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

NCT ID: NCT06055478

Last Updated: 2023-10-04

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

UNKNOWN

Clinical Phase

NA

Total Enrollment

100 participants

Study Classification

INTERVENTIONAL

Study Start Date

2023-09-25

Study Completion Date

2025-09-20

Brief Summary

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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.

Detailed Description

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Conditions

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Rotator Cuff Tears

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

Study group: Preemptive US guided suprascapular nerve block (SSNB) and axillary nerve block (ANB) using each 0.75% ropivacaine 10mL Control group: Preemptive US guided 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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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

Group Type EXPERIMENTAL

Preemptive ultrasound-guided suprascapular nerve block and axillary nerve block

Intervention Type PROCEDURE

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.

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

Group Type PLACEBO_COMPARATOR

Preemptive ultrasound-guided suprascapular nerve block and axillary nerve block

Intervention Type PROCEDURE

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.

Interventions

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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.

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

Sponsors

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Hallym University Medical Center

OTHER

Sponsor Role collaborator

Chuncheon Sacred Heart Hospital

OTHER

Sponsor Role lead

Responsible Party

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Jung-Taek Hwang

Professor

Responsibility Role PRINCIPAL_INVESTIGATOR

Principal Investigators

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Jung-Taek Hwang, MD,PhD

Role: PRINCIPAL_INVESTIGATOR

Hallym University Medical Center

Locations

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Jung-Taek Hwang

Chuncheon, Gangwon-do, South Korea

Site Status RECRUITING

Countries

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South Korea

Central Contacts

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Jung-Taek Hwang, MD, PhD

Role: CONTACT

+82332405197

Ju Sun Kim

Role: CONTACT

+82332405198

Facility Contacts

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Jung-Taek Hwang, MD, PhD

Role: primary

+82332405197

References

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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.

Reference Type RESULT
PMID: 32975624 (View on PubMed)

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.

Reference Type RESULT
PMID: 24880194 (View on PubMed)

Other Identifiers

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2023-07-017-001

Identifier Type: -

Identifier Source: org_study_id

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