Shoulder LesionsBISBSCNCT03743974
Analgesic Efficacy of US-Guided Interscalene Block Versus Supraclavicular Block for Ambulatory Arthroscopic Rotator Cuff Repair
A study testing arthroscopic shoulder surgery of rotary cuff (ISB) and arthroscopic shoulder surgery of rotary cuff (CSB) in people with Shoulder Lesions, run by GCS Ramsay Santé pour l'Enseignement et la Recherche.
Trial summary
Ultrasound-guided interscalene block (ISB) is the reference technique for pain control after ambulatory upper limb surgery, but supraclavicular block (SCB) is an alternative procedure. We compared the efficacy of these two techniques in patients undergoing ambulatory arthroscopic rotator cuff repair (ARCR). Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Shoulder Lesions
- What is being tested?
- arthroscopic shoulder surgery of rotary cuff (ISB) and arthroscopic shoulder surgery of rotary cuff (CSB)
- Type of treatment
- Injection or infusion, Surgery or procedure
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 108 participants
- Where
- No sites listed yet
- Study dates
- 3 Oct 2016to 2 Oct 2017
- 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
- The patients were adults undergoing ARCR by a single surgeon (NJ), under RA and general anesthesia (GA);
- Returning home on the evening of their surgery (hospital stay <12 h);
- Patients adults ;
- Patients with social health insurance ;
- Patient able to understand the objective and constrains of the study.
Who cannot join
- patients enable to return home on the evening of their surgery (for a medical or other reason);
- patients taking oral morphine derivatives before their surgery;
- patients with a contraindication for RA or in whom RA was not performed; those with a contraindication for oral morphine derivatives;
- patients who developed a complication during implementation of RA;
- patients refusing to participate in the study;
- patients whose consent was not recorded.
About this study
Official title: Analgesic Efficacy of Ultrasound-Guided Interscalene Block Versus Supraclavicular Block for Ambulatory Arthroscopic Rotator Cuff Repair: a Prospective, Randomized, Single-blind, Comparative Study
Ultrasound-guided interscalene block (ISB) is the reference technique for pain control after ambulatory upper limb surgery, but supraclavicular block (SCB) is an alternative procedure. We compared the efficacy of these two techniques in patients undergoing ambulatory arthroscopic rotator cuff repair (ARCR).
Read the detailed description
The number of patients undergoing ambulatory arthroscopic rotator cuff repair (ARCR) in our center is increasing annually. This procedure is associated with significant postoperative pain and effective analgesia is required in order to develop day-case surgery. Although continuous interscalene catheter block (ISB) is considered to be the most effective analgesic technique for ARCR, the difficulties in implementing and monitoring ISB have led to many anesthesiologists preferring single injection block, so that patients can be discharged on the same day as surgery with a satisfactory level of pain control.
ISB is frequently associated with phrenic nerve block,even with low volumes of local anesthetics. Phrenic nerve block is a concern in some ambulatory surgery patients as it may lead to respiratory complications after hospital discharge, limiting the eligibility of many patients for day surgery. Changes in spirometry variables have been associated with ISB, whatever the site of injection around the roots (anterior or posterior). Nevertheless, effective regional anesthesia (RA) is essential for this surgery, because multimodal analgesia alone is insufficient.
Several alternatives to ISB exist that are associated with a decreased prevalence of phrenic nerve paresis.6 Supraclavicular block (SCB) decreases the risk of phrenic nerve involvement, particularly when guided by ultrasound. This technique, which has been linked to a risk of pneumothorax when carried out by neurostimulation only, has now been revived and is included among the RA techniques considered to be safe in terms of respiratory risk, especially when guided by ultrasound. Many studies have demonstrated a decreased risk of phrenic paresis with ultrasound-guided SCB, even with volumes as high as 20 mL. Published studies have demonstrated that SCB is an effective alternative to ISB, and many studies have shown that ultrasound-guided SCB is a safe technique for ambulatory shoulder surgery in terms of respiratory complications. SCB is therefore a real alternative to ISB for ambulatory ARCR, but comparative studies are necessary to evaluate its analgesic efficacy after patients have been discharged from hospital, particularly in terms of their oral morphine consumption at home.
