Clinical trial NCT05848375: Rotator Cuff Repair Under Isolated Loco-regional Anesthesia
Official title: Rotator Cuff Repair Under Isolated Loco-regional Anesthesia Versus General Anesthesia Combined With Loco-regional Anesthesia: Randomized Controlled Trial of Superiority.
Study type: INTERVENTIONAL
Overall status: RECRUITING
Phase: NA
Conditions: Shoulder Cuff Surgical Repair
Lead sponsor: Elsan
Sponsor class: OTHER
First posted: 2023-05-08
Enrollment: 80
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Intervention model description: Interventional study, randomized in two parallel groups, multicenter (trial of superiority) :

The research procedure for arthroscopic rotator cuff repair is performed under local regional anesthesia alone without general anesthesia. LRA is performed by injecting anesthetic into the interscalene nerve block under ultrasound guidance. This LRA can be accompanied by hypnotic or morphine sedation. The comparison procedure is arthroscopic rotator cuff repair performed under LRA and GA
Primary purpose: TREATMENT

Brief 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.

Detailed description: Rotator cuff injury is a common pathology with a prevalence of 30% in the general population. The main symptom of a rotator cuff tear is pain. It can be sharp when it is accidental or manifests itself when the shoulder is solicited, frequently waking the patient at night. Conservative treatment may be offered in some patients, but in the event of prolonged pain or significant lesions, surgery is recommended.

The gold standard treatment for rotator cuff tears is arthroscopic surgery. The anesthesia performed is a general anesthesia (GA) associated with a loco-regional anesthesia (LRA) of the shoulder. The injection of anesthetics into the brachial plexus before general anesthesia allows better control of postoperative pain. GA is given to patients after LRA, using a combination of hypnotic agents, curare and morphine, both for induction and maintenance of anaesthesia.

GA has several advantages: patients with a rotator cuff tear do not experience pain during surgery. For the surgeon, the GA is comfortable since the patient remains motionless throughout the duration of the surgery. Nevertheless, this requires the availability of these drugs but also increases the risk of viral contamination, mainly due to COVID-19. During the first wave of the pandemic in March 2020, several countries in Europe were in need of curare and hypnotic agents. These specific drugs for anesthesia were administered in priority to patients requiring emergency GA or for carcinological surgery. Rotator cuff tears have therefore become irreparable, due to tendon retraction or fatty infiltration into the muscle, in patients with surgery postponed for several months.

The recent development of ultrasound facilitates the realization of the LRA, allowing a better identification of the brachial plexus, for the injection of the anesthetic, resulting in a complete anesthesia of the shoulder. Even if the efficacy of LRA alone has already been described by several groups in non-GA shoulder surgeries, before 2020 it was rarely performed to repair rotator cuff tears under arthroscopy.

Rotator cuff repair under LRA alone has been performed by several surgeons in France since COVID-19 and is now recommended by international experts. Particular attention should be paid to positioning the patient, maintaining cerebral perfusion and oxygenation. Methods of measuring cerebral perfusion or oxygenation are too slow for real-time assessment, so it is recommended to avoid general anesthesia to allow continuous clinical neurological assessment. The research hypothesis is that rotator cuff repair surgery under LRA alone is possible while maintaining the patient's blood pressure

Eligibility 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.

Primary outcomes:
measure: compare systolic blood pressure (SBP) measured during surgery between patients operated for rotator cuff repair under LRA alone and those under LRA and GA.
timeFrame: Day 0
Secondary outcomes:
measure: Hydraulic pressure during surgery
timeFrame: Day 0
measure: The intensity of bleeding during surgery
timeFrame: Day 0
measure: Sedation administered to the patient during surgery
timeFrame: Day 0
measure: Patient pain after surgery
timeFrame: Day 1 to day 21
measure: Patient satisfaction 3 weeks after surgery
timeFrame: 3 weeks
measure: Adverse events between patients operated on LRA alone and patients on LRA and GA.
timeFrame: Day 0 to 6 months
measure: Medication taken for pain between these same groups of patients in the 21 days following surgery.
timeFrame: Day 1 to day 21
Other outcomes:
Locations:
city: Nantes
country: France
facility: Clinique Bretéché
city: Saint-Grégoire
country: France
facility: CHP St Grégoire
city: Saint-Martin-d'Hères
country: France
facility: Clinique Belledonne
city: Saint-Quentin
country: France
facility: Hôpital privé St Claude
Study officials:
affiliation: Clinique Bretéché ELSAN
name: Laurent BAVEREL, Dr
role: PRINCIPAL_INVESTIGATOR
References: