AzTrials
AzTrials

Anesthesia, LocalCAESARNCT06641167

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

An observational study of Anesthesia, Local, run by GCS Ramsay Santé pour l'Enseignement et la Recherche at 1 site in France.

Not yet recruiting

Opening soon. The study is approved but enrolment has not started yet. Sites may already take enquiries.

Sites and contacts
Official record
Search all trials

Trial summary

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

Who is it for?
Ages 18 years and older
Conditions the study is for
Anesthesia, Local
What is being tested?
Shoulder surgery
Type of treatment
Surgery or procedure
How many people
96 participants
Where
1 siteFrance
Study dates
1 Dec 2024to 1 Dec 2025
Phase
Observational
Are there results?
Not yet: the study is under way

Key requirements

Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.

  • Ages 18 years and older
  • All sexes
  • No healthy volunteers
  • Adult, Older adult

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)

Who may be able to join

  • 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

Who cannot join

  • 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

Trial locations and contacts

1 site in 1 country. Contact the study team or a site near you to ask about taking part.

Yoann ELMALEH, MD contact

01 69 39 15 53 ext. 33

yoann.d.elmaleh@gmail.com

France1 site

  • Hôpital privé Claude Galien

    Quincy-sous-Sénart, 91480

    Yoann ELMALEH, MD

Other trials in France

About this study

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

Being tested
Shoulder surgery

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

  • Shoulder surgeryProcedure or surgery

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

What is being measured

The primary outcome is the main question the study is designed to answer.

  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

    Measured: Hour 24

Secondary outcomes (9)

  1. Incision pain

    Assessment of incision pain using a simple numerical scale (NRS) from 0 (no pain/not uncomfortable) to 10 (worst possible pain/most uncomfortable)

    Measured: Hour 24

  2. Postoperative pain

    Assessment of postoperative pain using a simple numerical scale (NRS) from 0 (no pain) to 10 (worst possible pain)

    Measured: Hour 2

  3. Postoperative pain

    Assessment of postoperative pain using a simple numerical scale (NRS) from 0 (no pain) to 10 (worst possible pain)

    Measured: Hour 6

  4. Postoperative pain

    Assessment of postoperative pain using a simple numerical scale (NRS) from 0 (no pain) to 10 (worst possible pain)

    Measured: Hour 24

  5. Sedative medication

    Amount of sedative medication administered

    Measured: Hour 24

  6. Analgesic consumption

    Amount of analgesics consumed within the 24 hours following surgery

    Measured: Hour 24

  7. Intervention duration

    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)

    Measured: Hour 24

  8. Stay in the PACU duration

    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)

    Measured: Hour 24

  9. Adverse events

    Perioperative and immediate postoperative adverse events

    Measured: Hour 24

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

  1. First posted15 Oct 2024
  2. Study start1 Dec 2024 (estimated)
  3. Primary completion30 Nov 2025 (estimated)
  4. Study completion1 Dec 2025 (estimated)

Resources

More details

For doctors and researchers: how the study is designed, who runs it, and its registry IDs.

Study design
Study type
Observational
Observational model
Other
Time perspective
Prospective
Enrolment
96 participants (estimated)
IDs, dates and publications
ClinicalTrials.gov ID
NCT06641167
Sponsor's protocol ID
2024-06-007
Acronym
CAESAR
Status last verified
Oct 2024
First submitted
11 Oct 2024
Last updated
15 Oct 2024
Results posted
No
Data monitoring committee
No
FDA-regulated drug
No
FDA-regulated device
No
Individual data sharing
No

Questions about this trial

What is this clinical trial studying?

An observational study of Anesthesia, Local, run by GCS Ramsay Santé pour l'Enseignement et la Recherche at 1 site in France.

The full registered description is in the About this study section and the official record.

Who may be eligible to take part?

The sponsor lists 3 inclusion and 5 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.

Is this clinical trial currently recruiting?

The record says: opening soon, as of the sponsor's last update on 15 Oct 2024. Status can change between updates, so confirm with the study contact before making plans.

Where is the study taking place?

The record lists 1 site in France. Whether a site is taking part right now should be confirmed with that site. See every site.

What are the possible benefits and risks?

They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.

Are results available for this study?

This study is still under way. Results are not available in the source record yet.

How can a doctor refer a patient or contact the research team?

Contact Yoann ELMALEH, MD (01 69 39 15 53 ext. 33, yoann.d.elmaleh@gmail.com), or a site near the patient. AzTrials does not enrol participants or take referrals.

What does the primary outcome measure?

Soft point position (time frame: Hour 24). It is what the study was designed to measure, not a finding.

Where can I read the original study information?

On the ClinicalTrials.gov record for NCT06641167.

Does a listing mean the treatment is approved or proven to work?

No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.

How often is this information updated?

AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 15 Oct 2024; AzTrials last refreshed its copy on 8 Nov 2026.

AzTrials uses cookies for analytics and advertising. You can accept or reject them; the site works either way. Privacy Policy.

Free account

Log in to keep searching

You’ve used your 3 free searches. AzTrials is free: log in or create a free account to keep searching clinical trials and save the ones you want to follow.

Create a free accountLog in