Repair of shoulder rotator cuff using localized anesthesia
Rotator Cuff Repair Under Isolated Loco-regional Anesthesia Versus General Anesthesia Combined With Loco-regional Anesthesia: Randomized Controlled Trial of Superiority.
This study tests if using localized anesthesia during rotator cuff repair surgery can help patients maintain better blood pressure and have similar results compared to the usual method that includes general anesthesia.
Quick facts
| Phase | Not applicable |
|---|---|
| Study type | Interventional |
| Enrollment | 80 (estimated) |
| Ages | 18 Years and up |
| Sex | All |
| Sponsor | Elsan Academic / other |
| Locations | 4 sites (Nantes and 3 other locations) |
| Trial ID | NCT05848375 on ClinicalTrials.gov |
What this trial studies
This clinical trial investigates the effectiveness of performing rotator cuff repair surgery using isolated loco-regional anesthesia compared to the traditional method that combines it with general anesthesia. The study aims to assess blood pressure levels during surgery, as loco-regional anesthesia allows for better maintenance of blood pressure and real-time clinical assessment since patients remain conscious. The trial includes patients with specific types of rotator cuff injuries that require surgical intervention. The goal is to determine if this approach can provide similar outcomes while minimizing the risks associated with general anesthesia.
Who should consider this trial
Good fit: Ideal candidates are adults aged 18 and over with specific supraspinatus lesions requiring arthroscopic rotator cuff repair.
Not a fit: Patients with a history of shoulder surgery, advanced osteoarthritis, or contraindications to loco-regional or general anesthesia may not benefit from this study.
Why it matters
Potential benefit: If successful, this approach could lead to safer surgical procedures with fewer complications related to general anesthesia for patients undergoing rotator cuff repair.
How similar studies have performed: Other studies have shown promising results with similar approaches to anesthesia in orthopedic surgeries, suggesting potential for success in this trial.
Eligibility criteria
Show full inclusion / exclusion criteria
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. * Protected participant: adult under guardianship, curatorship or other legal protection, deprived of liberty by judicial or administrative decision. * Pregnant, breastfeeding or parturient woman. * Participant hospitalized without consent.
Where this trial is running
Nantes and 3 other locations
- Clinique Bretéché — Nantes, France (Recruiting)
- CHP St Grégoire — Saint-Grégoire, France (Not_yet_recruiting)
- Clinique Belledonne — Saint-Martin-d'Hères, France (Recruiting)
- Hôpital privé St Claude — Saint-Quentin, France (Recruiting)
Study contacts
- Principal investigator: Laurent BAVEREL, Dr — Clinique Bretéché ELSAN
- Study coordinator: Vincent WYART, MSc
- Email: vincent.wyart@elsan.care
- Phone: 0240958176
How to participate
- Review the eligibility criteria above with your treating physician.
- Visit the official trial page on ClinicalTrials.gov for the most current contact information and recruitment status.
- Contact the listed study coordinator or principal investigator to request pre-screening. Pre-screening is free and never obligates you to enroll.