Shoulder Cuff Surgical RepairAGORANCT05848375
Rotator Cuff Repair Under Isolated Loco-regional Anesthesia
A study testing Arthroscopic rotator cuff repair, naropeine or chirocaine (Arthroscopic rotator cuff repair under LRA associated to GA) and naropeine or chirocaine (Arthroscopic rotator cuff repair under LRA) in people with Shoulder Cuff Surgical Repair, run by Elsan at 4 sites in France.
Trial 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. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Shoulder Cuff Surgical Repair
- What is being tested?
- Arthroscopic rotator cuff repair, naropeine or chirocaine (Arthroscopic rotator cuff repair under LRA associated to GA) and naropeine or chirocaine (Arthroscopic rotator cuff repair under LRA)
- Type of treatment
- Injection or infusion, Surgery or procedure
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 80 participants
- Where
- 4 sitesFrance
- Study dates
- 13 Nov 2023to Jul 2025
- Phase
- Interventional
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- 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).
Who cannot join
- 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
Show all 14Show fewer
- 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.
Trial locations and contacts
4 sites in 1 country.
France4 sites, 4 recruiting
- Recruiting
Clinique Bretéché
Nantes, 44000
Laurent BAVEREL, Dr, 06 74 10 60 39, l.baverel@gmail.com
- Not yet recruiting
CHP St Grégoire
Saint-Grégoire, 35760
Philippe COLLIN, Dr, 02 99 23 33 27, docphcollin@gmail.com
- Recruiting
Clinique Belledonne
Saint-Martin-d'Hères
Rémi CHARVET
Rémi CHARVET, Dr
- Recruiting
Hôpital privé St Claude
Saint-Quentin
Didier THEVENIN
Didier THEVENIN, Dr
About this study
Official title: Rotator Cuff Repair Under Isolated Loco-regional Anesthesia Versus General Anesthesia Combined With Loco-regional Anesthesia: Randomized Controlled Trial of Superiority.
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.
Read the 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
- Conditions
- Shoulder Cuff Surgical Repair
- Being tested
- 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)
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Arthroscopic rotator cuff repairProcedure or surgery
The 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)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.
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
| Study group | Role | What they receive |
|---|---|---|
| Loco regional anesthesia alone | Experimental | Arthroscopic rotator cuff repair performed under LRA alone Receives: 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 Receives: Procedure: Arthroscopic rotator cuff repair; Drug: naropeine or chirocaine (Arthroscopic rotator cuff repair under LRA associated to GA) |
What is being measured
The primary outcome is the main question the study is designed to answer.
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.
Measured: Day 0
Secondary outcomes (7)
Hydraulic pressure during surgery
The difference in pressure administered by the arthrpomp between the beginning and the end of the surgery
Measured: Day 0
The intensity of bleeding during surgery
The intensity of bleeding during surgery, assessed by the number of washes performed
Measured: Day 0
Sedation administered to the patient during surgery
Sedation assessed by the type of sedation administered to the patient: no sedation, hypnotic sedation, morphine sedation
Measured: Day 0
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.
Measured: Day 1 to day 21
Patient satisfaction 3 weeks after surgery
Patient satisfaction on the surgery will be measured by a 4 point Likert scale and positive and negative points will be collected in comments
Measured: 3 weeks
Adverse events between patients operated on LRA alone and patients on LRA and GA.
The number and type of adverse events noted during the procedure and in the 6 months post-operation.
Measured: Day 0 to 6 months
Medication taken for pain between these same groups of patients in the 21 days following surgery.
