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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.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| ISB with SSNB & ANB | Experimental | 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 |
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| ISB with placebo SSNB & ANB | Placebo Comparator | 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 |
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| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Preemptive ultrasound-guided interscalene brachial plexus block and suprascapular nerve block and axillary nerve block | Procedure | 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. |
| 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) |
| 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 |
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Inclusion Criteria:
Exclusion Criteria:
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| Name | Role | Phone | Extension | |
|---|---|---|---|---|
| Jung-Taek Hwang, MD, PhD | Contact | +82332405197 | drakehjt@hanmail.net | |
| Su-Jung Seo, PhD | Contact | asasa4444@naver.com |
| Name | Affiliation | Role |
|---|---|---|
| Jung-Taek Hwang, MD, PhD | Hallym University Medical Center | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Hallym University Chuncheon Sacred Heart Hospital | Not yet recruiting | Chuncheon | Gangwon-do | 24253 | South Korea |
| PubMed Identifier | Type | Citation | Retractions |
|---|---|---|---|
| 24880194 | Result | 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. | |
| 32975624 | Result |
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We can decide it after the termination of this study.
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| ID | Term |
|---|---|
| D000070636 | Rotator Cuff Injuries |
| ID | Term |
|---|---|
| D012421 | Rupture |
| D014947 | Wounds and Injuries |
| D000070599 | Shoulder Injuries |
| D013708 | Tendon Injuries |
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| ID | Term |
|---|---|
| D016058 | Analgesia, Patient-Controlled |
| ID | Term |
|---|---|
| D000698 | Analgesia |
| D000760 | Anesthesia and Analgesia |
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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
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An independent nurse uses a random number generator and allocates paticipants into the two group. Participant, investigator, and outcome assessor are blinded of the allocation information.
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| 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) |
| Hallym University Chuncheon Sacred Heart Hospital | Recruiting | Chuncheon | Gangwon-do | 24253 | South Korea |
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| 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. |