, 20 ml of bupivacaine 0.25% was injected.

Also known as: Group ISB
interscalene block group

After cleaning the skin with an antiseptic solution, an ultrasound probe was put in sagittal orientation at the superior medial border of the scapula to identify the pleura and then moved laterally; when it was parallel to the spine of the scapula, the transducer was moved cephalad and the suprascapular fossa was identified, and then the transducer was moved lateral to locate the suprascapular notch. The suprascapular nerve was a round hyperechoic structure beneath the transverse scapular ligament in the scapular notch. 3 ml lidocaine 1% was injected at puncture site then the needle was inserted along the longitudinal axis of the ultrasound beam, and 10 ml of bupivacaine 0.25% was injected.

Also known as: group SSNB
suprascapular nerve block group

Eligibility Criteria

Age18 Years - 65 Years
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • aged (18-65 years)
  • American Society of Anesthesiologists (ASA) physical status I or II
  • scheduled for elective arthroscopic shoulder surgery

You may not qualify if:

  • pre-existing respiratory,
  • cardiac, renal, neurological, or hepatic disease, neuropathy affecting brachial plexus
  • contraindication to peripheral nerve block (e.g., coagulopathy),

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Benha University

Banhā, 13511, Egypt

Location

Study Officials

  • Ramy Saleh, MD

    Anesthesia and surgical ICU department, Faculty of Medicine, Benha University, Egypt

    PRINCIPAL INVESTIGATOR

Study Design

Study Type
interventional
Phase
not applicable
Allocation
RANDOMIZED
Masking
DOUBLE
Who Masked
PARTICIPANT, OUTCOMES ASSESSOR
Masking Details
The patients, outcome assessors were blinded to the group allocation,
Purpose
PREVENTION
Intervention Model
PARALLEL
Model Details: Group ISB (interscalene block group) received an ultrasound guided interscalene approach of brachial plexus plane block and group SSNB (suprascapular nerve block) received ultrasound guided suprascapular nerve block.
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
Professor

Study Record Dates

First Submitted

April 24, 2024

First Posted

May 2, 2024

Study Start

January 26, 2023

Primary Completion

March 28, 2024

Study Completion

April 4, 2024

Last Updated

May 2, 2024

Record last verified: 2024-04

Data Sharing

IPD Sharing
Will not share

Locations