NCT07090733

Brief Summary

This study aims to evaluate the diaphragmatic movement and postoperative analgesia following anterior glenoid, suprascapular, and interscalene nerve blocks in patients undergoing elective arthroscopic shoulder surgery.

Trial Health

57
Monitor

Trial Health Score

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

Trial has exceeded expected completion date
Enrollment
80

participants targeted

Target at P50-P75 for not_applicable

Timeline
Completed

Started Jan 2025

Geographic Reach
1 country

1 active site

Status
recruiting

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

Trial Relationships

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Study Timeline

Key milestones and dates

Study Start

First participant enrolled

January 1, 2025

Completed
7 months until next milestone

First Submitted

Initial submission to the registry

July 21, 2025

Completed
8 days until next milestone

First Posted

Study publicly available on registry

July 29, 2025

Completed
5 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

December 31, 2025

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

December 31, 2025

Completed
Last Updated

July 29, 2025

Status Verified

July 1, 2025

Enrollment Period

12 months

First QC Date

July 21, 2025

Last Update Submit

July 21, 2025

Conditions

Outcome Measures

Primary Outcomes (1)

  • Incidence of hemi-diaphragmatic paralysis

    Incidence of hemi-diaphragmatic paralysis determined by ultrasound-guided assessment of diaphragmatic excursion. Diaphragmatic excursion will be measured before procedure (pre-block), 30 minutes after performing the block and post operative after complete recovery in post-anesthesia care unit (PACU).

    24 hours postoperatively

Secondary Outcomes (3)

  • Degree of pain

    24 hours postoperatively

  • Total analgesic consumption

    24 hours postoperatively

  • Degree of patient satisfaction

    24 hours postoperatively

Study Arms (4)

Group I

ACTIVE COMPARATOR

Patients will receive general anesthesia, plus an ultrasound-guided Interscalene brachial plexus block (ISB) with the injection of 15 mL of 0.25% bupivacaine. Patients will receive general anesthesia plus an ultrasound-guided suprascapular nerve block (SSNB)

Other: Interscalene brachial plexus block

Group II

EXPERIMENTAL

Patients will receive general anesthesia plus an ultrasound-guided suprascapular nerve block (SSNB) with injection of 15 ml of 0.25% bupivacaine.

Other: Suprascapular nerve block

Group III

EXPERIMENTAL

Patients will receive general anesthesia plus an ultrasound-guided anterior glenoid block with injection of 15 ml of 0.25% bupivacaine.

Other: Anterior glenoid block

Group IV

EXPERIMENTAL

Patients will receive general anesthesia, along with a total volume of 30 mL of bupivacaine 0.25%, divided into 15 mL of Bupivacaine 0.25% for ultrasound-guided SSNB and 15 mL of Bupivacaine 0.25% for ultrasound-guided anterior glenoid block.

Other: Suprascapular nerve block + Anterior glenoid block

Interventions

Patients will receive general anesthesia, plus an ultrasound-guided interscalene brachial plexus block (ISB) with the injection of 15 mL of 0.25% bupivacaine.

Also known as: 15 ml of 0.25% bupivacaine
Group I

Patients will receive general anesthesia plus an ultrasound-guided suprascapular nerve block (SSNB) with injection of 15 ml of 0.25% bupivacaine.

Also known as: 15 ml of 0.25% bupivacaine
Group II

Patients will receive general anesthesia plus an ultrasound-guided anterior glenoid block with injection of 15 ml of 0.25% bupivacaine.

Also known as: 15 ml of 0.25% bupivacaine
Group III

Patients will receive general anesthesia, along with a total volume of 30 mL of 0.25% bupivacaine, divided into 15 mL for ultrasound-guided SSNB and 15 mL for ultrasound-guided anterior glenoid block.

Also known as: 30 mL of 0.25% bupivacaine
Group IV

Eligibility Criteria

Age21 Years - 65 Years
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • Age from 21 to 65 years.
  • Both sexes.
  • American Society of Anesthesiologists (ASA) physical status I or II.
  • Scheduled for arthroscopic shoulder surgery.

You may not qualify if:

  • Patient's refusal to participate.
  • Patients with a history of allergy to local anesthetics.
  • Patients with a history of chronic use of painkillers.
  • Patients presented with mental dysfunction.
  • Patients with coagulation disorders.
  • Patients presented with skin or soft tissue infection at the proposed site of needle Insertion.
  • Pregnant Patients.
  • Patients with Chronic Obstructive Pulmonary Disease (COPD) or a Body Mass Index (BMI) of more than 40.

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Tanta University

Tanta, El-Gharbia, 31527, Egypt

RECRUITING

MeSH Terms

Conditions

Agnosia

Interventions

Bupivacaine

Condition Hierarchy (Ancestors)

Perceptual DisordersNeurobehavioral ManifestationsNeurologic ManifestationsNervous System DiseasesSigns and SymptomsPathological Conditions, Signs and Symptoms

Intervention Hierarchy (Ancestors)

AnilidesAmidesOrganic ChemicalsAniline CompoundsAmines

Central Study Contacts

Fatma E Elsamahy, Master

CONTACT

Study Design

Study Type
interventional
Phase
not applicable
Allocation
RANDOMIZED
Masking
DOUBLE
Who Masked
PARTICIPANT, OUTCOMES ASSESSOR
Purpose
TREATMENT
Intervention Model
PARALLEL
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
Assistant Lecturer of Anesthesiology, Surgical Intensive Care and Pain Medicine, Faculty of Medicine, Tanta University, Tanta, Egypt

Study Record Dates

First Submitted

July 21, 2025

First Posted

July 29, 2025

Study Start

January 1, 2025

Primary Completion

December 31, 2025

Study Completion

December 31, 2025

Last Updated

July 29, 2025

Record last verified: 2025-07

Data Sharing

IPD Sharing
Will share

The data will be available upon a reasonable request from the corresponding author after the end of study for one year.

Shared Documents
STUDY PROTOCOL
Time Frame
After the end of study for one year.
Access Criteria
The data will be available upon a reasonable request from the corresponding author.

Locations