Rotator Cuff TearsNCT06055478
Effect of Suprascapular Nerve Block and Axillary Nerve Block After Arthroscopic Rotator Cuff Repair
A study testing Preemptive ultrasound-guided suprascapular nerve block and axillary nerve block in people with Rotator Cuff Tears, run by Chuncheon Sacred Heart Hospital at 1 site in South Korea.
Trial summary
The goal of this clinical trial is to verify the effect of suprascapular nerve block and axillary nerve block in relieving postoperative pain after arthroscopic rotator cuff repair. Read more about this study
- Who is it for?
- Ages 20 years and older
- Conditions the study is for
- Rotator Cuff Tears
- What is being tested?
- Preemptive ultrasound-guided 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
- 71 participants
- Where
- 1 siteSouth Korea
- Study dates
- 16 Oct 2023to 30 May 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 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
1 site in 1 country.
About this study
Official title: Effect of Ultrasound-guided Suprascapular Nerve Block and Axillary Nerve Block in Relieving Postoperative Pain After Arthroscopic Rotator Cuff Repair
The goal of this clinical trial is to verify the effect of suprascapular nerve block and axillary nerve block in relieving postoperative pain after arthroscopic rotator cuff repair.
Are there differences in visual analog pain scale and patient's satisfaction? Are there differences in mean plasma pain related cytokines? The participants will undergo preemptive ultrasound guided suprascapular nerve block and axillary nerve block using each 0.75% ropivacaine 10mL or each 0.9% saline 10mL.
- Conditions
- Rotator Cuff Tears
- Being tested
- Preemptive ultrasound-guided suprascapular nerve block and axillary nerve block
- Keywords
- suprascapular nerve block(SSNB), axillary nerve block(ANB), visual analog pain scale(VAS), patient's satisfaction(SAT), pain related cytokines, arthroscopic rotator cuff repair
- 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 suprascapular nerve block and axillary nerve blockProcedure or surgery
Also called a low fixed dose patient controlled analgesia (PCA)
Preemptive ultrasound-guided 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 |
|---|---|---|
| Preemptive ultrasound-guided suprascapular nerve block and axillary nerve block using ropivacaine | Experimental | Preemptive ultrasound-guided suprascapular nerve block and axillary nerve block using each 0.75% ropivacaine 10mL when arthroscopic rotator cuff repair 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 suprascapular nerve block and axillary nerve block |
| Preemptive ultrasound-guided suprascapular nerve block and axillary nerve block using saline | Placebo comparator | Preemptive ultrasound-guided suprascapular nerve block and axillary nerve block using each 0.9% saline 10mL when arthroscopic rotator cuff repair 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 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 (8)
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)
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 posted26 Sep 2023
- Study start16 Oct 2023
- Primary completion8 Nov 2024
- Study completion30 May 2025
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 TearsStudies 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 suprascapular nerve block (SSNB) and axillary nerve block (ANB) using each 0.75% ropivacaine 10mL Control group: Preemptive US guided 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
- 71 participants (actual)
Sponsor and investigators
- Lead sponsor
- Chuncheon Sacred Heart Hospital
- Sponsor type
- University, hospital or other
- Collaborators
- Hallym University Medical Center
- 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
- NCT06055478
- Sponsor's protocol ID
- 2023-07-017-001
- Status last verified
- Aug 2026
- First submitted
- 15 Sep 2023
- Last updated
- 20 Aug 2026
- 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, 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 32975624Lee 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 24880194
Study at a glance
From the registry record, last updated by the sponsor on 20 Aug 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Effect of Ultrasound-guided Suprascapular Nerve Block and Axillary Nerve Block in Relieving Postoperative Pain After Arthroscopic Rotator Cuff Repair
- ClinicalTrials.gov ID
- NCT06055478
- Acronym / sponsor ID
- 2023-07-017-001
- Conditions
- Rotator Cuff Tears
- Keywords
- suprascapular nerve block(SSNB), axillary nerve block(ANB), visual analog pain scale(VAS), patient's satisfaction(SAT), pain related cytokines, arthroscopic rotator cuff repair
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 71 participants (actual)
- Lead sponsor
- Chuncheon Sacred Heart HospitalUniversity, hospital or other
- Collaborators
- Hallym University Medical Center
- Study start
- 16 Oct 2023 (actual)
- Primary completion
- 8 Nov 2024 (actual)
- Study completion
- 30 May 2025 (actual)
- First posted
- 26 Sep 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.