The patient's daily consumption of painkillers will be recorded in a patient diary for 21 days after the intervention
Measured: Day 1 to day 21
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted8 May 2023
- Study start13 Nov 2023
- Primary completionDec 2024 (estimated)
- Study completionJul 2025 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Shoulder Cuff Surgical RepairStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- 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
- Masking
- Single blind
- Who is masked
- Outcomes assessor
- Enrolment
- 80 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Elsan
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
- Investigators
- Laurent BAVEREL, Dr, Principal investigator, Clinique Bretéché ELSAN
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT05848375
- Sponsor's protocol ID
- 2023-A00499-36
- Acronym
- AGORA
- Status last verified
- Jun 2024
- First submitted
- 21 Apr 2023
- Last updated
- 13 Jun 2024
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 13 Jun 2024. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Rotator Cuff Repair Under Isolated Loco-regional Anesthesia Versus General Anesthesia Combined With Loco-regional Anesthesia: Randomized Controlled Trial of Superiority.
- ClinicalTrials.gov ID
- NCT05848375
- Acronym / sponsor ID
- AGORA / 2023-A00499-36
- Conditions
- Shoulder Cuff Surgical Repair
- Study type
- Interventional
- Recruitment status
- Unknown status
- Enrolment
- 80 participants (estimated)
- Lead sponsor
- ElsanUniversity, hospital or other
- Study start
- 13 Nov 2023 (actual)
- Primary completion
- Dec 2024 (estimated)
- Study completion
- Jul 2025 (estimated)
- First posted
- 8 May 2023 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind (outcomes assessor)
- Number of arms
- 2
- 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
| Arm | Type | Receives |
|---|---|---|
| Loco regional anesthesia alone | Experimental | Procedure: Arthroscopic rotator cuff repair, Drug: naropeine or chirocaine (Arthroscopic rotator cuff repair under LRA)Arthroscopic rotator cuff repair performed under LRA alone |
| Loco regional anesthesia associated to general anesthesia | Active comparator | Procedure: Arthroscopic rotator cuff repair, Drug: naropeine or chirocaine (Arthroscopic rotator cuff repair under LRA associated to GA)Arthroscopic rotator cuff repair performed under LRA and GA |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (4 listed)
- 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).
Key exclusion criteria (14 listed)
- 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
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Arthroscopic rotator cuff repairThe operation involves systematic acromioplasty during the supra +/- infraspinatus repair and sometimes requires a tenotomy of the long biceps if it is pathological. | Procedure or surgery | Loco regional anesthesia alone, Loco regional anesthesia associated to general anesthesia |
| naropeine or chirocaine (Arthroscopic rotator cuff repair under LRA associated to GA)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. | Drug | Loco regional anesthesia associated to general anesthesia |
| naropeine or chirocaine (Arthroscopic rotator cuff repair under LRA)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 | Drug | Loco regional anesthesia alone |
Primary outcome
compare systolic blood pressure (SBP) measured during surgery between patients operated for rotator cuff repair under LRA alone and those under LRA and GA.
Time frame: Day 0
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.
7 secondary outcomes
Hydraulic pressure during surgery
Time frame: Day 0
The intensity of bleeding during surgery
Time frame: Day 0
Sedation administered to the patient during surgery
Time frame: Day 0
Patient pain after surgery
Time frame: Day 1 to day 21
Patient satisfaction 3 weeks after surgery
Time frame: 3 weeks
Adverse events between patients operated on LRA alone and patients on LRA and GA.
Time frame: Day 0 to 6 months
Medication taken for pain between these same groups of patients in the 21 days following surgery.
Time frame: Day 1 to day 21
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 13 Jun 2024.
- Individual participant dataSharing planned: No
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Laurent BAVEREL, Dr principal investigator
Clinique Bretéché ELSAN
4 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Arthroscopic rotator cuff repair, naropeine or chirocaine (Arthroscopic rotator cuff repair under LRA associated to GA) and naropeine or chirocaine (Arthroscopic rotator cuff repair under LRA) in people with Shoulder Cuff Surgical Repair, run by Elsan at 4 sites in France.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 4 inclusion and 14 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: status not confirmed, as of the sponsor's last update on 13 Jun 2024. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 4 sites in France. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
Contact Vincent WYART, MSc (0240958176, vincent.wyart@elsan.care), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome 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. (time frame: Day 0). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 13 Jun 2024.