ISB With SSNB & ANB

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

RECRUITING

Clinical Phase

NA

Total Enrollment

100 participants

Study Classification

INTERVENTIONAL

Study Start Date

2025-03-24

Study Completion Date

2027-01-31

Brief Summary

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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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Detailed Description

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Conditions

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Rotator Cuff Tear

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

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

Primary Study Purpose

SUPPORTIVE_CARE

Blinding Strategy

QUADRUPLE

Participants Caregivers Investigators Outcome Assessors

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.

Study Groups

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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

Group Type EXPERIMENTAL

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

Intervention Type 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.

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

Group Type PLACEBO_COMPARATOR

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

Intervention Type 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.

Interventions

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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.

Intervention Type PROCEDURE

Other Intervention Names

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a low fixed dose patient controlled analgesia (PCA)

Eligibility Criteria

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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.

Minimum Eligible Age

20 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No