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RECRUITING
NCT05848375
NA

Rotator Cuff Repair Under Isolated Loco-regional Anesthesia

Sponsor: Elsan

View on ClinicalTrials.gov

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.

Official title: Rotator Cuff Repair Under Isolated Loco-regional Anesthesia Versus General Anesthesia Combined With Loco-regional Anesthesia: Randomized Controlled Trial of Superiority.

Key Details

Gender

All

Age Range

18 Years - Any

Study Type

INTERVENTIONAL

Enrollment

80

Start Date

2023-11-13

Completion Date

2025-07

Last Updated

2024-06-13

Healthy Volunteers

No

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

Locations (4)

Clinique Bretéché

Nantes, France

CHP St Grégoire

Saint-Grégoire, France

Clinique Belledonne

Saint-Martin-d'Hères, France

Hôpital privé St Claude

Saint-Quentin, France