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

Sponsor
Chuncheon Sacred Heart Hospital (Other)
Overall Status
Not yet recruiting
CT.gov ID
NCT06055478
Collaborator
Hallym University Medical Center (Other)
100
Enrollment
2
Arms
24.1
Anticipated Duration (Months)

Study Details

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.

Condition or Disease Intervention/Treatment Phase
  • Procedure: Preemptive ultrasound-guided suprascapular nerve block and axillary nerve block
 N/A

Study Design

Study Type:
Interventional
Anticipated Enrollment :
100 participants
Allocation:
Randomized
Intervention Model:
Parallel Assignment
Intervention 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 10mLStudy 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:
Quadruple (Participant, Care Provider, Investigator, Outcomes 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.
Primary Purpose:
Supportive Care
Official Title:
Effect of Ultrasound-guided Suprascapular Nerve Block and Axillary Nerve Block in Relieving Postoperative Pain After Arthroscopic Rotator Cuff Repair
Anticipated Study Start Date :
Sep 18, 2023
Anticipated Primary Completion Date :
Sep 18, 2025
Anticipated Study Completion Date :
Sep 20, 2025

Arms and Interventions

Arm Intervention/Treatment
Experimental: 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

Procedure: 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.
Other Names:
  • a low fixed dose patient controlled analgesia (PCA)

    		•
    Placebo Comparator: 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

    Procedure: 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.
    Other Names:
  • a low fixed dose patient controlled analgesia (PCA)

    		•

    Outcome Measures

    Primary Outcome Measures

    1. visual analog pain scale (VAS) [preoperative, postoperative 1, 3, 6, 12, 18, 24, 36, 48 hour(s)]

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

    Secondary Outcome Measures

    1. Patient's satisfaction (SAT) [preoperative, postoperative 1, 3, 6, 12, 18, 24, 36, 48 hour(s)]

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

    2. plasma Cortisol [preoperative, postoperative 1, 6, 12, 24, 48 hour(s)]

      ng/mL

    3. IL-6 [preoperative, postoperative 1, 6, 12, 24, 48 hour(s)]

      pg/mL

    4. IL-8 [preoperative, postoperative 1, 6, 12, 24, 48 hour(s)]

      pg/mL

    5. IL-1β [preoperative, postoperative 1, 6, 12, 24, 48 hour(s)]

      pg/mL

    6. Substance P [preoperative, postoperative 1, 6, 12, 24, 48 hour(s)]

      pg/mL

    7. Serotonin [preoperative, postoperative 1, 6, 12, 24, 48 hour(s)]

      ng/mL

    8. β -endorphin [preoperative, postoperative 1, 6, 12, 24, 48 hour(s)]

      pg/mL

    9. norepinephrine [preoperative, postoperative 1, 6, 12, 24, 48 hour(s)]

      pg/mL

    Eligibility Criteria

    Criteria

    Ages Eligible for Study:
    20 Years and Older
    Sexes Eligible for Study:
    All
    Accepts Healthy Volunteers:
    No
    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.

    Contacts and Locations

    Locations

    No locations specified.

    Sponsors and Collaborators

    • Chuncheon Sacred Heart Hospital
    • Hallym University Medical Center

    Investigators

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

    Study Documents (Full-Text)

    None provided.

    More Information

    Publications

    None provided.
    Responsible Party:
    Jung-Taek Hwang, Professor, Chuncheon Sacred Heart Hospital
    ClinicalTrials.gov Identifier:
    NCT06055478
    Other Study ID Numbers:
    • 2023-07-017-001
    First Posted:
    Sep 26, 2023
    Last Update Posted:
    Sep 26, 2023
    Last Verified:
    Sep 1, 2023
    Individual Participant Data (IPD) Sharing Statement:
    No
    Plan to Share IPD:
    No
    Studies a U.S. FDA-regulated Drug Product:
    No
    Studies a U.S. FDA-regulated Device Product:
    No
    Keywords provided by Jung-Taek Hwang, Professor, Chuncheon Sacred Heart Hospital
    suprascapular nerve block(SSNB)
    axillary nerve block(ANB)
    visual analog pain scale(VAS)
    patient's satisfaction(SAT)
    pain related cytokines
    arthroscopic rotator cuff repair
    Additional relevant MeSH terms:
    Rotator Cuff Injuries

    Study Results

    No Results Posted as of Sep 26, 2023