ISB With SSNB & ANB

May 23, 2025 updated by: Jung-Taek Hwang, Chuncheon Sacred Heart Hospital

A Study on the Pain Control Effects of Interscalene Brachial Plexus Block Combined With Suprascapular Nerve Block and Axillary Nerve Block in Ar-throscopic Rotator Cuff Repair: a Randomized Controlled Trial

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.

Study Overview

Status

Recruiting

Conditions

Intervention / Treatment

Study Type

Interventional

Enrollment (Estimated)

100

Phase

  • Not Applicable

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Contact

Study Contact Backup

Study Locations

  • Korea, Republic of
    • Gangwon
      • Chuncheon, Gangwon, Korea, Republic of, 24253
        • Not yet recruiting
        • Hallym University Chuncheon Sacred Heart Hospital
        • Contact:
      • Chuncheon, Gangwon, Korea, Republic of, 24253
        • Recruiting
        • Hallym University Chuncheon Sacred Heart Hospital
        • Contact:

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

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

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

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

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
Experimental: ISB with SSNB & ANB
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
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.
Other Names:
  • a low fixed dose patient controlled analgesia (PCA)
Placebo Comparator: ISB with placebo SSNB & ANB
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
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.
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)
Time Frame: preoperative, postoperative 1, 3, 6, 12, 18, 24, 36, 48 hour(s)
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)
Time Frame: preoperative, postoperative 1, 3, 6, 12, 18, 24, 36, 48 hour(s)
0-10, 0: not satisfied, 10: very much satisfied
preoperative, postoperative 1, 3, 6, 12, 18, 24, 36, 48 hour(s)
plasma Cortisol
Time Frame: preoperative, postoperative 1, 6, 12, 24, 48 hour(s)
ng/mL
preoperative, postoperative 1, 6, 12, 24, 48 hour(s)
IL-6
Time Frame: preoperative, postoperative 1, 6, 12, 24, 48 hour(s)
pg/mL
preoperative, postoperative 1, 6, 12, 24, 48 hour(s)
IL-8
Time Frame: preoperative, postoperative 1, 6, 12, 24, 48 hour(s)
pg/mL
preoperative, postoperative 1, 6, 12, 24, 48 hour(s)
IL-1β
Time Frame: preoperative, postoperative 1, 6, 12, 24, 48 hour(s)
pg/mL
preoperative, postoperative 1, 6, 12, 24, 48 hour(s)
Substance P
Time Frame: preoperative, postoperative 1, 6, 12, 24, 48 hour(s)
pg/mL
preoperative, postoperative 1, 6, 12, 24, 48 hour(s)
Serotonin
Time Frame: preoperative, postoperative 1, 6, 12, 24, 48 hour(s)
ng/mL
preoperative, postoperative 1, 6, 12, 24, 48 hour(s)
β -endorphin
Time Frame: preoperative, postoperative 1, 6, 12, 24, 48 hour(s)
pg/mL
preoperative, postoperative 1, 6, 12, 24, 48 hour(s)
norepinephrine
Time Frame: preoperative, postoperative 1, 6, 12, 24, 48 hour(s)
pg/mL
preoperative, postoperative 1, 6, 12, 24, 48 hour(s)

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Chuncheon Sacred Heart Hospital

Investigators

  • Principal Investigator: Jung-Taek Hwang, MD, PhD, Hallym University Medical Center

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

General Publications

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

March 24, 2025

Primary Completion (Estimated)

January 31, 2027

Study Completion (Estimated)

January 31, 2027

Study Registration Dates

First Submitted

March 13, 2025

First Submitted That Met QC Criteria

March 13, 2025

First Posted (Actual)

March 17, 2025

Study Record Updates

Last Update Posted (Actual)

May 29, 2025

Last Update Submitted That Met QC Criteria

May 23, 2025

Last Verified

March 1, 2025

More Information

Terms related to this study

Additional Relevant MeSH Terms

Other Study ID Numbers

  • 2024-12-010-003

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

product manufactured in and exported from the U.S.

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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