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

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

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.

Study Overview

• Status: Recruiting
• Conditions: Rotator Cuff Tears
• Intervention / Treatment: Procedure: Preemptive ultrasound-guided suprascapular nerve block and axillary nerve block

• Study Type: Interventional
• Enrollment (Estimated): 100
• Phase: Not Applicable

Contacts and Locations

• Study Contact: Name: Jung-Taek Hwang, MD, PhD; Phone Number: +82332405197; Email: drakehjt@hanmail.net
• Study Contact Backup: Name: Ju Sun Kim; Phone Number: +82332405198; Email: wntjs2263@naver.com

Study Locations

• Korea, Republic of
  • Gangwon
    • Chuncheon, Gangwon, Korea, Republic of, 24253
      • Recruiting
      • Jung-Taek Hwang
      • Contact: Jung-Taek Hwang, MD, PhD; Phone Number: +82332405197; Email: drakehjt@hanmail.net

Participation Criteria

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

How is the study designed?

Design Details

• Primary Purpose: Supportive Care
• Allocation: Randomized
• Interventional Model: Parallel Assignment
• Masking: Quadruple

Number of Arms

2

Arms and Interventions

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

What is the study measuring?

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)

Collaborators and Investigators

• Sponsor: Chuncheon Sacred Heart Hospital
• Collaborators: Hallym University Medical Center
• Investigators: Principal Investigator: Jung-Taek Hwang, MD,PhD, Hallym University Medical Center

Publications and helpful links

General Publications

• 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.
• 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.

Study record dates

Study Major Dates

• Study Start (Actual): September 25, 2023
• Primary Completion (Estimated): September 18, 2025
• Study Completion (Estimated): September 20, 2025

Study Registration Dates

• First Submitted: September 15, 2023
• First Submitted That Met QC Criteria: September 20, 2023
• First Posted (Actual): September 26, 2023

Study Record Updates

• Last Update Posted (Actual): October 4, 2023
• Last Update Submitted That Met QC Criteria: October 3, 2023
• Last Verified: October 1, 2023

More Information

Terms related to this study

• Keywords: arthroscopic rotator cuff repair; suprascapular nerve block(SSNB); axillary nerve block(ANB); visual analog pain scale(VAS); patient's satisfaction(SAT); pain related cytokines
• Additional Relevant MeSH Terms: Wounds and Injuries; Rupture; Shoulder Injuries; Tendon Injuries; Rotator Cuff Injuries
• Other Study ID Numbers: 2023-07-017-001

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