NCT06641167

Brief Summary

This is a prospective, single-center, observational study. The inclusion period is set at 12 months.

Trial Health

43
At Risk

Trial Health Score

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

Trial has exceeded expected completion date
Enrollment
96

participants targeted

Target at P50-P75 for all trials

Timeline
Completed

Started Dec 2024

Shorter than P25 for all trials

Geographic Reach
1 country

1 active site

Status
not yet recruiting

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

First Submitted

Initial submission to the registry

October 11, 2024

Completed
4 days until next milestone

First Posted

Study publicly available on registry

October 15, 2024

Completed
2 months until next milestone

Study Start

First participant enrolled

December 1, 2024

Completed
12 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

November 30, 2025

Completed
1 day until next milestone

Study Completion

Last participant's last visit for all outcomes

December 1, 2025

Completed
Last Updated

October 15, 2024

Status Verified

October 1, 2024

Enrollment Period

12 months

First QC Date

October 11, 2024

Last Update Submit

October 11, 2024

Conditions

Anesthesia, Local

Outcome Measures

Primary Outcomes (1)

  • Soft point position

    The primary outcome is the position of the soft point in relation to the anesthetized area mapped by loco-regional anesthesia

    Hour 24

Secondary Outcomes (9)

  • Incision pain

    Hour 24

  • Postoperative pain

    Hour 2

  • Postoperative pain

    Hour 6

  • Postoperative pain

    Hour 24

  • Sedative medication

    Hour 24

  • +4 more secondary outcomes

Interventions

Shoulder surgeryPROCEDURE

shoulder surgery by arthroscopic approach under locoregional anesthesia combining an interscalene block and a superficial cervical plexus block

Eligibility Criteria

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

population of patients undergoing shoulder surgery by arthroscopic approach under locoregional anesthesia combining an interscalene block and a superficial cervical plexus block (supraclavicular nerve)

You may qualify if:

  • Patient aged 18 years or older
  • Patient informed about the study and who has not opposed the use of their personal medical data
  • Patient scheduled for arthroscopic shoulder surgery

You may not qualify if:

  • Allergy to local anesthetics or epinephrine
  • Contraindications to Interscalene Block (e.g., respiratory disease, pneumothorax, pneumonectomy, phrenic or recurrent laryngeal nerve paralysis)
  • Coagulation disorder
  • Patients unable to understand the study information and objectives: dementia, psychosis, consciousness disorders, non-French-speaking patients
  • Patients under legal protection measures (guardianship, curatorship) or deprived of liberty by judicial or administrative decision

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Hôpital privé Claude Galien

Quincy-sous-Sénart, 91480, France

Location

Central Study Contacts

Yoann ELMALEH, MD

CONTACT

01 69 39 15 53yoann.d.elmaleh@gmail.com

Study Design

Study Type
observational
Observational Model
OTHER
Time Perspective
PROSPECTIVE
Sponsor Type
OTHER
Responsible Party
SPONSOR

Study Record Dates

First Submitted

October 11, 2024

First Posted

October 15, 2024

Study Start

December 1, 2024

Primary Completion

November 30, 2025

Study Completion

December 1, 2025

Last Updated

October 15, 2024

Record last verified: 2024-10

Data Sharing

IPD Sharing
Will not share

Locations

FR(1)