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.
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?
- None posted in the registry
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.
France1 site
Hôpital privé Claude Galien
Quincy-sous-Sénart, 91480
Yoann ELMALEH, MD
About this study
This is a prospective, single-center, observational study. The inclusion period is set at 12 months.
- Conditions
- Anesthesia, Local
- 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.
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)
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
Postoperative pain
Assessment of postoperative pain using a simple numerical scale (NRS) from 0 (no pain) to 10 (worst possible pain)
Measured: Hour 2
Postoperative pain
Assessment of postoperative pain using a simple numerical scale (NRS) from 0 (no pain) to 10 (worst possible pain)
Measured: Hour 6
Postoperative pain
Assessment of postoperative pain using a simple numerical scale (NRS) from 0 (no pain) to 10 (worst possible pain)
Measured: Hour 24
Sedative medication
Amount of sedative medication administered
Measured: Hour 24
Analgesic consumption
Amount of analgesics consumed within the 24 hours following surgery
Measured: Hour 24
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
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
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.
- First posted15 Oct 2024
- Study start1 Dec 2024 (estimated)
- Primary completion30 Nov 2025 (estimated)
- Study completion1 Dec 2025 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Anesthesia, LocalStudies of the same condition, open and under way.
- More trials run by GCS Ramsay Santé pour l'Enseignement et la RechercheThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
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)
Sponsor and investigators
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
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
Study at a glance
From the registry record, last updated by the sponsor on 15 Oct 2024. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Interest of Soft Point Anesthesia in Association With Locoregional Anesthesia in Arthroscopic Shoulder Surgery
- ClinicalTrials.gov ID
- NCT06641167
- Acronym / sponsor ID
- CAESAR / 2024-06-007
- Conditions
- Anesthesia, Local
- Study type
- Observational
- Recruitment status
- Unknown status
- Enrolment
- 96 participants (estimated)
- Lead sponsor
- GCS Ramsay Santé pour l'Enseignement et la RechercheUniversity, hospital or other
- Study start
- 1 Dec 2024 (estimated)
- Primary completion
- 30 Nov 2025 (estimated)
- Study completion
- 1 Dec 2025 (estimated)
- First posted
- 15 Oct 2024 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
This is a prospective, single-center, observational study. The inclusion period is set at 12 months.
Study design
- Observational model
- Other
- Time perspective
- Prospective
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- 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)
Key inclusion criteria (3 listed)
- 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
Key exclusion criteria (5 listed)
- 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
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Shoulder surgeryshoulder surgery by arthroscopic approach under locoregional anesthesia combining an interscalene block and a superficial cervical plexus block | Procedure or surgery | – |
Primary outcome
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
9 secondary outcomes
Incision pain
Time frame: Hour 24
Postoperative pain
Time frame: Hour 2
Postoperative pain
Time frame: Hour 6
Postoperative pain
Time frame: Hour 24
Sedative medication
Time frame: Hour 24
Analgesic consumption
Time frame: Hour 24
Intervention duration
Time frame: Hour 24
Stay in the PACU duration
Time frame: Hour 24
Adverse events
Time frame: Hour 24
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 15 Oct 2024.
- Individual participant dataSharing planned: No
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
1 site in 1 country: see every site and its status.
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: status not confirmed, 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?
Results are not available in the source record.
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?
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.