Clinical trial NCT06878391: ISB With SSNB & ANB
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
Study type: INTERVENTIONAL
Overall status: RECRUITING
Phase: NA
Conditions: Rotator Cuff Tear
Lead sponsor: Chuncheon Sacred Heart Hospital
Sponsor class: OTHER
First posted: 2025-03-17
Enrollment: 100
Sex: ALL
Minimum age (years): 20
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Intervention 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
Primary purpose: SUPPORTIVE_CARE

Brief 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% 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.


Eligibility criteria: 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.

Primary outcomes:
measure: visual analog pain scale (VAS)
timeFrame: preoperative, postoperative 1, 3, 6, 12, 18, 24, 36, 48 hour(s)
Secondary outcomes:
measure: Patient's satisfaction (SAT)
timeFrame: preoperative, postoperative 1, 3, 6, 12, 18, 24, 36, 48 hour(s)
measure: plasma Cortisol
timeFrame: preoperative, postoperative 1, 6, 12, 24, 48 hour(s)
measure: IL-6
timeFrame: preoperative, postoperative 1, 6, 12, 24, 48 hour(s)
measure: IL-8
timeFrame: preoperative, postoperative 1, 6, 12, 24, 48 hour(s)
measure: IL-1β
timeFrame: preoperative, postoperative 1, 6, 12, 24, 48 hour(s)
measure: Substance P
timeFrame: preoperative, postoperative 1, 6, 12, 24, 48 hour(s)
measure: Serotonin
timeFrame: preoperative, postoperative 1, 6, 12, 24, 48 hour(s)
measure: β -endorphin
timeFrame: preoperative, postoperative 1, 6, 12, 24, 48 hour(s)
measure: norepinephrine
timeFrame: preoperative, postoperative 1, 6, 12, 24, 48 hour(s)
Other outcomes:
Locations:
city: Chuncheon
country: Korea, Republic of
facility: Hallym University Chuncheon Sacred Heart Hospital
state: Gangwon
city: Chuncheon
country: Korea, Republic of
facility: Hallym University Chuncheon Sacred Heart Hospital
state: Gangwon
Study officials:
affiliation: Hallym University Medical Center
name: Jung-Taek Hwang, MD, PhD
role: PRINCIPAL_INVESTIGATOR
References:
citation: 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.
citation: 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.