Effect of Suprascapular Nerve Block and Axillary Nerve Block After Arthroscopic Rotator Cuff Repair

Study Overview
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Brief Summary
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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.

Official Title
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Effect of Ultrasound-guided Suprascapular Nerve Block and Axillary Nerve Block in Relieving Postoperative Pain After Arthroscopic Rotator Cuff Repair

Conditions
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Rotator Cuff Tears

Intervention / Treatment
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* Procedure: Preemptive ultrasound-guided suprascapular nerve block and axillary nerve block


Participation Criteria
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Eligibility Criteria
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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.

Ages Eligible for Study
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Minimum Age: 20 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Supportive Care
Allocation: Randomized
Intervention Model: Parallel Assignment
Interventional 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


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: Preemptive ultrasound-guided suprascapular nerve block and axillary nerve block using ropivacaine<br>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 | Procedure: Preemptive ultrasound-guided suprascapular nerve block and axillary nerve block<br>* 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.<br>* Other names: a low fixed dose patient controlled analgesia (PCA);|
| Placebo Comparator: Preemptive ultrasound-guided suprascapular nerve block and axillary nerve block using saline<br>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 | Procedure: Preemptive ultrasound-guided suprascapular nerve block and axillary nerve block<br>* 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.<br>* Other names: a low fixed dose patient controlled analgesia (PCA);|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| visual analog pain scale (VAS) | 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) | 0-10, 0: not satisfied, 10: very much satisfied | preoperative, postoperative 1, 3, 6, 12, 18, 24, 36, 48 hour(s) | 
| plasma Cortisol | ng/mL | preoperative, postoperative 1, 6, 12, 24, 48 hour(s) | 
| IL-6 | pg/mL | preoperative, postoperative 1, 6, 12, 24, 48 hour(s) | 
| IL-8 | pg/mL | preoperative, postoperative 1, 6, 12, 24, 48 hour(s) | 
| IL-1β | pg/mL | preoperative, postoperative 1, 6, 12, 24, 48 hour(s) | 
| Substance P | pg/mL | preoperative, postoperative 1, 6, 12, 24, 48 hour(s) | 
| Serotonin | ng/mL | preoperative, postoperative 1, 6, 12, 24, 48 hour(s) | 
| β -endorphin | pg/mL | preoperative, postoperative 1, 6, 12, 24, 48 hour(s) | 
| norepinephrine | pg/mL | preoperative, postoperative 1, 6, 12, 24, 48 hour(s) | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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suprascapular nerve block(SSNB), axillary nerve block(ANB), visual analog pain scale(VAS), patient's satisfaction(SAT), pain related cytokines, arthroscopic rotator cuff repair