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Not yet recruiting NCT06641167

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

— Observational Anesthesia, Local

For patients and families

In plain language

An automatic summary of structured registry data. It is an orientation aid, not a substitute for the official protocol or a physician assessment.

What is being studied
The protocol lists: Shoulder surgery.
Who it may be relevant to
Registry conditions: Anesthesia, Local. Basic parameters: from 18 years · All.
What needs checking
Age, condition and sex are only basic indicators. Prior treatment, laboratory values and other mandatory requirements appear in the eligibility criteria below.
Where it takes place
France
Next step
Save the trial, show it to the treating physician, and confirm current recruitment with the study center. Costs, documents and travel →

Unsure about the terms? Read our patient guide →

Overview

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

Interventions

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

Primary outcome measures

  • Soft point position [Time frame: Hour 24]
Secondary outcome measures (9)
  • 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]

Eligibility criteria

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

Criteria are shown verbatim from the registry (in English). Final eligibility is always assessed by the study center.

Healthy volunteers: No

Study design

Observational model
Other

Study locations

France · 1 center
  • Hôpital privé Claude Galien — Quincy-sous-Sénart

Identifiers

NCT: NCT06641167 · 2024-06-007

Primary sources (government registries)

View this study on ClinicalTrials.gov ↗