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Rotator Cuff Repair Under Isolated Loco-regional Anesthesia

NCT05848375 · Status: RECRUITING · Phase: NA · Type: INTERVENTIONAL · Enrollment: 80

Last updated 2024-06-13

No results posted yet for this study

Summary

Damage to the tendons of the shoulder, called rotator cuff, causes pain and loss of strength that may require surgery. This operation is performed under general anesthesia combined with loco-regional anesthesia of the shoulder. Indeed, this loco-regional anesthesia makes it possible to specifically suppress the sensation of pain in the shoulder for several hours after surgery. General anesthesia is produced by injecting drugs intravenously and breathing anesthetic vapors. Repair of the rotator cuff under loco-regional anesthesia alone is performed by several surgeons in France and is recommended by international experts. If blood pressure is artificially lowered during general anesthesia, loco-regional anesthesia alone allows maintenance of blood pressure and real-time clinical assessment since the patient is conscious.

The purpose of the research is to compare the blood pressure measured during surgery of patients operated under loco-regional anesthesia alone or associated with general anesthesia, two common practices of surgical teams.

Conditions

  • Shoulder Cuff Surgical Repair

Interventions

PROCEDURE

Arthroscopic rotator cuff repair

The operation involves systematic acromioplasty during the supra +/- infraspinatus repair and sometimes requires a tenotomy of the long biceps if it is pathological.

DRUG

naropeine or chirocaine (Arthroscopic rotator cuff repair under LRA associated to GA)

Loco Regional Anesthesia is performed by injecting anesthetic (between 10 and 20 ml of naropeine or chirocaine) into the interscalene nerve block under ultrasound guidance associated to General Anesthesia performed by injection of diprivan and ultiva.

DRUG

naropeine or chirocaine (Arthroscopic rotator cuff repair under LRA)

Loco Regional Anesthesia is performed by injecting anesthetic (between 10 and 20 ml of naropeine or chirocaine) into the interscalene nerve block under ultrasound guidance

Sponsors & Collaborators

  • Elsan

    lead OTHER

Principal Investigators

  • Laurent BAVEREL, Dr · Clinique Bretéché ELSAN

Study Design

Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
SINGLE
Model
PARALLEL

Eligibility

Min Age
18 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2023-11-13
Primary Completion
2024-12-31
Completion
2025-07-31

Countries

  • France

Study Locations

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Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT05848375 on ClinicalTrials.gov