Investigators carried out a monocentric, prospective, comparative study to determine whether SCB is non-inferior to ISB in terms of post-operative analgesia in patients undergoing ambulatory ARCR. Analgesic efficacy was determined by oral morphine use and/or pain scores in patients after hospital discharge. Promotor hypothesis was that SCB would provide similar or better analgesia to ISB in patients returning home on the evening of their surgery.
- Conditions
- Shoulder Lesions
- Being tested
- arthroscopic shoulder surgery of rotary cuff (ISB), arthroscopic shoulder surgery of rotary cuff (CSB)
- Keywords
- arthroscopic shoulder surgery, interscalene block analgesia, supraclavicular block analgesia, Ambulatory surgery for rotator cuff
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
arthroscopic shoulder surgery of rotary cuff (ISB)Procedure or surgery
ISB were performed in the same manner by one of the two anesthesiologists in our team: (i) patients were monitored, after sedation with sublingual midazolam (0.1 mg/kg) + a single bolus of intravenous (IV) ketamine (0.2 mg/kg); (ii) ultrasound-guidance was carried out using a Kontron® or General Electric® ultrasound machine; (iii) neurostimulation was performed with a Stimuplex HNS® 12 set at 0.1 ms, 1 Hz and 1 mA stimulation, in sentinel mode, with the aim of securing the approach of the needle; (iv) a single perineural injection was performed with a 50 mm Vygon® needle containing a mixture of 100 mg levobupivacaine (20 mL, 0.5%) and clonidine (1 µg/kg patient) as is the local common protocol and in the absence of contraindications.
arthroscopic shoulder surgery of rotary cuff (CSB)Procedure or surgery
SCB were performed in the same manner by one of the two anesthesiologists in our team: (i) patients were monitored, after sedation with sublingual midazolam (0.1 mg/kg) + a single bolus of intravenous (IV) ketamine (0.2 mg/kg); (ii) ultrasound-guidance was carried out using a Kontron® or General Electric® ultrasound machine; (iii) neurostimulation was performed with a Stimuplex HNS® 12 set at 0.1 ms, 1 Hz and 1 mA stimulation, in sentinel mode, with the aim of securing the approach of the needle; (iv) a single perineural injection was performed with a 50 mm Vygon® needle containing a mixture of 100 mg levobupivacaine (20 mL, 0.5%) and clonidine (1 µg/kg patient) as is the local common protocol and in the absence of contraindications.
| Study group | Role | What they receive |
|---|---|---|
| Interscalene block | Active comparator | Site of injection for ISB was the C6 plexus nerve root with a posterior in-plane approach, with neurostimulation control, and ultrasound-controlled of extra-plexus injection of the mixture posterior to the C6 root Receives: Procedure: arthroscopic shoulder surgery of rotary cuff (ISB) |
| Supraclavicular block | Experimental | Site of injection for SCB was superficial and lateral to the trunks of the brachial plexus, and not directly deep inside the "corner pocket" zone, with neurostimulation control and visualization of the lung Receives: Procedure: arthroscopic shoulder surgery of rotary cuff (CSB) |
What is being measured
The primary outcome is the main question the study is designed to answer.
non-inferiority of BSC in relation to BIS on postoperative analgesic efficacy for arthroscopic outpatient shoulder rotator cuff repair surgery.
Opioid oral consumption at home within 48 hours of returning home.
Measured: 2 days
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted16 Nov 2018
- Study start3 Oct 2016
- Primary completion2 Oct 2017
- Study completion2 Oct 2017
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Shoulder LesionsStudies of the same condition, open and under way.
- More trials run by GCS Ramsay Santé pour l'Enseignement et la RechercheThe sponsor's other registered studies.
