Clinical trial NCT06055478: Effect of Suprascapular Nerve Block and Axillary Nerve Block After Arthroscopic Rotator Cuff Repair
Official title: Effect of Ultrasound-guided Suprascapular Nerve Block and Axillary Nerve Block in Relieving Postoperative Pain After Arthroscopic Rotator Cuff Repair
Study type: INTERVENTIONAL
Overall status: RECRUITING
Phase: NA
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
Lead sponsor: Chuncheon Sacred Heart Hospital
Sponsor class: OTHER
Collaborators: name: Hallym University Medical Center
First posted: 2023-09-26
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 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
Primary purpose: SUPPORTIVE_CARE

Brief 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.

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.


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: Jung-Taek Hwang
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, 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.
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.