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NCT Number: NCT06641167

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

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

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Key information

Conditions

Anesthesia, Local

Age range

18 year and older

Sex eligibility

All sexes

Study type

Observational

Primary location

Hôpital privé Claude Galien

Quincy-sous-Sénart, 91480, France

Location contact

Yoann ELMALEH, MD

CONTACT

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

Shoulder Surgery

Procedure

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

Primary outcomes

  1. 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

Secondary outcomes

  1. Incision pain

    Time frame: 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)

  2. Postoperative pain

    Time frame: Hour 2

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

  3. Postoperative pain

    Time frame: Hour 6

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

  4. Postoperative pain

    Time frame: Hour 24

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

  5. Sedative medication

    Time frame: Hour 24

    Amount of sedative medication administered

  6. Analgesic consumption

    Time frame: Hour 24

    Amount of analgesics consumed within the 24 hours following surgery

  7. Intervention duration

    Time frame: 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)

  8. Stay in the PACU duration

    Time frame: 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)

  9. Adverse events

    Time frame: Hour 24

    Perioperative and immediate postoperative adverse events

Study contacts

Contact information is provided by the study sponsor or research team.

Yoann ELMALEH, MD

CONTACT

[email protected]

01 69 39 15 53 ext. 33

Sponsors and collaborators

Lead sponsor

GCS Ramsay Santé pour l'Enseignement et la Recherche

Other

Registry information

Acronym: CAESAR

Important dates

Study start
2024
Primary completion
2025
Study completion
2025
First posted
Oct 15, 2024
Registry last updated
Oct 15, 2024

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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