ISB With SSNB & ANB
May 23, 2025 updated by: Jung-Taek Hwang, Chuncheon Sacred Heart Hospital
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.
Study Overview
Status
Recruiting
Conditions
Study Type
Interventional
Enrollment (Estimated)
100
Phase
- Not Applicable
Contacts and Locations
This section provides the contact details for those conducting the study, and information on where this study is being conducted.
Study Contact
- Name: Jung-Taek Hwang, MD, PhD
- Phone Number: +82332405197
- Email: drakehjt@hanmail.net
Study Contact Backup
- Name: Su-Jung Seo, PhD
- Email: asasa4444@naver.com
Study Locations
-
-
Gangwon
-
Chuncheon, Gangwon, Korea, Republic of, 24253
- Not yet recruiting
- Hallym University Chuncheon Sacred Heart Hospital
-
Contact:
- Su-Jung Seo, PhD
- Phone Number: +82332405197
- Email: asasa4444@naver.com
-
Chuncheon, Gangwon, Korea, Republic of, 24253
- Recruiting
- Hallym University Chuncheon Sacred Heart Hospital
-
Contact:
- Su-Jung Seo, PhD
- Phone Number: +82332405197
- Email: asasa4444@naver.com
-
-
Participation Criteria
Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.
Eligibility Criteria
Ages Eligible for Study
- Adult
- Older Adult
Accepts Healthy Volunteers
No
Description
Inclusion Criteria:
- 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
Exclusion Criteria:
- 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.
Study Plan
This section provides details of the study plan, including how the study is designed and what the study is measuring.
How is the study designed?
Design Details
- Primary Purpose: Supportive Care
- Allocation: Randomized
- Interventional Model: Parallel Assignment
- Masking: Quadruple
Arms and Interventions
Participant Group / Arm |
Intervention / Treatment |
|---|---|
|
Experimental: ISB with SSNB & ANB
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
|
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.
Other Names:
|
|
Placebo Comparator: ISB with placebo SSNB & ANB
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
|
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.
Other Names:
|
What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
|---|---|---|
|
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
|
preoperative, postoperative 1, 3, 6, 12, 18, 24, 36, 48 hour(s)
|
Secondary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
|---|---|---|
|
Patient's satisfaction (SAT)
Time Frame: preoperative, postoperative 1, 3, 6, 12, 18, 24, 36, 48 hour(s)
|
0-10, 0: not satisfied, 10: very much satisfied
|
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)
|
ng/mL
|
preoperative, postoperative 1, 6, 12, 24, 48 hour(s)
|
|
IL-6
Time Frame: preoperative, postoperative 1, 6, 12, 24, 48 hour(s)
|
pg/mL
|
preoperative, postoperative 1, 6, 12, 24, 48 hour(s)
|
|
IL-8
Time Frame: preoperative, postoperative 1, 6, 12, 24, 48 hour(s)
|
pg/mL
|
preoperative, postoperative 1, 6, 12, 24, 48 hour(s)
|
|
IL-1β
Time Frame: preoperative, postoperative 1, 6, 12, 24, 48 hour(s)
|
pg/mL
|
preoperative, postoperative 1, 6, 12, 24, 48 hour(s)
|
|
Substance P
Time Frame: preoperative, postoperative 1, 6, 12, 24, 48 hour(s)
|
pg/mL
|
preoperative, postoperative 1, 6, 12, 24, 48 hour(s)
|
|
Serotonin
Time Frame: preoperative, postoperative 1, 6, 12, 24, 48 hour(s)
|
ng/mL
|
preoperative, postoperative 1, 6, 12, 24, 48 hour(s)
|
|
β -endorphin
Time Frame: preoperative, postoperative 1, 6, 12, 24, 48 hour(s)
|
pg/mL
|
preoperative, postoperative 1, 6, 12, 24, 48 hour(s)
|
|
norepinephrine
Time Frame: preoperative, postoperative 1, 6, 12, 24, 48 hour(s)
|
pg/mL
|
preoperative, postoperative 1, 6, 12, 24, 48 hour(s)
|
Collaborators and Investigators
This is where you will find people and organizations involved with this study.
Sponsor
Investigators
- Principal Investigator: Jung-Taek Hwang, MD, PhD, Hallym University Medical Center
Publications and helpful links
The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.
General 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.
- 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.
Study record dates
These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.
Study Major Dates
Study Start (Actual)
March 24, 2025
Primary Completion (Estimated)
January 31, 2027
Study Completion (Estimated)
January 31, 2027
Study Registration Dates
First Submitted
March 13, 2025
First Submitted That Met QC Criteria
March 13, 2025
First Posted (Actual)
March 17, 2025
Study Record Updates
Last Update Posted (Actual)
May 29, 2025
Last Update Submitted That Met QC Criteria
May 23, 2025
Last Verified
March 1, 2025
More Information
Terms related to this study
Additional Relevant MeSH Terms
Other Study ID Numbers
- 2024-12-010-003
Plan for Individual participant data (IPD)
Plan to Share Individual Participant Data (IPD)?
NO
IPD Plan Description
We can decide it after the termination of this study.
Drug and device information, study documents
Studies a U.S. FDA-regulated drug product
No
Studies a U.S. FDA-regulated device product
No
product manufactured in and exported from the U.S.
No
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