NCT07640464

Brief Summary

This prospective observational study was conducted to evaluate the effects of a combined infraclavicular brachial plexus block and anterior suprascapular nerve block on diaphragmatic function in patients undergoing arthroscopic shoulder surgery. A total of 61 adult patients were enrolled in the study. Diaphragmatic excursion was assessed using ultrasonography both prior to block administration and 30 minutes following the procedure during normal and deep breathing. The primary objective was to assess changes in diaphragmatic excursion and determine the incidence of hemidiaphragmatic paralysis associated with this combined block technique. Secondary outcomes included block performance time, duration of postoperative analgesia, the need for additional intraoperative sedation or analgesia, the occurrence of adverse events, and levels of patient and surgeon satisfaction. The study sought to determine whether this regional anesthesia approach could provide effective anesthesia and analgesia while minimizing impairment of diaphragmatic function.

Trial Health

87
On Track

Trial Health Score

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

Enrollment
61

participants targeted

Target at P25-P50 for all trials

Timeline
Completed

Started Feb 2025

Shorter than P25 for all trials

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

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Study Timeline

Key milestones and dates

Study Start

First participant enrolled

February 22, 2025

Completed
5 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

July 20, 2025

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

July 20, 2025

Completed
11 months until next milestone

First Submitted

Initial submission to the registry

May 31, 2026

Completed
10 days until next milestone

First Posted

Study publicly available on registry

June 10, 2026

Completed
Last Updated

June 10, 2026

Status Verified

June 1, 2026

Enrollment Period

5 months

First QC Date

May 31, 2026

Last Update Submit

June 5, 2026

Conditions

Keywords

Anterior Suprascapular Nerve BlockInfraclavicular Brachial Plexus BlockDiaphragmatic ExcursionShoulder ArthroscopyRegional Anesthesia

Outcome Measures

Primary Outcomes (1)

  • Change in Diaphragmatic Excursion at 30 Minutes After Block Administration

    Diaphragmatic excursion measured by ultrasonography during normal and deep breathing before block administration and 30 minutes after block administration. The percentage change from baseline was calculated.

    30 minutes after block administration

Secondary Outcomes (6)

  • Incidence of Hemidiaphragmatic Paralysis

    30 minutes after block administration

  • Degree of Hemidiaphragmatic Paralysis

    30 minutes after block administration

  • Block Performance Time

    From needle insertion to completion of the block procedure

  • Additional Intraoperative Analgesia Requirement

    From surgical incision to the end of surgery

  • Time to First Analgesic Requirement

    Up to 24 hours after surgery

  • +1 more secondary outcomes

Study Arms (1)

Patients Undergoing Arthroscopic Shoulder Surgery

Patients undergoing arthroscopic shoulder surgery who received a combined infraclavicular brachial plexus block and anterior suprascapular nerve block. Diaphragmatic excursion was evaluated using ultrasonography before and after block administration.

Eligibility Criteria

Age18 Years - 80 Years
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)
Sampling MethodNon-Probability Sample
Study Population

Adult patients aged 18-80 years with ASA physical status I-III undergoing elective arthroscopic shoulder surgery at Gazi University Faculty of Medicine Hospital. Eligible participants received ultrasound-guided combined infraclavicular brachial plexus block and anterior suprascapular nerve block. The study evaluated changes in diaphragmatic excursion measured by ultrasonography before and after block administration.

You may qualify if:

  • Patients aged 18-80 years.
  • ASA physical status I-III.
  • Scheduled for elective arthroscopic shoulder surgery.
  • Ability to provide written informed consent

You may not qualify if:

  • Refusal to undergo peripheral nerve block.
  • Pre-existing peripheral neuropathy.
  • Known pulmonary, hepatic, or renal disease.
  • Allergy to local anesthetics.
  • Infection at the block site.
  • Pre-existing neurological deficit.
  • Body mass index (BMI) \> 40 kg/m².
  • Coagulopathy.
  • Sepsis.
  • Previous surgery at the planned block site.
  • Major psychiatric disorders.
  • Inability to complete diaphragmatic ultrasonographic assessment.

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Gazi University Faculty of Medicine Hospital

Ankara, Ankara, 06500, Turkey (Türkiye)

Location

Study Officials

  • IRFAN GUNGOR, MD

    Gazi university faculty of medicine

    PRINCIPAL INVESTIGATOR

Study Design

Study Type
observational
Observational Model
COHORT
Time Perspective
PROSPECTIVE
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
Anesthesiology Resident

Study Record Dates

First Submitted

May 31, 2026

First Posted

June 10, 2026

Study Start

February 22, 2025

Primary Completion

July 20, 2025

Study Completion

July 20, 2025

Last Updated

June 10, 2026

Record last verified: 2026-06

Data Sharing

IPD Sharing
Will not share

Individual participant data collected during the study will not be shared with other researchers because of institutional policies, ethical considerations, and protection of participant confidentiality.

Locations