The goal of this clinical trial is to verify the effect of suprascapular nerve block and axillary nerve block in relieving postoperative pain after arthroscopic rotator cuff repair.
Are there differences in visual analog pain scale and patient's satisfaction? Are there differences in mean plasma pain related cytokines? The participants will undergo preemptive ultrasound guided suprascapular nerve block and axillary nerve block using each 0.75% ropivacaine 10mL or each 0.9% saline 10mL.
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 suprascapular nerve block (SSNB) and axillary nerve block (ANB) using each 0.75% ropivacaine 10mL Control group: Preemptive US guided suprascapular nerve block (SSNB) and axillary nerve block (ANB) using each 0.9% saline 10mL
| Arm | Type | Receives |
|---|---|---|
| Preemptive ultrasound-guided suprascapular nerve block and axillary nerve block using ropivacaine | Experimental | Procedure: Preemptive ultrasound-guided suprascapular nerve block and axillary nerve blockPreemptive ultrasound-guided suprascapular nerve block and axillary nerve block using each 0.75% ropivacaine 10mL when arthroscopic rotator cuff repair 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 |
| Preemptive ultrasound-guided suprascapular nerve block and axillary nerve block using saline | Placebo comparator | Procedure: Preemptive ultrasound-guided suprascapular nerve block and axillary nerve blockPreemptive ultrasound-guided suprascapular nerve block and axillary nerve block using each 0.9% saline 10mL when arthroscopic rotator cuff repair 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 suprascapular nerve block and axillary nerve blockAlso: a low fixed dose patient controlled analgesia (PCA)Preemptive ultrasound-guided 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 | Preemptive ultrasound-guided suprascapular nerve block and axillary nerve block using ropivacaine, Preemptive ultrasound-guided suprascapular nerve block and axillary nerve block using saline |
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
8 secondary outcomes
Patient's satisfaction (SAT)
Time frame: preoperative, postoperative 1, 3, 6, 12, 18, 24, 36, 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
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 20 Aug 2026.
- 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.
- 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.
- Individual participant dataSharing planned: No. We can decide it after the termination of this study.
Related trials for Rotator Cuff Tears
Active, not recruitingPhase 1
E-CEL UVEC Cells as an Adjunct Cell Therapy for the Arthroscopic Rotator Cuff Repair in Adults
Rotator Cuff Tears, Muscle Atrophy or Weakness
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Voll Non-Degradable Shoulder Spacer FIH Study
Massive Rotator Cuff Tears, Massive Rotator Cuff Tear
Active, not recruitingPhase 2
Influence of an Anti-osteoporotic Drug on Healing After Surgical Repair of Chronic Rotator Cuff Lesions of the Shoulder
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Recruiting
SMR Stemless Reverse vs SMR Reverse Shoulder System
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Active, not recruiting
BioBrace® Implant for Arthroscopic Repair of Full Thickness Rotator Cuff Tears
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.
Jung-Taek Hwang, MD,PhD principal investigator
Hallym University Medical Center
1 site 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 suprascapular nerve block and axillary nerve block in people with Rotator Cuff Tears, run by Chuncheon Sacred Heart Hospital at 1 site 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: finished, as of the sponsor's last update on 20 Aug 2026. 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 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?
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?
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 NCT06055478, 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 20 Aug 2026.