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

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Primary Purpose

Status

Recruiting

Phase

Not Applicable

Locations

Korea, Republic of

Study Type

Interventional

Intervention

Preemptive ultrasound-guided suprascapular nerve block and axillary nerve block

About this trial

This is an interventional supportive care trial for Rotator Cuff Tears focused on measuring suprascapular nerve block(SSNB), axillary nerve block(ANB), visual analog pain scale(VAS), patient's satisfaction(SAT), pain related cytokines, arthroscopic rotator cuff repair

Eligibility Criteria

20 Years - undefined (Adult, Older Adult)All SexesDoes not accept 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.

Sites / Locations

Jung-Taek HwangRecruiting

Arms of the Study

Arm 1

Arm 2

Arm Type

Experimental

Placebo Comparator

Arm Label

Preemptive ultrasound-guided suprascapular nerve block and axillary nerve block using ropivacaine

Preemptive ultrasound-guided suprascapular nerve block and axillary nerve block using saline

Arm Description

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

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

Outcomes

Primary Outcome Measures

visual analog pain scale (VAS)

0-10, 0: no pain, 10: very severe pain

Secondary Outcome Measures

Patient's satisfaction (SAT)

0-10, 0: not satisfied, 10: very much satisfied

plasma Cortisol

ng/mL

IL-6

pg/mL

IL-8

pg/mL

IL-1β

pg/mL

Substance P

pg/mL

Serotonin

ng/mL

β -endorphin

pg/mL

norepinephrine

pg/mL

Full Information

NCT ID

NCT06055478

First Posted

September 15, 2023

Last Updated

October 3, 2023

Sponsor

Chuncheon Sacred Heart Hospital

Collaborators

Hallym University Medical Center

1. Study Identification

Unique Protocol Identification Number

NCT06055478

Brief Title

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

Official Title

Effect of Ultrasound-guided Suprascapular Nerve Block and Axillary Nerve Block in Relieving Postoperative Pain After Arthroscopic Rotator Cuff Repair

Study Type

Interventional

2. Study Status

Record Verification Date

October 2023

Overall Recruitment Status

Recruiting

Study Start Date

September 25, 2023 (Actual)

Primary Completion Date

September 18, 2025 (Anticipated)

Study Completion Date

September 20, 2025 (Anticipated)

3. Sponsor/Collaborators

Responsible Party, by Official Title

Principal Investigator

Name of the Sponsor

Chuncheon Sacred Heart Hospital

Collaborators

Hallym University Medical Center

4. Oversight

Studies a U.S. FDA-regulated Drug Product

No

Studies a U.S. FDA-regulated Device Product

No

Data Monitoring Committee

Yes

5. Study Description

Brief Summary

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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study

Rotator Cuff Tears

Keywords

suprascapular nerve block(SSNB), axillary nerve block(ANB), visual analog pain scale(VAS), patient's satisfaction(SAT), pain related cytokines, arthroscopic rotator cuff repair

7. Study Design

Primary Purpose

Supportive Care

Study Phase

Not Applicable

Interventional Study Model

Parallel Assignment

Model Description

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

Masking

ParticipantCare ProviderInvestigatorOutcomes Assessor

Masking Description

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.

Allocation

Randomized

Enrollment

100 (Anticipated)

8. Arms, Groups, and Interventions

Arm Title

Preemptive ultrasound-guided suprascapular nerve block and axillary nerve block using ropivacaine

Arm Type

Experimental

Arm Description

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

Arm Title

Preemptive ultrasound-guided suprascapular nerve block and axillary nerve block using saline

Arm Type

Placebo Comparator

Arm Description

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

Intervention Type

Procedure

Intervention Name(s)

Preemptive ultrasound-guided suprascapular nerve block and axillary nerve block

Other Intervention Name(s)

a low fixed dose patient controlled analgesia (PCA)

Intervention Description

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.

Primary Outcome Measure Information:

Title

visual analog pain scale (VAS)

Description

0-10, 0: no pain, 10: very severe pain

Time Frame

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

Secondary Outcome Measure Information:

Title

Patient's satisfaction (SAT)

Description

0-10, 0: not satisfied, 10: very much satisfied

Time Frame

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

Title

plasma Cortisol

Description

ng/mL

Time Frame