Rotator Cuff TearPhase 4NCT02007057
Effectiveness of Suprascapular Nerve Block in Arthroscopic Shoulder Surgery
A Phase 4 study testing Suprascapular nerve block and Interscalene nerve block in people with Rotator Cuff Tear and Pain, run by Hospital Ambroise Paré Paris at 1 site in France.
Trial summary
Most arthroscopic surgeries of the shoulder are currently performed as an outpatient. The postoperative analgesia should be optimal. General anesthesia allows for any arthroscopic surgery but does not provide a satisfactory postoperative analgesia . Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Rotator Cuff Tear, Pain
- What is being tested?
- Suprascapular nerve block and Interscalene nerve block
- Type of treatment
- Injection or infusion, Surgery or procedure
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 74 participants
- Where
- 1 siteFrance
- Study dates
- Nov 2013to Nov 2014
- Phase
- Phase 4
- 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
- Aged over 18 years
- Arthroscopic repair of infra and / or supraspinatus tendon of the rotator cuff with or without associated procedure on the biceps, the acromion-clavicular joint or acromion
- Informed consent
Who cannot join
- Allergy to local anesthetics (ropivacaine, bupivacaine, xylocaine)
- Previous surgery on the involved shoulder
- Severe or morbid obesity (BMI> 35)
- Psychiatric disorders (impossible self-assessment of the pain)
- Patient unfit physically, mentally or legally to give informed consent
- Patient refusal
- Pregnant or lactating women
Trial locations and contacts
1 site in 1 country.
About this study
Official title: Prospective Randomized Comparative Study of the Effectiveness of Suprascapular Nerve Block in Arthroscopic Shoulder Surgery
Most arthroscopic surgeries of the shoulder are currently performed as an outpatient. The postoperative analgesia should be optimal. General anesthesia allows for any arthroscopic surgery but does not provide a satisfactory postoperative analgesia . The locoregional anesthesia is recommended and includes several techniques: the interscalene nerve block, the suprascapular nerve block, intra-articular injection of local anesthetic and subacromial infiltration. The interscalene nerve block is currently the gold standard for anesthesia and postoperative analgesia for arthroscopic shoulder surgery with a success rate above 80% . However it must be carried out by teams experienced in the locoregional anesthesia because it is operator -dependent. The suprascapular nerve block is a simple technique that can be performed by the surgeon after surgery , effective in arthroscopic shoulder surgery , less invasive than the interscalene nerve block and exposing the patient to fewer complications. However, his interest was not assessed in the repair of tendons of the rotator cuff. The main hypothesis of this study is that the suprascapular nerve block is as effective as the interscalene nerve block in the prevention of early postoperative pain after arthroscopic repair of the infra and / or the supraspinatus rotator cuff tendons, without increasing the analgesic consumption while reducing the risk of complications related to regional anesthesia.
- Conditions
- Rotator Cuff Tear, Pain
- Being tested
- Suprascapular nerve block, Interscalene nerve block
- Keywords
- Suprascapular nerve block, Interscalene nerve block
- Medical subject headings
- Rotator Cuff Injuries, Pain
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Suprascapular nerve blockProcedure or surgery
Interscalene nerve blockProcedure or surgery
| Study group | Role | What they receive |
|---|---|---|
| Interscalene nerve block | Active comparator | Interscalene block is performed preoperatively with ultrasound guidance and neurostimulation 0.8 milliampere. The block is performed using "in-plane" approach with a needle of 50 mm for a neurostimulation. During the injection, it is verified that the diffusion extends to the anterior and posterior space. If the posterior distribution is limited, the needle is remobilized to obtain an overall diffusion: a bolus of 20 mL of ropivacaine 0.75% is made by the anesthetist. The effectiveness of the nerve block is checked before the start of surgery. Receives: Procedure: Interscalene nerve block |
| Suprascapular nerve block | Experimental | The suprascapular block is performed at the end of surgery when the incisions are closed but before the removal of the surgical drapes. The material used is a compound of a 10 cc syringe sterile equipment, a green intramuscular needle (14 gauge) and a bulb 10 cc of 0.75% Ropivacaine. The injection of 10 cc is realized by the technical princeps Receives: Procedure: Suprascapular nerve block |
What is being measured
The primary outcome is the main question the study is designed to answer.
