Shoulder PainNCT04364542
Suprascapular Nerve Block Efficacy for Shoulder Surgery
A study testing Suprascapular nerve block, Interscalene Nerve Block and Arthroscopic rotator cuff repair in people with Shoulder Pain and Postoperative Pain, run by Ivan Simionato at 1 site in Brazil.
Trial summary
This study evaluates the analgesia induced by suprascapular nerve block in comparison to interscalene nerve block in arthroscopic rotator cuff repairs. The experimental and the control group will receive the suprascapular nerve block and interscalene nerve block, respectively. Read more about this study
- Who is it for?
- Ages 18 to 80 years
- Conditions the study is for
- Shoulder Pain, Postoperative Pain, Rotator Cuff Tears
- What is being tested?
- Suprascapular nerve block, Interscalene Nerve Block and Arthroscopic rotator cuff repair
- Type of treatment
- Surgery or procedure
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 98 participants
- Where
- 1 siteBrazil
- Study dates
- 10 May 2020to 30 Aug 2021
- 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 to 80 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Age between 18 and 80 years old
- Confirmed rotator cuff tear by magnetic resonance imaging
Who cannot join
- Irreparable cuff tears (retracted lesions to the glenoid rim and/or fourth grade fatty infiltration)
- Partial repair of cuff tears (immobile lesions)
- Rheumatic diseases
- Neck-related shoulder pain
- Glenohumeral instability or osteoarthritis
Trial locations and contacts
1 site in 1 country.
Brazil1 site
Irmandade Santa Casa de Misericordia de Porto Alegre
Porto Alegre, Rio Grande do Sul, 90035072
Rodrigo PG Barreto, PhD, +5551985861181, rodrigopyy@gmail.com
About this study
Official title: Suprascapular Nerve Block Efficacy for Arthroscopic Rotator Cuff Repair: a Randomized Clinical Trial
This study evaluates the analgesia induced by suprascapular nerve block in comparison to interscalene nerve block in arthroscopic rotator cuff repairs. The experimental and the control group will receive the suprascapular nerve block and interscalene nerve block, respectively.
Read the detailed description
Peripheral nerve blocks are widely used for postsurgical analgesia. Interscalene nerve block provides a total brachial plexus motor and sensitive blockade while the suprascapular nerve block produces only a specific peripheral blockade.
The interscalene nerve block is the most frequently used anesthesia technique and requires a longer learning curve. Complications related to this technique may be more severe and frequent in comparison to other regional anesthesia techniques.
The suprascapular nerve block yields less adverse effects, discomfort and rebound effect as this technique does not completely block the upper limb motor function.
- Being tested
- Suprascapular nerve block, Interscalene Nerve Block, Arthroscopic rotator cuff repair
- Keywords
- Shoulder surgery, Pain, Brachial plexus blockage, Anesthesia, Interscalene blockage, Opioid
- Medical subject headings
- Shoulder Pain, Pain, Postoperative, 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
The patient lies supine in beach chair position with surgical drapes on. The anatomical landmarks are outlined and the infiltration spot is identified. The block is performed with 10 ml ropivacaine 0.75%.
Interscalene Nerve BlockProcedure or surgery
Also called Interscalene Brachial Plexus Nerve Blockade
The patient lies supine position with the head turned to the contralateral side to the block. A linear high-frequency ultrasound probe is used for identifying the roots of supraclavicular brachial plexus using the traceback technique. The block is performed with 15 ml ropivacaine 0.5%.
Arthroscopic rotator cuff repairProcedure or surgery
Conventional arthroscopic rotator cuff repair.
| Study group | Role | What they receive |
|---|---|---|
| Suprascapular nerve block (SSNB) | Experimental | Single shot using the blind block technique with 10 ml 0.75% ropivacaine and arthroscopic portals infiltration with 5 ml 0.75% diluted in 15 ml of distilled water. Receives: Procedure: Suprascapular nerve block; Procedure: Arthroscopic rotator cuff repair |
| Interscalene Nerve Block (ISB) | Active comparator | Single shot using US-guided interscalene brachial plexus block with 15 ml 0.5% ropivacaine and arthroscopic portals infiltration with 5 ml 0.75% diluted in 15 ml of distilled water. Receives: Procedure: Interscalene Nerve Block; Procedure: Arthroscopic rotator cuff repair |
What is being measured
The primary outcome is the main question the study is designed to answer.
