Actively Recruiting
Rotator Cuff Repair Under Isolated Loco-regional Anesthesia
Led by Elsan · Updated on 2024-06-13
80
Participants Needed
4
Research Sites
85 weeks
Total Duration
On this page
AI-Summary
What this Trial Is About
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
Official Title
Rotator Cuff Repair Under Isolated Loco-regional Anesthesia
Who Can Participate
Eligibility Criteria
You may qualify if you...
- Patient, male or female, aged 18 and over
- Supraspinatus or supraspinatus and infraspinatus lesions requiring arthroscopic rotator cuff repair
- Tendon is non-retracted or minimally retracted (Patte score ≤ 2)
- Muscle has little or no fatty infiltration (Goutallier classification ≤ 2)
- Affiliated with or beneficiary of a social security scheme
- Provided free, informed, and written consent before study procedures
You will not qualify if you...
- History of surgery on the shoulder to be operated on
- Glenohumeral osteoarthritis stage >1 (Samilson classification)
- Requirement for associated subscapularis repair
- Contraindication to loco-regional anesthesia or general anesthesia
- Preference for a specific type of anesthesia
- Contraindication to day surgery
- Presence of neuropathy
- History of vagal, emotional, or stress-related discomfort
- Severe physical or psychological health impairment affecting study compliance
- Participation in another research study
- Currently excluded from another ongoing research study
- Under legal protection such as guardianship or deprived of liberty
- Pregnant, breastfeeding, or parturient women
- Hospitalized without consent
AI-Screening
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Trial Site Locations
Total: 4 locations
1
Clinique Bretéché
Nantes, France, 44000
Actively Recruiting
2
CHP St Grégoire
Saint-Grégoire, France, 35760
Not Yet Recruiting
3
Clinique Belledonne
Saint-Martin-d'Hères, France
Actively Recruiting
4
Hôpital privé St Claude
Saint-Quentin, France
Actively Recruiting
Research Team
V
Vincent WYART, MSc
CONTACT
How is the study designed?
Study Type
INTERVENTIONAL
Masking
SINGLE
Allocation
RANDOMIZED
Model
PARALLEL
Primary Purpose
TREATMENT
Number of Arms
2
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