ISB With SSNB & ANB

Chuncheon Sacred Heart Hospital

Status: Enrolling

Conditions: Rotator Cuff Tear

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

Study type: Interventional

Funder types: Other

Identifiers

NCT06878391

2024-12-010-003

Details and patient eligibility

About

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.

Enrollment: 100 estimated patients

Sex: All

Ages: 20+ years old

Volunteers: No Healthy Volunteers

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.

Trial design

Primary purpose: Supportive Care

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: Quadruple Blind

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100 participants in 2 patient groups, including a placebo group

ISB with SSNB & ANB

Experimental group

Description:

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

Treatment:

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

ISB with placebo SSNB & ANB

Placebo Comparator group

Description:

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

Treatment:

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