Rotator Cuff TearNCT06878391
ISB With SSNB & ANB
A study testing Preemptive ultrasound-guided interscalene brachial plexus block and suprascapular nerve block and axillary nerve block in people with Rotator Cuff Tear, run by Chuncheon Sacred Heart Hospital at 2 sites in South Korea.
Trial summary
This study is a prospective, randomized, double-blind trial comparing patients who underwent arthroscopic rotator cuff repair and received an interscalene brachial plexus block (9 ml of 0.75% ropivacaine, 3 ml for each trunk) combined with suprascapular nerve block and axillary nerve block (each with 10 ml of 0.75%… Read more about this study
- Who is it for?
- Ages 20 years and older
- Conditions the study is for
- Rotator Cuff Tear
- What is being tested?
- Preemptive ultrasound-guided interscalene brachial plexus block and suprascapular nerve block and axillary nerve block
- Type of treatment
- Surgery or procedure
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 100 participants
- Where
- 2 sitesSouth Korea
- Study dates
- 24 Mar 2025to 31 Jan 2027
- Phase
- Interventional
- Are there results?
- Not yet: the study is under way
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 20 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- a definite rotator cuff tear that needed repair seen on preoperative magnetic resonancce imaging (MRI)
- acceptance of arthroscopic surgery including rotator cuff repair
- age same as or more than 20 years
- acceptance of preemptive regional block and PCA, and blood testing
Who cannot join
- did not undergo arthroscopic rotator cuff repair
- stopped PCA before 48 hours postoperatively because of associated side effects
- a history of previous ipsilateral shoulder operation or fracture
- a concomitant neurologic disorder around the shoulder
- a failure of blood sampling including hemolysis, etc.
Trial locations and contacts
2 sites in 1 country. Contact the study team or a site near you to ask about taking part.
Su-Jung Seo, PhD contact
South Korea2 sites, 2 recruiting
- Not yet recruiting
Hallym University Chuncheon Sacred Heart Hospital
Chuncheon, Gangwon-do, 24253
Su-Jung Seo, PhD, +82332405197, asasa4444@naver.com
- Recruiting
Hallym University Chuncheon Sacred Heart Hospital
Chuncheon, Gangwon-do, 24253
Su-Jung Seo, PhD, +82332405197, asasa4444@naver.com
About this study
Official title: A Study on the Pain Control Effects of Interscalene Brachial Plexus Block Combined With Suprascapular Nerve Block and Axillary Nerve Block in Ar-throscopic Rotator Cuff Repair: a Randomized Controlled Trial
This study is a prospective, randomized, double-blind trial comparing patients who underwent arthroscopic rotator cuff repair and received an interscalene brachial plexus block (9 ml of 0.75% ropivacaine, 3 ml for each trunk) combined with suprascapular nerve block and axillary nerve block (each with 10 ml of 0.75% ropivacaine) versus those who received an interscalene brachial plexus block (9 ml of 0.75% ropivacaine, 3 ml for each trunk) combined with placebo suprascapular and axillary nerve blocks (each with 10 ml of 0.9% saline).
The study will compare subjective pain scores (VAS score) and patient satisfaction preoperatively and at 1, 3, 6, 12, 18, 24, 36, and 48 hours postoperatively. Additionally, 5 ml of venous blood will be collected preoperatively and at 1, 6, 12, 24, and 48 hours postoperatively to analyze and compare serum levels of cortisol, IL-6, IL-8, IL-1β, substance P, serotonin, β-endorphin, and norepinephrine.
- Conditions
- Rotator Cuff Tear
- Being tested
- Preemptive ultrasound-guided interscalene brachial plexus block and suprascapular nerve block and axillary nerve block
- Medical subject headings
- Rotator Cuff Injuries
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Preemptive ultrasound-guided interscalene brachial plexus block and suprascapular nerve block and axillary nerve blockProcedure or surgery
Also called a low fixed dose patient controlled analgesia (PCA)
Preemptive ultrasound-guided interscalene brachial plexus block using ropivacaine, and suprascapular nerve block and axillary nerve block using ropivacaine or saline. Low fixed dose patient controlled analgesia (PCA) were done in the two group.
