ISB With SSNB & ANB

NCT06878391 | Recruiting DMC

• 1 other identifier: 2024-12-010-003
• Study Type: interventional
• Target: 100
• Locations: 1 country
• Sites: 2

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.

Conditions

Rotator Cuff Tear

Outcome Measures

Primary Outcomes (1)

• 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 Outcomes (9)

• Patient's satisfaction (SAT)

  preoperative, postoperative 1, 3, 6, 12, 18, 24, 36, 48 hour(s)

• plasma Cortisol

  preoperative, postoperative 1, 6, 12, 24, 48 hour(s)

• IL-6

  preoperative, postoperative 1, 6, 12, 24, 48 hour(s)

• IL-8

  preoperative, postoperative 1, 6, 12, 24, 48 hour(s)

• IL-1β

  preoperative, postoperative 1, 6, 12, 24, 48 hour(s)

Study Arms (2)

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

Procedure: Preemptive ultrasound-guided interscalene brachial plexus block and suprascapular nerve block and axillary nerve block

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

Procedure: Preemptive ultrasound-guided interscalene brachial plexus block and suprascapular nerve block and axillary nerve block

Interventions

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.

Also known as: a low fixed dose patient controlled analgesia (PCA)

ISB with SSNB & ANB; ISB with placebo SSNB & ANB

Eligibility Criteria

• Age: 20 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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

You may not qualify if:

• 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.

Sponsors & Collaborators

• Chuncheon Sacred Heart Hospital: lead

Study Sites (2)

Hallym University Chuncheon Sacred Heart Hospital

Chuncheon, Gangwon-do, 24253, South Korea

NOT YET RECRUITING

Hallym University Chuncheon Sacred Heart Hospital

Chuncheon, Gangwon-do, 24253, South Korea

RECRUITING

Related Publications (2)

• 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.

  PMID: 24880194 BACKGROUND

• 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.

  PMID: 32975624 BACKGROUND

MeSH Terms

Conditions

Rotator Cuff Injuries

Interventions

Analgesia, Patient-Controlled

Condition Hierarchy (Ancestors)

Rupture; Wounds and Injuries; Shoulder Injuries; Tendon Injuries

Intervention Hierarchy (Ancestors)

Analgesia; Anesthesia and Analgesia

Study Officials

• Jung-Taek Hwang, MD, PhD

  Hallym University Medical Center

  PRINCIPAL INVESTIGATOR

Central Study Contacts

Jung-Taek Hwang, MD, PhD

CONTACT

+82332405197; drakehjt@hanmail.net

Su-Jung Seo, PhD

CONTACT

asasa4444@naver.com

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: QUADRUPLE
• Who Masked: PARTICIPANT, CARE PROVIDER, INVESTIGATOR, OUTCOMES ASSESSOR
• Masking Details: 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.
• Purpose: SUPPORTIVE CARE
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Professor

Model Details: 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

Study Record Dates

• First Submitted: March 13, 2025
• First Posted: March 17, 2025
• Study Start: March 24, 2025
• Primary Completion (Estimated): January 31, 2027
• Study Completion (Estimated): January 31, 2027
• Last Updated: May 29, 2025

Record last verified: 2025-03

Data Sharing

• IPD Sharing: Will not share

Locations

KR (2)