Rotator Cuff Repair Under Isolated Loco-regional Anesthesia

NCT05848375 | Recruiting

• 1 other identifier: 2023-A00499-36
• Study Type: interventional
• Target: 80
• Locations: 1 country
• Sites: 4

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.

Conditions

Shoulder Cuff Surgical Repair

Outcome Measures

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.

  Day 0

Secondary Outcomes (7)

• Hydraulic pressure during surgery

  Day 0

• The intensity of bleeding during surgery

  Day 0

• Sedation administered to the patient during surgery

  Day 0

• Patient pain after surgery

  Day 1 to day 21

• Patient satisfaction 3 weeks after surgery

  3 weeks

Study Arms (2)

Loco regional anesthesia alone

EXPERIMENTAL

Arthroscopic rotator cuff repair performed under LRA alone

Procedure: Arthroscopic rotator cuff repair; Drug: naropeine or chirocaine (Arthroscopic rotator cuff repair under LRA)

Loco regional anesthesia associated to general anesthesia

ACTIVE COMPARATOR

Arthroscopic rotator cuff repair performed under LRA and GA

Procedure: Arthroscopic rotator cuff repair; Drug: naropeine or chirocaine (Arthroscopic rotator cuff repair under LRA associated to GA)

Interventions

Arthroscopic rotator cuff repair PROCEDURE

The operation involves systematic acromioplasty during the supra +/- infraspinatus repair and sometimes requires a tenotomy of the long biceps if it is pathological.

Loco regional anesthesia alone; Loco regional anesthesia associated to general anesthesia

naropeine or chirocaine (Arthroscopic rotator cuff repair under LRA associated to GA) DRUG

Loco 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.

Loco regional anesthesia associated to general anesthesia

naropeine or chirocaine (Arthroscopic rotator cuff repair under LRA) DRUG

Loco Regional Anesthesia is performed by injecting anesthetic (between 10 and 20 ml of naropeine or chirocaine) into the interscalene nerve block under ultrasound guidance

Loco regional anesthesia alone

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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.

You may not qualify if:

• 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
• 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.

Sponsors & Collaborators

• Elsan: lead

Study Sites (4)

Clinique Bretéché

Nantes, 44000, France

RECRUITING

CHP St Grégoire

Saint-Grégoire, 35760, France

NOT YET RECRUITING

Clinique Belledonne

Saint-Martin-d'Hères, France

RECRUITING

Hôpital privé St Claude

Saint-Quentin, France

RECRUITING

MeSH Terms

Interventions

Ropivacaine; Levobupivacaine

Intervention Hierarchy (Ancestors)

Anilides; Amides; Organic Chemicals; Aniline Compounds; Amines; Bupivacaine

Study Officials

• Laurent BAVEREL, Dr

  Clinique Bretéché ELSAN

  PRINCIPAL INVESTIGATOR

Central Study Contacts

Vincent WYART, MSc

CONTACT

0240958176; vincent.wyart@elsan.care

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: SINGLE
• Who Masked: OUTCOMES ASSESSOR
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Model Details: 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

Study Record Dates

• First Submitted: April 21, 2023
• First Posted: May 8, 2023
• Study Start: November 13, 2023
• Primary Completion: December 1, 2024
• Study Completion: July 1, 2025
• Last Updated: June 13, 2024

Record last verified: 2024-06

Data Sharing

• IPD Sharing: Will not share

Locations

FR (4)