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

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

Status
Not yet recruiting
Phases
Unknown
Study type
Observational
Source
ClinicalTrials.gov
Registry ID
NCT06641167
Acronym
CAESAR
Enrollment
96
Registered
2024-10-15
Start date
2024-12-01
Completion date
2025-12-01
Last updated
2024-10-15

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Anesthesia, Local

Brief summary

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

Interventions

PROCEDUREShoulder surgery

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

Sponsors

GCS Ramsay Santé pour l'Enseignement et la Recherche
Lead SponsorOTHER

Study design

Observational model
OTHER
Time perspective
PROSPECTIVE

Eligibility

Sex/Gender
ALL
Age
18 Years to No maximum
Healthy volunteers
No

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

Design outcomes

Primary

MeasureTime frameDescription
Soft point positionHour 24The primary outcome is the position of the soft point in relation to the anesthetized area mapped by loco-regional anesthesia

Secondary

MeasureTime frameDescription
Postoperative painHour 2Assessment of postoperative pain using a simple numerical scale (NRS) from 0 (no pain) to 10 (worst possible pain)
Sedative medicationHour 24Amount of sedative medication administered
Analgesic consumptionHour 24Amount of analgesics consumed within the 24 hours following surgery
Incision painHour 24Assessment of incision pain using a simple numerical scale (NRS) from 0 (no pain/not uncomfortable) to 10 (worst possible pain/most uncomfortable)
Stay in the PACU durationHour 24Duration 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)
Adverse eventsHour 24Perioperative and immediate postoperative adverse events
Intervention durationHour 24Duration 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)

Countries

France

Contacts

Primary ContactYoann ELMALEH, MD
yoann.d.elmaleh@gmail.com01 69 39 15 53

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Feb 4, 2026