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Clinical Trial Details — Status: Recruiting

Administrative data

NCT number NCT06055478
Other study ID # 2023-07-017-001
Secondary ID
Status Recruiting
Phase N/A
First received
Last updated
Start date September 25, 2023
Est. completion date September 20, 2025

Study information

Verified date October 2023
Source Chuncheon Sacred Heart Hospital
Contact Jung-Taek Hwang, MD, PhD
Phone +82332405197
Email DRAKEHJT@HANMAIL.NET
Is FDA regulated No
Health authority
Study type Interventional

Clinical Trial 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.


Recruitment information / eligibility

Status Recruiting
Enrollment 100
Est. completion date September 20, 2025
Est. primary completion date September 18, 2025
Accepts healthy volunteers No
Gender All
Age group 20 Years and older
Eligibility 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.

Study Design


Related Conditions & MeSH terms


Intervention

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.

Locations

Country Name City State
Korea, Republic of Jung-Taek Hwang Chuncheon Gangwon

Sponsors (2)

Lead Sponsor Collaborator
Chuncheon Sacred Heart Hospital Hallym University Medical Center

Country where clinical trial is conducted

Korea, Republic of, 

References & Publications (2)

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):9 — View Citation

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 cu — View Citation

Outcome

Type Measure Description Time frame Safety issue
Primary visual analog pain scale (VAS) 0-10, 0: no pain, 10: very severe pain preoperative, postoperative 1, 3, 6, 12, 18, 24, 36, 48 hour(s)
Secondary Patient's satisfaction (SAT) 0-10, 0: not satisfied, 10: very much satisfied preoperative, postoperative 1, 3, 6, 12, 18, 24, 36, 48 hour(s)
Secondary plasma Cortisol ng/mL preoperative, postoperative 1, 6, 12, 24, 48 hour(s)
Secondary IL-6 pg/mL preoperative, postoperative 1, 6, 12, 24, 48 hour(s)
Secondary IL-8 pg/mL preoperative, postoperative 1, 6, 12, 24, 48 hour(s)
Secondary IL-1ß pg/mL preoperative, postoperative 1, 6, 12, 24, 48 hour(s)
Secondary Substance P pg/mL preoperative, postoperative 1, 6, 12, 24, 48 hour(s)
Secondary Serotonin ng/mL preoperative, postoperative 1, 6, 12, 24, 48 hour(s)
Secondary ß -endorphin pg/mL preoperative, postoperative 1, 6, 12, 24, 48 hour(s)
Secondary norepinephrine pg/mL preoperative, postoperative 1, 6, 12, 24, 48 hour(s)
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