- 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
- Masking
- None (open label)
- Enrolment
- 108 participants (actual)
Sponsor and investigators
- Sponsor type
- University, hospital or other
- Collaborators
- Hôpital Privé Jean Mermoz. Service Dr Julien Cabaton
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT03743974
- Sponsor's protocol ID
- RGDS BISBSC
- Acronym
- BISBSC
- Status last verified
- Jul 2026
- First submitted
- 14 Nov 2018
- Last updated
- 16 Jul 2026
- 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 16 Jul 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Analgesic Efficacy of Ultrasound-Guided Interscalene Block Versus Supraclavicular Block for Ambulatory Arthroscopic Rotator Cuff Repair: a Prospective, Randomized, Single-blind, Comparative Study
- ClinicalTrials.gov ID
- NCT03743974
- Acronym / sponsor ID
- BISBSC / RGDS BISBSC
- Conditions
- Shoulder Lesions
- Keywords
- arthroscopic shoulder surgery, interscalene block analgesia, supraclavicular block analgesia, Ambulatory surgery for rotator cuff
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 108 participants (actual)
- Lead sponsor
- GCS Ramsay Santé pour l'Enseignement et la RechercheUniversity, hospital or other
- Collaborators
- Hôpital Privé Jean Mermoz. Service Dr Julien Cabaton
- Study start
- 3 Oct 2016 (actual)
- Primary completion
- 2 Oct 2017 (actual)
- Study completion
- 2 Oct 2017 (actual)
- First posted
- 16 Nov 2018 (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.
Ultrasound-guided interscalene block (ISB) is the reference technique for pain control after ambulatory upper limb surgery, but supraclavicular block (SCB) is an alternative procedure. We compared the efficacy of these two techniques in patients undergoing ambulatory arthroscopic rotator cuff repair (ARCR).
Detailed description
The number of patients undergoing ambulatory arthroscopic rotator cuff repair (ARCR) in our center is increasing annually. This procedure is associated with significant postoperative pain and effective analgesia is required in order to develop day-case surgery. Although continuous interscalene catheter block (ISB) is considered to be the most effective analgesic technique for ARCR, the difficulties in implementing and monitoring ISB have led to many anesthesiologists preferring single injection block, so that patients can be discharged on the same day as surgery with a satisfactory level of pain control.
ISB is frequently associated with phrenic nerve block,even with low volumes of local anesthetics. Phrenic nerve block is a concern in some ambulatory surgery patients as it may lead to respiratory complications after hospital discharge, limiting the eligibility of many patients for day surgery. Changes in spirometry variables have been associated with ISB, whatever the site of injection around the roots (anterior or posterior). Nevertheless, effective regional anesthesia (RA) is essential for this surgery, because multimodal analgesia alone is insufficient.
Several alternatives to ISB exist that are associated with a decreased prevalence of phrenic nerve paresis.6 Supraclavicular block (SCB) decreases the risk of phrenic nerve involvement, particularly when guided by ultrasound. This technique, which has been linked to a risk of pneumothorax when carried out by neurostimulation only, has now been revived and is included among the RA techniques considered to be safe in terms of respiratory risk, especially when guided by ultrasound. Many studies have demonstrated a decreased risk of phrenic paresis with ultrasound-guided SCB, even with volumes as high as 20 mL. Published studies have demonstrated that SCB is an effective alternative to ISB, and many studies have shown that ultrasound-guided SCB is a safe technique for ambulatory shoulder surgery in terms of respiratory complications. SCB is therefore a real alternative to ISB for ambulatory ARCR, but comparative studies are necessary to evaluate its analgesic efficacy after patients have been discharged from hospital, particularly in terms of their oral morphine consumption at home.
Investigators carried out a monocentric, prospective, comparative study to determine whether SCB is non-inferior to ISB in terms of post-operative analgesia in patients undergoing ambulatory ARCR. Analgesic efficacy was determined by oral morphine use and/or pain scores in patients after hospital discharge. Promotor hypothesis was that SCB would provide similar or better analgesia to ISB in patients returning home on the evening of their surgery.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Interscalene block | Active comparator | Procedure: arthroscopic shoulder surgery of rotary cuff (ISB)Site of injection for ISB was the C6 plexus nerve root with a posterior in-plane approach, with neurostimulation control, and ultrasound-controlled of extra-plexus injection of the mixture posterior to the C6 root |
| Supraclavicular block | Experimental | Procedure: arthroscopic shoulder surgery of rotary cuff (CSB)Site of injection for SCB was superficial and lateral to the trunks of the brachial plexus, and not directly deep inside the "corner pocket" zone, with neurostimulation control and visualization of the lung |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (5 listed)
- The patients were adults undergoing ARCR by a single surgeon (NJ), under RA and general anesthesia (GA);
- Returning home on the evening of their surgery (hospital stay <12 h);
- Patients adults ;
- Patients with social health insurance ;
- Patient able to understand the objective and constrains of the study.
