NCT06146179

Brief Summary

The suprascapular nerve, originating from the C5 trunk, provides innervation to the acromioclavicular and glenohumeral joints. The supraclavicular nerve, a branch of the cervical plexus, contributes to the sensory innervation of the upper deltoid region. Cervical and brachial plexus blocks can cause diaphragm paralysis. This study examined the effects of low-volume combined anterior suprascapular nerve block and superficial cervical plexus block on pain and phrenic nerve in participants underwent reverse shoulder arthroplasty surgery.

Trial Health

87
On Track

Trial Health Score

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

Enrollment
8

participants targeted

Target at below P25 for all trials

Timeline
Completed

Started Nov 2023

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

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Start

First participant enrolled

November 1, 2023

Completed
16 days until next milestone

First Submitted

Initial submission to the registry

November 17, 2023

Completed
7 days until next milestone

First Posted

Study publicly available on registry

November 24, 2023

Completed
4 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

March 30, 2024

Completed
2 months until next milestone

Study Completion

Last participant's last visit for all outcomes

May 30, 2024

Completed
Last Updated

December 19, 2024

Status Verified

December 1, 2024

Enrollment Period

5 months

First QC Date

November 17, 2023

Last Update Submit

December 16, 2024

Conditions

Diaphragmatic ParalysisAnterior Suprascapular Nerve BlockSuperficial Cervical Plexus BlockPhrenic Nerve Paralysis

Keywords

diaphragmatic paralysisanterior suprascapular nerve blocksuperficial cervical plexus blockreverse shoulder replacementshoulder pain

Outcome Measures

Primary Outcomes (1)

  • Postoperative Change Ratio of Diaphragm Thickness Fraction

    Postoperative Change Ratio of Diaphragm Thickness Fraction (%) at Postoperatively 30th. min.

    Postoperatively 30th. min.

Secondary Outcomes (10)

  • Pain Assessment with Visual Analogue Scale at postoperatively 30th. Min.

    Postoperatively 30th. min

  • Pain Assessment with Visual Analogue Scale at postoperatively 4th. Hours.

    Postoperatively 4th. hour

  • Pain Assessment with Visual Analogue Scale at postoperatively 6th. Hours.

    Postoperatively 6th. hour

  • Pain Assessment with Visual Analogue Scale at postoperatively 12th. Hours.

    Postoperatively 12th. hour

  • Pain Assessment with Visual Analogue Scale at postoperatively 24th. Hours.

    Postoperatively 24th. hour

  • +5 more secondary outcomes

Other Outcomes (2)

  • Patient Satisfaction with 5 point Likert Patient Satisfaction scale at postoperatively 24th. Hours

    Postoperatively 24th hour

  • Postoperative Nausea and Vomiting

    During Postoperatively 24 hour

Study Arms (1)

Group 1

Group 1: Combined Anterior Suprascapular Nerve Block and Superficial Cervical Plexus Block

Eligibility Criteria

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

Participants who underwent combined anterior suprascapular nerve block and superficial cervical plexus block in reverse shoulder arthroplasty surgery

You may qualify if:

  • Population is defined by database within a given time frame
  • Participants who underwent combined anterior suprascapular nerve block and superficial cervical plexus block in reverse shoulder arthroplasty surgery
  • Participants aged 18-80
  • ASA I-II-III

You may not qualify if:

  • ASA score \> III
  • Pediatric individuals under 18 years of age
  • Individuals who are pregnant
  • Known diaphragmatic paralysis
  • Had an allergy or toxicity to local anesthetic agents
  • Have an opioid drug allergy

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Istanbul Medeniyet University

Istanbul, 34722, Turkey (Türkiye)

Location

MeSH Terms

Conditions

Respiratory ParalysisShoulder Pain

Condition Hierarchy (Ancestors)

Respiratory InsufficiencyRespiration DisordersRespiratory Tract DiseasesParalysisNeurologic ManifestationsNervous System DiseasesSigns and SymptomsPathological Conditions, Signs and SymptomsArthralgiaJoint DiseasesMusculoskeletal DiseasesPain

Study Officials

  • Ebru Girgin Dinç

    Istanbul Medeniyet University

    STUDY DIRECTOR

Study Design

Study Type
observational
Observational Model
CASE ONLY
Time Perspective
RETROSPECTIVE
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
Principal Investigator

Study Record Dates

First Submitted

November 17, 2023

First Posted

November 24, 2023

Study Start

November 1, 2023

Primary Completion

March 30, 2024

Study Completion

May 30, 2024

Last Updated

December 19, 2024

Record last verified: 2024-12

Data Sharing

IPD Sharing
Will not share

Locations

TU(1)