NCT05848375

Rotator Cuff Repair Under Isolated Loco-regional Anesthesia

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

• Status: Recruiting
• Phase: N/A
• Study type: Interventional
• Enrollment: 80 (estimated)
• Sponsor: Elsan · Academic / Other
• Sex: All
• Age: 18 Years
• Healthy volunteers: Not accepted

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.

Detailed description

Rotator cuff injury is a common pathology with a prevalence of 30% in the general population. The main symptom of a rotator cuff tear is pain. It can be sharp when it is accidental or manifests itself when the shoulder is solicited, frequently waking the patient at night. Conservative treatment may be offered in some patients, but in the event of prolonged pain or significant lesions, surgery is recommended. The gold standard treatment for rotator cuff tears is arthroscopic surgery. The anesthesia performed is a general anesthesia (GA) associated with a loco-regional anesthesia (LRA) of the shoulder. The injection of anesthetics into the brachial plexus before general anesthesia allows better control of postoperative pain. GA is given to patients after LRA, using a combination of hypnotic agents, curare and morphine, both for induction and maintenance of anaesthesia. GA has several advantages: patients with a rotator cuff tear do not experience pain during surgery. For the surgeon, the GA is comfortable since the patient remains motionless throughout the duration of the surgery. Nevertheless, this requires the availability of these drugs but also increases the risk of viral contamination, mainly due to COVID-19. During the first wave of the pandemic in March 2020, several countries in Europe were in need of curare and hypnotic agents. These specific drugs for anesthesia were administered in priority to patients requiring emergency GA or for carcinological surgery. Rotator cuff tears have therefore become irreparable, due to tendon retraction or fatty infiltration into the muscle, in patients with surgery postponed for several months. The recent development of ultrasound facilitates the realization of the LRA, allowing a better identification of the brachial plexus, for the injection of the anesthetic, resulting in a complete anesthesia of the shoulder. Even if the efficacy of LRA alone has already been described by several groups in non-GA shoulder surgeries, before 2020 it was rarely performed to repair rotator cuff tears under arthroscopy. Rotator cuff repair under LRA alone has been performed by several surgeons in France since COVID-19 and is now recommended by international experts. Particular attention should be paid to positioning the patient, maintaining cerebral perfusion and oxygenation. Methods of measuring cerebral perfusion or oxygenation are too slow for real-time assessment, so it is recommended to avoid general anesthesia to allow continuous clinical neurological assessment. The research hypothesis is that rotator cuff repair surgery under LRA alone is possible while maintaining the patient's blood pressure

Conditions

• Shoulder Cuff Surgical Repair

Interventions

Type	Name	Description
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

Timeline

• Start date: 2023-11-13
• Primary completion: 2024-12-01
• Completion: 2025-07-01
• First posted: 2023-05-08
• Last updated: 2024-06-13

Locations

4 sites across 1 country: France