Rotator Cuff Repair Under Isolated Loco-regional Anesthesia
ConditionShoulder Cuff Surgical Repair
Trial statusRecruiting
Trial phaseNot applicable
Trial typeInterventional
Biological sexAll
Age18+
SponsorElsan
About this trial
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.
Eligibility criteria
Qualifiers
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).
Disqualifiers
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
Trial design
Treatments tested in this trial
- 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)
Treatment groups
80 Participants
are divided into 2 treatment groupsSponsors and collaborators
Source ClinicalTrials.gov