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

Not yet recruiting

• Conditions: Anesthesia, Local

• Registration Number: NCT06641167
• Lead Sponsor: GCS Ramsay Santé pour l'Enseignement et la Recherche

Brief Summary

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

Detailed Description

Not available

Study Timeline

• Status Verified: 2024-10
• Study First Submitted: 2024-10-11
• Study First Submitted QC: 2024-10-11
• Last Update Submitted: 2024-10-11
• Study First Posted: 2024-10-14
• Last Update Posted: 2024-10-14
• Study Start: 2024-12-01
• Primary Completion: 2025-11-30
• Study Completion: 2025-12-01

Recruitment & Eligibility

• Status: NOT_YET_RECRUITING
• Sex: All
• Target Recruitment: 96

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 & Design

• Study Type: OBSERVATIONAL
• Study Design: Not specified

Primary Outcome Measures

Name	Time	Method
Soft point position	Hour 24	The primary outcome is the position of the soft point in relation to the anesthetized area mapped by loco-regional anesthesia

Secondary Outcome Measures

Name	Time	Method
Stay in the PACU duration	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)
Adverse events	Hour 24	Perioperative and immediate postoperative adverse events
Intervention duration	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)
Incision pain	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)
Postoperative pain	Hour 24	Assessment of postoperative pain using a simple numerical scale (NRS) from 0 (no pain) to 10 (worst possible pain)
Sedative medication	Hour 24	Amount of sedative medication administered
Analgesic consumption	Hour 24	Amount of analgesics consumed within the 24 hours following surgery

Trial Locations

Locations (1)

Hôpital privé Claude Galien; 🇫🇷 Quincy-sous-Sénart, France