| Study group | Role | What they receive |
|---|---|---|
| ISB with SSNB & ANB | Experimental | An ultrasound-guided interscalene brachial plexus block (9 ml of 0.75% ropivacaine, 3 ml for each trunk) is performed immediately before arthroscopic rotator cuff repair , along with suprascapular nerve block and axillary nerve block (each with 10 ml of 0.75% ropivacaine). Patient Controlled Analgesia (PCA) at a low fixed dose: fentanyl-loading dose: 0.4㎍/kg, continuous dose: 0.2㎍/kg/h, nefopam-loading dose: 0.04mg/kg, continuous dose: 0.02mg/kg/h Receives: Procedure: Preemptive ultrasound-guided interscalene brachial plexus block and suprascapular nerve block and axillary nerve block |
| ISB with placebo SSNB & ANB | Placebo comparator | An ultrasound-guided interscalene brachial plexus block (9 ml of 0.75% ropivacaine, 3 ml for each trunk) is performed immediately before arthroscopic rotator cuff repair , along with suprascapular nerve block and axillary nerve block (each with 10 ml of saline). Patient Controlled Analgesia (PCA) at a low fixed dose: fentanyl-loading dose: 0.4㎍/kg, continuous dose: 0.2㎍/kg/h, nefopam-loading dose: 0.04mg/kg, continuous dose: 0.02mg/kg/h Receives: Procedure: Preemptive ultrasound-guided interscalene brachial plexus block and suprascapular nerve block and axillary nerve block |
What is being measured
The primary outcome is the main question the study is designed to answer.
visual analog pain scale (VAS)
0-10, 0: no pain, 10: very severe pain
Measured: preoperative, postoperative 1, 3, 6, 12, 18, 24, 36, 48 hour(s)
Secondary outcomes (9)
Patient's satisfaction (SAT)
0-10, 0: not satisfied, 10: very much satisfied
Measured: preoperative, postoperative 1, 3, 6, 12, 18, 24, 36, 48 hour(s)
plasma Cortisol
ng/mL
Measured: preoperative, postoperative 1, 6, 12, 24, 48 hour(s)
IL-6
pg/mL
Measured: preoperative, postoperative 1, 6, 12, 24, 48 hour(s)
IL-8
pg/mL
Measured: preoperative, postoperative 1, 6, 12, 24, 48 hour(s)
IL-1β
pg/mL
Measured: preoperative, postoperative 1, 6, 12, 24, 48 hour(s)
Substance P
pg/mL
Measured: preoperative, postoperative 1, 6, 12, 24, 48 hour(s)
Serotonin
ng/mL
Measured: preoperative, postoperative 1, 6, 12, 24, 48 hour(s)
β -endorphin
pg/mL
Measured: preoperative, postoperative 1, 6, 12, 24, 48 hour(s)
norepinephrine
pg/mL
Measured: preoperative, postoperative 1, 6, 12, 24, 48 hour(s)
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted17 Mar 2025
- Study start24 Mar 2025
- Primary completion31 Jan 2027 (estimated)
- Study completion31 Jan 2027 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (2)Papers the sponsor has linked to this study.
- 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 N/A
- Primary purpose
- Supportive care
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Model description
- Study group: Preemptive US guided interscalene brachial plexus block (9ml 0.75% ropivacaine, 3ml for each trunk), and suprascapular nerve block (SSNB) and axillary nerve block (ANB) using each 0.75% ropivacaine 10mL Control group: Preemptive US guided interscalene brachial plexus block (9ml 0.75% ropivacaine, 3ml for each trunk), and suprascapular nerve block (SSNB) and axillary nerve block (ANB) using each 0.9% saline 10mL
- Masking
- Quadruple blind
- Who is masked
- Participant, Care provider, Investigator, Outcomes assessor
- Enrolment
- 100 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Chuncheon Sacred Heart Hospital
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Jung-Taek Hwang, Chuncheon Sacred Heart Hospital
- Investigators
- Jung-Taek Hwang, MD, PhD, Principal investigator, Hallym University Medical Center
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06878391
- Sponsor's protocol ID
- 2024-12-010-003
- Status last verified
- Mar 2025
- First submitted
- 13 Mar 2025
- Last updated
- 29 May 2025
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No: We can decide it after the termination of this study.
