Rotator Cuff Repair Under Isolated Loco-regional Anesthesia
France80 participantsStarted 2023-11-13
Plain-language 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.
Who can participate
Age range
18 Years
Sex
ALL
See this in plain English?
AI-rewrites the medical criteria so a patient or caregiver can understand them. Always confirm with the trial site.
Inclusion Criteria:
* Patient, male or female, aged 18 and over
* Patient with a supraspinatus lesion or supraspinatus and infraspinatus lesions requiring surgery for arthroscopic rotator cuff repair, with a non-retracted or minimally retracted tendon (lower stage or = 2 according to the Patte score) and a muscle with little or no fat infiltration (fatty infiltration less than or = 2 according to the Goutallier classification)
* Affiliated participant or beneficiary of a social security scheme.
* Participant having been informed and having given their free, informed and written consent (at the latest on the day of inclusion and before any examination required by the research).
Exclusion Criteria:
* Patient with a history of surgery for the operated shoulder
* Patient with stage \>1 glenohumeral osteoarthritis according to the Samilson classification
* Patient requiring associated subscapularis repair
* Patient with a contraindication to LRA or a contraindication to GA
* Patient wishing a type of anesthesia
* Patient with a contraindication to day surgery
* Patient with neuropathy
* Patients with a history of vagal, emotional or stress-prone discomfort
* Participant whose physical and/or psychological health is severely impaired, which according to the investigator may affect the participant's compliance with the study.
* Patients participating in another research
* Participant in period of exclusion from another research still in progress at the time of inclusion.
* Protec…
Questions worth asking your doctor
Bring these to your next appointment. They're a starting point for a shared conversation — not a sign you qualify or a recommendation to enrol.
1Based on my diagnosis and history, is this trial worth exploring for me — or is there a standard treatment we should try first?
2What does this trial's phase tell us about how much is already known about its safety and benefit?
3What would taking part actually involve for me — visits, tests, time, and travel?
4What are the known and possible risks or side effects I should weigh, and how would they be monitored?
5If this trial isn't the right fit, what other options or trials would you suggest I look into?
Generated to help you prepare — always confirm anything about your own eligibility and care with the study team and your doctor.
Questions for the trial coordinator
The trial coordinator is the person who runs the study day to day. These cover the practical side — logistics, costs, and what taking part would actually mean for your life. The study team confirms whether you meet the criteria; these are questions to ask, not a sign you qualify.
1What does taking part actually involve week to week — how many visits, where, and how long does each one take?
2What costs are covered by the study, and what might I have to pay for myself, including travel, parking, or time off work?
3What happens during screening, and what happens if the study team confirms I don't meet the criteria after those tests?
4Who pays for the scans, blood work, and other tests the trial requires — the study, my insurance, or me?
5How will being in the trial affect my regular care, and will my own doctor stay informed and involved?
6Can I leave the trial at any point if I change my mind, and what would happen to my care if I do?
A starting point for the conversation — always confirm anything about your own eligibility, costs, and care with the study team and your doctor.
What they're measuring
1
compare systolic blood pressure (SBP) measured during surgery between patients operated for rotator cuff repair under LRA alone and those under LRA and GA.