Interest of Soft Point Anesthesia in Association With Locoregional Anesthesia in Arthroscopic Shoulder Surgery (CAESAR)

October 11, 2024 updated by: GCS Ramsay Santé pour l'Enseignement et la Recherche
This is a prospective, single-center, observational study. The inclusion period is set at 12 months.

Study Overview

Status

Not yet recruiting

Conditions

Intervention / Treatment

Study Type

Observational

Enrollment (Estimated)

96

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Contact

Study Locations

  • France
      • Quincy-sous-Sénart, France, 91480
        • Hôpital Privé Claude Galien
        • Contact:
          • Yoann ELMALEH, MD

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

  • Adult
  • Older Adult

Accepts Healthy Volunteers

No

Sampling Method

Non-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)

Description

Inclusion Criteria:

  • 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

Exclusion Criteria:

  • 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

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Soft point position
Time Frame: Hour 24
The primary outcome is the position of the soft point in relation to the anesthetized area mapped by loco-regional anesthesia
Hour 24

Secondary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Incision pain
Time Frame: Hour 24
Assessment of incision pain using a simple numerical scale (NRS) from 0 (no pain/not uncomfortable) to 10 (worst possible pain/most uncomfortable)
Hour 24
Postoperative pain
Time Frame: Hour 2
Assessment of postoperative pain using a simple numerical scale (NRS) from 0 (no pain) to 10 (worst possible pain)
Hour 2
Postoperative pain
Time Frame: Hour 6
Assessment of postoperative pain using a simple numerical scale (NRS) from 0 (no pain) to 10 (worst possible pain)
Hour 6
Postoperative pain
Time Frame: Hour 24
Assessment of postoperative pain using a simple numerical scale (NRS) from 0 (no pain) to 10 (worst possible pain)
Hour 24
Sedative medication
Time Frame: Hour 24
Amount of sedative medication administered
Hour 24
Analgesic consumption
Time Frame: Hour 24
Amount of analgesics consumed within the 24 hours following surgery
Hour 24
Intervention duration
Time Frame: Hour 24
Duration of the procedure and stay in the Post anesthesia care unit (the procedure duration is defined as the time between the start of the incision and the end of suturing)
Hour 24
Stay in the PACU duration
Time Frame: Hour 24
Duration of the procedure and stay in the Post anesthesia care unit (the procedure duration is defined as the time between the start of the incision and the end of suturing)
Hour 24
Adverse events
Time Frame: Hour 24
Perioperative and immediate postoperative adverse events
Hour 24

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

GCS Ramsay Santé pour l'Enseignement et la Recherche

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Estimated)

December 1, 2024

Primary Completion (Estimated)

November 30, 2025

Study Completion (Estimated)

December 1, 2025

Study Registration Dates

First Submitted

October 11, 2024

First Submitted That Met QC Criteria

October 11, 2024

First Posted (Actual)

October 15, 2024

Study Record Updates

Last Update Posted (Actual)

October 15, 2024

Last Update Submitted That Met QC Criteria

October 11, 2024

Last Verified

October 1, 2024

More Information

Terms related to this study

Other Study ID Numbers

  • 2024-06-007

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

NO

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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