Pain intensity: Numeric Pain Rating Scale
Numeric Pain Rating Scale - no pain (0), unbearable pain (10)
Measured: 1 hour after surgery
Pain intensity: Numeric Pain Rating Scale
Numeric Pain Rating Scale - no pain (0), unbearable pain (10)
Measured: 24 hours after surgery
Pain intensity: Numeric Pain Rating Scale
Numeric Pain Rating Scale - no pain (0), unbearable pain (10)
Measured: 48 hours after surgery
Pain intensity: Numeric Pain Rating Scale
Numeric Pain Rating Scale - no pain (0), unbearable pain (10)
Measured: 72 hours after surgery
Secondary outcomes (1)
Opiate Consumption
Total amount of narcotics consumed during the postoperative period measured in morphine equivalents (OME).
Measured: Postoperative hours 1-72
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted28 Apr 2020
- Study start10 May 2020 (estimated)
- Primary completion30 Jun 2021 (estimated)
- Study completion30 Aug 2021 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (7)Papers the sponsor has linked to this study.
- Other trials for Shoulder PainStudies 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
- 2 groups of patients. Randomization into groups SSNB or ISB as per randomization list, for a total of 98 patients
- Masking
- Triple blind
- Who is masked
- Participant, Investigator, Outcomes assessor
- Enrolment
- 98 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Ivan Simionato
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor-investigator, Ivan Simionato, Shoulder Surgery Group, Santa Casa de Porto Alegre
- Investigators
- Marcelo F Silva, PhD, Principal investigator, Federal University of Health Science of Porto Alegre
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT04364542
- Sponsor's protocol ID
- ShoulderSurgeryGroupSCPA
- Status last verified
- Apr 2020
- First submitted
- 11 Mar 2020
- Last updated
- 28 Apr 2020
- Results posted
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Publications
Mitchell C, Adebajo A, Hay E, Carr A. Shoulder pain: diagnosis and management in primary care. BMJ. 2005 Nov 12;331(7525):1124-8. doi: 10.1136/bmj.331.7525.1124. No abstract available.
PubMed 16282408Lindberg MF, Grov EK, Gay CL, Rustoen T, Granheim TI, Amlie E, Lerdal A. Pain characteristics and self-rated health after elective orthopaedic surgery - a cross-sectional survey. J Clin Nurs. 2013 May;22(9-10):1242-53. doi: 10.1111/jocn.12149. Epub 2013 Mar 29.
PubMed 23551432Desai N. Postoperative analgesia for shoulder surgery. Br J Hosp Med (Lond). 2017 Sep 2;78(9):511-515. doi: 10.12968/hmed.2017.78.9.511.
PubMed 28898151Hussain N, Goldar G, Ragina N, Banfield L, Laffey JG, Abdallah FW. Suprascapular and Interscalene Nerve Block for Shoulder Surgery: A Systematic Review and Meta-analysis. Anesthesiology. 2017 Dec;127(6):998-1013. doi: 10.1097/ALN.0000000000001894.
PubMed 28968280Vandepitte C, Gautier P, Xu D, Salviz EA, Hadzic A. Effective volume of ropivacaine 0.75% through a catheter required for interscalene brachial plexus blockade. Anesthesiology. 2013 Apr;118(4):863-7. doi: 10.1097/ALN.0b013e3182850dc7.
PubMed 23353796Lee JJ, Kim DY, Hwang JT, Lee SS, Hwang SM, Kim GH, Jo YG. Effect of ultrasonographically guided axillary nerve block combined with suprascapular nerve block in arthroscopic rotator cuff repair: a randomized controlled trial. Arthroscopy. 2014 Aug;30(8):906-14. doi: 10.1016/j.arthro.2014.03.014. Epub 2014 May 29.
PubMed 24880194Toma O, Persoons B, Pogatzki-Zahn E, Van de Velde M, Joshi GP; PROSPECT Working Group collaborators. PROSPECT guideline for rotator cuff repair surgery: systematic review and procedure-specific postoperative pain management recommendations. Anaesthesia. 2019 Oct;74(10):1320-1331. doi: 10.1111/anae.14796. Epub 2019 Aug 7.