Publications
Lee 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 24880194Lee JJ, Kim DY, Hwang JT, Song DK, Lee HN, Jang JS, Lee SS, Hwang SM, Moon SH, Shim JH. Dexmedetomidine combined with suprascapular nerve block and axillary nerve block has a synergistic effect on relieving postoperative pain after arthroscopic rotator cuff repair. Knee Surg Sports Traumatol Arthrosc. 2021 Dec;29(12):4022-4031. doi: 10.1007/s00167-020-06288-8. Epub 2020 Sep 25.
PubMed 32975624
Study at a glance
From the registry record, last updated by the sponsor on 29 May 2025. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- A Study on the Pain Control Effects of Interscalene Brachial Plexus Block Combined With Suprascapular Nerve Block and Axillary Nerve Block in Ar-throscopic Rotator Cuff Repair: a Randomized Controlled Trial
- ClinicalTrials.gov ID
- NCT06878391
- Acronym / sponsor ID
- 2024-12-010-003
- Conditions
- Rotator Cuff Tear
- Study type
- Interventional
- Recruitment status
- Recruiting
- Enrolment
- 100 participants (estimated)
- Lead sponsor
- Chuncheon Sacred Heart HospitalUniversity, hospital or other
- Study start
- 24 Mar 2025 (actual)
- Primary completion
- 31 Jan 2027 (estimated)
- Study completion
- 31 Jan 2027 (estimated)
- First posted
- 17 Mar 2025 (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 is a prospective, randomized, double-blind trial comparing patients who underwent arthroscopic rotator cuff repair and received an interscalene brachial plexus block (9 ml of 0.75% ropivacaine, 3 ml for each trunk) combined with suprascapular nerve block and axillary nerve block (each with 10 ml of 0.75% ropivacaine) versus those who received an interscalene brachial plexus block (9 ml of 0.75% ropivacaine, 3 ml for each trunk) combined with placebo suprascapular and axillary nerve blocks (each with 10 ml of 0.9% saline).
The study will compare subjective pain scores (VAS score) and patient satisfaction preoperatively and at 1, 3, 6, 12, 18, 24, 36, and 48 hours postoperatively. Additionally, 5 ml of venous blood will be collected preoperatively and at 1, 6, 12, 24, and 48 hours postoperatively to analyze and compare serum levels of cortisol, IL-6, IL-8, IL-1β, substance P, serotonin, β-endorphin, and norepinephrine.
Study design
- Primary purpose
- Supportive care
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Quadruple blind (participant, care provider, investigator, outcomes assessor)
- Number of arms
- 2
- Model description
- Study group: Preemptive US guided interscalene brachial plexus block (9ml 0.75% ropivacaine, 3ml for each trunk), and suprascapular nerve block (SSNB) and axillary nerve block (ANB) using each 0.75% ropivacaine 10mL Control group: Preemptive US guided interscalene brachial plexus block (9ml 0.75% ropivacaine, 3ml for each trunk), and suprascapular nerve block (SSNB) and axillary nerve block (ANB) using each 0.9% saline 10mL
| Arm | Type | Receives |
|---|---|---|
| ISB with SSNB & ANB | Experimental | Procedure: Preemptive ultrasound-guided interscalene brachial plexus block and suprascapular nerve block and axillary nerve blockAn ultrasound-guided interscalene brachial plexus block (9 ml of 0.75% ropivacaine, 3 ml for each trunk) is performed immediately before arthroscopic rotator cuff repair , along with suprascapular nerve block and axillary nerve block (each with 10 ml of 0.75% ropivacaine). Patient Controlled Analgesia (PCA) at a low fixed dose: fentanyl-loading dose: 0.4㎍/kg, continuous dose: 0.2㎍/kg/h, nefopam-loading dose: 0.04mg/kg, continuous dose: 0.02mg/kg/h |
| ISB with placebo SSNB & ANB | Placebo comparator | Procedure: Preemptive ultrasound-guided interscalene brachial plexus block and suprascapular nerve block and axillary nerve blockAn ultrasound-guided interscalene brachial plexus block (9 ml of 0.75% ropivacaine, 3 ml for each trunk) is performed immediately before arthroscopic rotator cuff repair , along with suprascapular nerve block and axillary nerve block (each with 10 ml of saline). Patient Controlled Analgesia (PCA) at a low fixed dose: fentanyl-loading dose: 0.4㎍/kg, continuous dose: 0.2㎍/kg/h, nefopam-loading dose: 0.04mg/kg, continuous dose: 0.02mg/kg/h |
Who may qualify
- Ages
- 20 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (4 listed)
- a definite rotator cuff tear that needed repair seen on preoperative magnetic resonancce imaging (MRI)
- acceptance of arthroscopic surgery including rotator cuff repair
- age same as or more than 20 years
- acceptance of preemptive regional block and PCA, and blood testing
Key exclusion criteria (5 listed)
- did not undergo arthroscopic rotator cuff repair
- stopped PCA before 48 hours postoperatively because of associated side effects
- a history of previous ipsilateral shoulder operation or fracture
- a concomitant neurologic disorder around the shoulder
- a failure of blood sampling including hemolysis, etc.
