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
This trial does not accept healthy volunteersQualifiers
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
Design model
Parallel
Treatments tested in this trial
Arthroscopic rotator cuff repair
Procedure/SurgeryThe operation involves systematic acromioplasty during the supra +/- infraspinatus repair and sometimes requires a tenotomy of the long biceps if it is pathological.
naropeine or chirocaine (Arthroscopic rotator cuff repair under LRA associated to GA)
DrugLoco Regional Anesthesia is performed by injecting anesthetic (between 10 and 20 ml of naropeine or chirocaine) into the interscalene nerve block under ultrasound guidance associated to General Anesthesia performed by injection of diprivan and ultiva.
naropeine or chirocaine (Arthroscopic rotator cuff repair under LRA)
DrugLoco Regional Anesthesia is performed by injecting anesthetic (between 10 and 20 ml of naropeine or chirocaine) into the interscalene nerve block under ultrasound guidance
Treatment groups
80 Participants
are divided into 2 treatment groupsGroup A: Loco regional anesthesia aloneExperimental treatment 2 interventions
Group B: Loco regional anesthesia associated to general anesthesiaActive comparator 2 interventions
Trial outcomes
Primary outcomes
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.
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.
Time frame
Day 0Secondary outcomes
1
Hydraulic pressure during surgery
The difference in pressure administered by the arthrpomp between the beginning and the end of the surgery
Time frame
Day 02
The intensity of bleeding during surgery
The intensity of bleeding during surgery, assessed by the number of washes performed
Time frame
Day 03
Sedation administered to the patient during surgery
Sedation assessed by the type of sedation administered to the patient: no sedation, hypnotic sedation, morphine sedation
Time frame
Day 04
Patient pain after surgery
Pain is assessed by a visual analogue scale over 100 mm, measured morning and evening the first 3 days after surgery then once on day 7, day 14 and day 21 after surgery.
Time frame
Day 1 to day 21 Source ClinicalTrials.gov