PubMed 31392721
Study at a glance
From the registry record, last updated by the sponsor on 28 Apr 2020. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Suprascapular Nerve Block Efficacy for Arthroscopic Rotator Cuff Repair: a Randomized Clinical Trial
- ClinicalTrials.gov ID
- NCT04364542
- Acronym / sponsor ID
- ShoulderSurgeryGroupSCPA
- Keywords
- Shoulder surgery, Pain, Brachial plexus blockage, Anesthesia, Interscalene blockage, Opioid
- Study type
- Interventional
- Recruitment status
- Unknown status
- Enrolment
- 98 participants (estimated)
- Lead sponsor
- Ivan SimionatoUniversity, hospital or other
- Study start
- 10 May 2020 (estimated)
- Primary completion
- 30 Jun 2021 (estimated)
- Study completion
- 30 Aug 2021 (estimated)
- First posted
- 28 Apr 2020 (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.
This study evaluates the analgesia induced by suprascapular nerve block in comparison to interscalene nerve block in arthroscopic rotator cuff repairs. The experimental and the control group will receive the suprascapular nerve block and interscalene nerve block, respectively.
Detailed description
Peripheral nerve blocks are widely used for postsurgical analgesia. Interscalene nerve block provides a total brachial plexus motor and sensitive blockade while the suprascapular nerve block produces only a specific peripheral blockade.
The interscalene nerve block is the most frequently used anesthesia technique and requires a longer learning curve. Complications related to this technique may be more severe and frequent in comparison to other regional anesthesia techniques.
The suprascapular nerve block yields less adverse effects, discomfort and rebound effect as this technique does not completely block the upper limb motor function.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Triple blind (participant, investigator, outcomes assessor)
- Number of arms
- 2
- Model description
- 2 groups of patients. Randomization into groups SSNB or ISB as per randomization list, for a total of 98 patients
| Arm | Type | Receives |
|---|---|---|
| Suprascapular nerve block (SSNB) | Experimental | Procedure: Suprascapular nerve block, Procedure: Arthroscopic rotator cuff repairSingle shot using the blind block technique with 10 ml 0.75% ropivacaine and arthroscopic portals infiltration with 5 ml 0.75% diluted in 15 ml of distilled water. |
| Interscalene Nerve Block (ISB) | Active comparator | Procedure: Interscalene Nerve Block, Procedure: Arthroscopic rotator cuff repairSingle shot using US-guided interscalene brachial plexus block with 15 ml 0.5% ropivacaine and arthroscopic portals infiltration with 5 ml 0.75% diluted in 15 ml of distilled water. |
Who may qualify
- Ages
- 18 to 80 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (2 listed)
- Age between 18 and 80 years old
- Confirmed rotator cuff tear by magnetic resonance imaging
Key exclusion criteria (5 listed)
- Irreparable cuff tears (retracted lesions to the glenoid rim and/or fourth grade fatty infiltration)
- Partial repair of cuff tears (immobile lesions)
- Rheumatic diseases
- Neck-related shoulder pain
- Glenohumeral instability or osteoarthritis
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 blockThe patient lies supine in beach chair position with surgical drapes on. The anatomical landmarks are outlined and the infiltration spot is identified. The block is performed with 10 ml ropivacaine 0.75%. | Procedure or surgery | Suprascapular nerve block (SSNB) |
| Interscalene Nerve BlockAlso: Interscalene Brachial Plexus Nerve BlockadeThe patient lies supine position with the head turned to the contralateral side to the block. A linear high-frequency ultrasound probe is used for identifying the roots of supraclavicular brachial plexus using the traceback technique. The block is performed with 15 ml ropivacaine 0.5%. | Procedure or surgery | Interscalene Nerve Block (ISB) |
| Arthroscopic rotator cuff repairConventional arthroscopic rotator cuff repair. | Procedure or surgery | Interscalene Nerve Block (ISB), Suprascapular nerve block (SSNB) |
Primary outcome
Pain intensity: Numeric Pain Rating Scale
Time frame: 1 hour after surgery
Numeric Pain Rating Scale - no pain (0), unbearable pain (10)
Pain intensity: Numeric Pain Rating Scale
Time frame: 24 hours after surgery
Numeric Pain Rating Scale - no pain (0), unbearable pain (10)
Pain intensity: Numeric Pain Rating Scale
Time frame: 48 hours after surgery
Numeric Pain Rating Scale - no pain (0), unbearable pain (10)
Pain intensity: Numeric Pain Rating Scale
Time frame: 72 hours after surgery
Numeric Pain Rating Scale - no pain (0), unbearable pain (10)
1 secondary outcome
Opiate Consumption
Time frame: Postoperative hours 1-72
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 28 Apr 2020.