Self-assessment of the mean shoulder pain
Measured: Visual analog scale (VAS) during 2 days postoperatively
Secondary outcomes (2)
Self assessment of shoulder pain
Measured: VAS twice daily during the first postoperative week
Complications of locoregional anesthesia
Measured: Yes or No during the first 24 hours
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted10 Dec 2013 (estimated)
- Study startNov 2013
- Primary completionNov 2014
- Study completionNov 2014
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Rotator Cuff TearStudies 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 4
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Double blind
- Who is masked
- Participant, Outcomes assessor
- Enrolment
- 74 participants (actual)
Sponsor and investigators
- Lead sponsor
- Hospital Ambroise Paré Paris
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Shahnaz Klouche, MD, Hospital Ambroise Paré Paris
- Investigators
- Philippe Hardy, MD, PhD, Principal investigator, Ambroise Pare Hospital
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT02007057
- Sponsor's protocol ID
- APR112013
- Status last verified
- Feb 2015
- First submitted
- 29 Nov 2013
- Last updated
- 9 Feb 2015
- Results posted
- No
- Data monitoring committee
- Yes
Study at a glance
From the registry record, last updated by the sponsor on 9 Feb 2015. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Prospective Randomized Comparative Study of the Effectiveness of Suprascapular Nerve Block in Arthroscopic Shoulder Surgery
- ClinicalTrials.gov ID
- NCT02007057
- Acronym / sponsor ID
- APR112013
- Conditions
- Rotator Cuff Tear, Pain
- Keywords
- Suprascapular nerve block, Interscalene nerve block
- Phase
- Phase 4
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 74 participants (actual)
- Lead sponsor
- Hospital Ambroise Paré ParisUniversity, hospital or other
- Study start
- Nov 2013
- Primary completion
- Nov 2014 (actual)
- Study completion
- Nov 2014 (actual)
- First posted
- 10 Dec 2013 (estimated)
- 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.
Most arthroscopic surgeries of the shoulder are currently performed as an outpatient. The postoperative analgesia should be optimal. General anesthesia allows for any arthroscopic surgery but does not provide a satisfactory postoperative analgesia . The locoregional anesthesia is recommended and includes several techniques: the interscalene nerve block, the suprascapular nerve block, intra-articular injection of local anesthetic and subacromial infiltration. The interscalene nerve block is currently the gold standard for anesthesia and postoperative analgesia for arthroscopic shoulder surgery with a success rate above 80% . However it must be carried out by teams experienced in the locoregional anesthesia because it is operator -dependent. The suprascapular nerve block is a simple technique that can be performed by the surgeon after surgery , effective in arthroscopic shoulder surgery , less invasive than the interscalene nerve block and exposing the patient to fewer complications. However, his interest was not assessed in the repair of tendons of the rotator cuff. The main hypothesis of this study is that the suprascapular nerve block is as effective as the interscalene nerve block in the prevention of early postoperative pain after arthroscopic repair of the infra and / or the supraspinatus rotator cuff tendons, without increasing the analgesic consumption while reducing the risk of complications related to regional anesthesia.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Double blind (participant, outcomes assessor)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Interscalene nerve block | Active comparator | Procedure: Interscalene nerve blockInterscalene block is performed preoperatively with ultrasound guidance and neurostimulation 0.8 milliampere. The block is performed using "in-plane" approach with a needle of 50 mm for a neurostimulation. During the injection, it is verified that the diffusion extends to the anterior and posterior space. If the posterior distribution is limited, the needle is remobilized to obtain an overall diffusion: a bolus of 20 mL of ropivacaine 0.75% is made by the anesthetist. The effectiveness of the nerve block is checked before the start of surgery. |
| Suprascapular nerve block | Experimental | Procedure: Suprascapular nerve blockThe suprascapular block is performed at the end of surgery when the incisions are closed but before the removal of the surgical drapes. The material used is a compound of a 10 cc syringe sterile equipment, a green intramuscular needle (14 gauge) and a bulb 10 cc of 0.75% Ropivacaine. The injection of 10 cc is realized by the technical princeps |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (3 listed)
- Aged over 18 years
- Arthroscopic repair of infra and / or supraspinatus tendon of the rotator cuff with or without associated procedure on the biceps, the acromion-clavicular joint or acromion
- Informed consent
Key exclusion criteria (7 listed)
- Allergy to local anesthetics (ropivacaine, bupivacaine, xylocaine)
- Previous surgery on the involved shoulder
- Severe or morbid obesity (BMI> 35)
- Psychiatric disorders (impossible self-assessment of the pain)
- Patient unfit physically, mentally or legally to give informed consent
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 |
|---|---|---|
| Suprascapular nerve block | Procedure or surgery | Suprascapular nerve block |
| Interscalene nerve block | Procedure or surgery | Interscalene nerve block |
Primary outcome
Self-assessment of the mean shoulder pain
Time frame: Visual analog scale (VAS) during 2 days postoperatively
2 secondary outcomes
Self assessment of shoulder pain
Time frame: VAS twice daily during the first postoperative week
Complications of locoregional anesthesia
Time frame: Yes or No during the first 24 hours
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 9 Feb 2015.
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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.
Philippe Hardy, MD, PhD principal investigator
Ambroise Pare Hospital
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 4 study testing Suprascapular nerve block and Interscalene nerve block in people with Rotator Cuff Tear and Pain, run by Hospital Ambroise Paré Paris at 1 site 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 3 inclusion and 7 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 9 Feb 2015. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site 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.
What does this phase mean?
Phase 4 studies take place after a treatment is approved, to learn more about its long-term benefits and risks in everyday use.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
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?
Self-assessment of the mean shoulder pain (time frame: Visual analog scale (VAS) during 2 days postoperatively). 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 9 Feb 2015; AzTrials last refreshed its copy on 6 Nov 2026.