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Rotator Cuff Repair Under Isolated Loco-regional Anesthesia Versus General Anesthesia Combined With Loco-regional Anesthesia: Randomized Controlled Trial of Superiority. (AGORA)
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.
Details
| Lead sponsor | Elsan |
|---|---|
| Phase | NA |
| Status | RECRUITING |
| Enrolment | 80 |
| Start date | 2023-11-13 |
| Completion | 2025-07 |
Conditions
- Shoulder Cuff Surgical Repair
Interventions
- Arthroscopic rotator cuff repair
- naropeine or chirocaine (Arthroscopic rotator cuff repair under LRA associated to GA)
- naropeine or chirocaine (Arthroscopic rotator cuff repair under LRA)
Primary outcomes
- compare systolic blood pressure (SBP) measured during surgery between patients operated for rotator cuff repair under LRA alone and those under LRA and GA. — Day 0
The main evaluation criterion is the average systolic pressures, measured in the supine position, before loco-regional anesthesia, in the induction room, then in the prone position on entering the operating room, then in a semi-sitting position, and every 5 minutes during the surgery, the duration of which varies according to the patient between 30 and 45 minutes. The average of the systolic blood pressures will be calculated on the available data, with a minimum of 4 values.
Countries
France