- Background: PubMed 16282408Mitchell C, Adebajo A, Hay E, Carr A. Shoulder pain: diagnosis and management in primary care. BMJ. 2005 Nov 12;331(7525):1124-8. doi: 10.1136/bmj.331.7525.1124. No abstract available.
- Background: PubMed 23551432Lindberg MF, Grov EK, Gay CL, Rustoen T, Granheim TI, Amlie E, Lerdal A. Pain characteristics and self-rated health after elective orthopaedic surgery - a cross-sectional survey. J Clin Nurs. 2013 May;22(9-10):1242-53. doi: 10.1111/jocn.12149. Epub 2013 Mar 29.
- Background: PubMed 28898151Desai N. Postoperative analgesia for shoulder surgery. Br J Hosp Med (Lond). 2017 Sep 2;78(9):511-515. doi: 10.12968/hmed.2017.78.9.511.
- Background: PubMed 28968280Hussain N, Goldar G, Ragina N, Banfield L, Laffey JG, Abdallah FW. Suprascapular and Interscalene Nerve Block for Shoulder Surgery: A Systematic Review and Meta-analysis. Anesthesiology. 2017 Dec;127(6):998-1013. doi: 10.1097/ALN.0000000000001894.
- Background: PubMed 23353796Vandepitte C, Gautier P, Xu D, Salviz EA, Hadzic A. Effective volume of ropivacaine 0.75% through a catheter required for interscalene brachial plexus blockade. Anesthesiology. 2013 Apr;118(4):863-7. doi: 10.1097/ALN.0b013e3182850dc7.
- Background: PubMed 24880194Lee JJ, Kim DY, Hwang JT, Lee SS, Hwang SM, Kim GH, Jo YG. Effect of ultrasonographically guided axillary nerve block combined with suprascapular nerve block in arthroscopic rotator cuff repair: a randomized controlled trial. Arthroscopy. 2014 Aug;30(8):906-14. doi: 10.1016/j.arthro.2014.03.014. Epub 2014 May 29.
- Background: PubMed 31392721Toma O, Persoons B, Pogatzki-Zahn E, Van de Velde M, Joshi GP; PROSPECT Working Group collaborators. PROSPECT guideline for rotator cuff repair surgery: systematic review and procedure-specific postoperative pain management recommendations. Anaesthesia. 2019 Oct;74(10):1320-1331. doi: 10.1111/anae.14796. Epub 2019 Aug 7.
- Individual participant dataSharing planned: No
Related trials for Shoulder Pain
Active, not recruiting
Comparative Effects of Cyriax Approach With and Without Mobilization With Movement in Shoulder Restriction With Rotator Cuff Tendinopathy
Rotator Cuff Tendinopathy
RecruitingObservational study
Pain Phenotype and Response to Corticosteroid Injection in Patients With Subacromial Pain Syndrome (SAPS)
Subacromial Pain Syndrome, Rotator Cuff Related Shoulder Pain
RecruitingObservational study
Nociplastic Pain in Patients Diagnosed With Subacromial Pain Syndrome (SAPS)
Subacromial Pain Syndrome, Rotator Cuff Related Shoulder Pain
Not yet recruiting
Effects of Different Kinesio Taping Methods in Subacromial Impingement Syndrome
Subacromial Impingement Syndrome
Recruiting
Latissimus Dorsi Strengthening Exercises in Rotator Cuff Tendinopathy
Rotator Cuff Related Shoulder Pain, Rotator Cuff Tendinopathy
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.
Marcelo F Silva, PhD principal investigator
Federal University of Health Science of Porto Alegre
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Suprascapular nerve block, Interscalene Nerve Block and Arthroscopic rotator cuff repair in people with Shoulder Pain and Postoperative Pain, run by Ivan Simionato at 1 site in Brazil.
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 2 inclusion and 5 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 28 Apr 2020. 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 Brazil. 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 Ivan F Simionato, MD (+5551992077188, simionato.md@gmail.com), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Pain intensity: Numeric Pain Rating Scale (time frame: 1 hour after surgery). The study lists 4 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT04364542, which also lists 7 linked publications.
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 28 Apr 2020.