Key exclusion criteria (6 listed)
- patients enable to return home on the evening of their surgery (for a medical or other reason);
- patients taking oral morphine derivatives before their surgery;
- patients with a contraindication for RA or in whom RA was not performed; those with a contraindication for oral morphine derivatives;
- patients who developed a complication during implementation of RA;
- patients refusing to participate in the study;
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 shoulder surgery of rotary cuff (ISB)ISB were performed in the same manner by one of the two anesthesiologists in our team: (i) patients were monitored, after sedation with sublingual midazolam (0.1 mg/kg) + a single bolus of intravenous (IV) ketamine (0.2 mg/kg); (ii) ultrasound-guidance was carried out using a Kontron® or General Electric® ultrasound machine; (iii) neurostimulation was performed with a Stimuplex HNS® 12 set at 0.1 ms, 1 Hz and 1 mA stimulation, in sentinel mode, with the aim of securing the approach of the needle; (iv) a single perineural injection was performed with a 50 mm Vygon® needle containing a mixture of 100 mg levobupivacaine (20 mL, 0.5%) and clonidine (1 µg/kg patient) as is the local common protocol and in the absence of contraindications. | Procedure or surgery | Interscalene block |
| arthroscopic shoulder surgery of rotary cuff (CSB)SCB were performed in the same manner by one of the two anesthesiologists in our team: (i) patients were monitored, after sedation with sublingual midazolam (0.1 mg/kg) + a single bolus of intravenous (IV) ketamine (0.2 mg/kg); (ii) ultrasound-guidance was carried out using a Kontron® or General Electric® ultrasound machine; (iii) neurostimulation was performed with a Stimuplex HNS® 12 set at 0.1 ms, 1 Hz and 1 mA stimulation, in sentinel mode, with the aim of securing the approach of the needle; (iv) a single perineural injection was performed with a 50 mm Vygon® needle containing a mixture of 100 mg levobupivacaine (20 mL, 0.5%) and clonidine (1 µg/kg patient) as is the local common protocol and in the absence of contraindications. | Procedure or surgery | Supraclavicular block |
Primary outcome
non-inferiority of BSC in relation to BIS on postoperative analgesic efficacy for arthroscopic outpatient shoulder rotator cuff repair surgery.
Time frame: 2 days
Opioid oral consumption at home within 48 hours of returning home.
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 16 Jul 2026.
- Individual participant dataSharing planned: No
Related trials for Shoulder Lesions
Active, not recruitingPhase 2
Influence of an Anti-osteoporotic Drug on Healing After Surgical Repair of Chronic Rotator Cuff Lesions of the Shoulder
Orthopedics, Traumatology
Active, not recruitingObservational study
Outcomes of Arthroscopic Dynamic Anterior Stabilization With and Without Remplissage
Anterior Shoulder Instability
Recruiting
Arthroscopic Rotator Cuff Repair With Long Head of Biceps Transposition and Acellular Dermal Matrix Augmentation for Large to Massive Incompletely Repairable Rotator Cuff Tears
Rotator Cuff Tears, Rotator Cuff Injuries
Recruiting
Comparison of Surgical Techniques for Anterior Shoulder Instability
Surgeons, Shoulder Instability
RecruitingObservational study
Post-Market Clinical Follow-up (PMCF) Study of the Pitch-Patch for the Augmentation or Reinforcement of the Rotator Cuff
Rotator Cuff Tear, Rotator Cuff Tears
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.
The record lists no contact. Use the official record to reach the sponsor.
Questions about this trial
What is this clinical trial studying?
A study testing arthroscopic shoulder surgery of rotary cuff (ISB) and arthroscopic shoulder surgery of rotary cuff (CSB) in people with Shoulder Lesions, run by GCS Ramsay Santé pour l'Enseignement et la Recherche.
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 5 inclusion and 6 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: finished, as of the sponsor's last update on 16 Jul 2026. Status can change between updates, so confirm with the study contact before making plans.
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?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
non-inferiority of BSC in relation to BIS on postoperative analgesic efficacy for arthroscopic outpatient shoulder rotator cuff repair surgery. (time frame: 2 days). 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 16 Jul 2026.