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 |
|---|---|---|
| Preemptive ultrasound-guided interscalene brachial plexus block and suprascapular nerve block and axillary nerve blockAlso: a low fixed dose patient controlled analgesia (PCA)Preemptive ultrasound-guided interscalene brachial plexus block using ropivacaine, and suprascapular nerve block and axillary nerve block using ropivacaine or saline. Low fixed dose patient controlled analgesia (PCA) were done in the two group. | Procedure or surgery | ISB with SSNB & ANB, ISB with placebo SSNB & ANB |
Primary outcome
visual analog pain scale (VAS)
Time frame: preoperative, postoperative 1, 3, 6, 12, 18, 24, 36, 48 hour(s)
0-10, 0: no pain, 10: very severe pain
9 secondary outcomes
Patient's satisfaction (SAT)
Time frame: preoperative, postoperative 1, 3, 6, 12, 18, 24, 36, 48 hour(s)
plasma Cortisol
Time frame: preoperative, postoperative 1, 6, 12, 24, 48 hour(s)
IL-6
Time frame: preoperative, postoperative 1, 6, 12, 24, 48 hour(s)
IL-8
Time frame: preoperative, postoperative 1, 6, 12, 24, 48 hour(s)
IL-1β
Time frame: preoperative, postoperative 1, 6, 12, 24, 48 hour(s)
Substance P
Time frame: preoperative, postoperative 1, 6, 12, 24, 48 hour(s)
Serotonin
Time frame: preoperative, postoperative 1, 6, 12, 24, 48 hour(s)
β -endorphin
Time frame: preoperative, postoperative 1, 6, 12, 24, 48 hour(s)
norepinephrine
Time frame: preoperative, postoperative 1, 6, 12, 24, 48 hour(s)
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 29 May 2025.
- Results publication: 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.
- Results publication: PubMed 32975624Lee JJ, Kim DY, Hwang JT, Song DK, Lee HN, Jang JS, Lee SS, Hwang SM, Moon SH, Shim JH. Dexmedetomidine combined with suprascapular nerve block and axillary nerve block has a synergistic effect on relieving postoperative pain after arthroscopic rotator cuff repair. Knee Surg Sports Traumatol Arthrosc. 2021 Dec;29(12):4022-4031. doi: 10.1007/s00167-020-06288-8. Epub 2020 Sep 25.
- Individual participant dataSharing planned: No. We can decide it after the termination of this study.
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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.
Su-Jung Seo, PhD contact
Jung-Taek Hwang, MD, PhD principal investigator
Hallym University Medical Center
2 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Preemptive ultrasound-guided interscalene brachial plexus block and suprascapular nerve block and axillary nerve block in people with Rotator Cuff Tear, run by Chuncheon Sacred Heart Hospital at 2 sites in South Korea.
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 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: looking for participants now, as of the sponsor's last update on 29 May 2025. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 2 sites in South Korea. 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. Some participants in this study may receive a placebo. 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?
This study is still under way. Results are not available in the source record yet.
How can a doctor refer a patient or contact the research team?
Contact Jung-Taek Hwang, MD, PhD (+82332405197, drakehjt@hanmail.net), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
visual analog pain scale (VAS) (time frame: preoperative, postoperative 1, 3, 6, 12, 18, 24, 36, 48 hour(s)). 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 NCT06878391, which also lists 2 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 29 May 2025; AzTrials last refreshed its copy on 27 Oct 2026.