NCT06055478

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.

Trial Health

43
At Risk

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Trial has exceeded expected completion date
Enrollment
100

participants targeted

Target at P50-P75 for not_applicable

Timeline
Completed

Started Sep 2023

Typical duration for not_applicable

Geographic Reach
1 country

1 active site

Status
unknown

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

First Submitted

Initial submission to the registry

September 15, 2023

Completed
10 days until next milestone

Study Start

First participant enrolled

September 25, 2023

Completed
1 day until next milestone

First Posted

Study publicly available on registry

September 26, 2023

Completed
2 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

September 18, 2025

Completed
2 days until next milestone

Study Completion

Last participant's last visit for all outcomes

September 20, 2025

Completed
Last Updated

October 4, 2023

Status Verified

October 1, 2023

Enrollment Period

2 years

First QC Date

September 15, 2023

Last Update Submit

October 3, 2023

Conditions

Rotator Cuff Tears

Keywords

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

Outcome Measures

Primary Outcomes (1)

  • 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 Outcomes (9)

  • Patient's satisfaction (SAT)

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

  • plasma Cortisol

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

  • IL-6

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

  • IL-8

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

  • IL-1β

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

  • +4 more secondary outcomes

Study Arms (2)

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

EXPERIMENTAL

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 saline

PLACEBO COMPARATOR

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

Interventions

Preemptive ultrasound-guided suprascapular nerve block and axillary nerve blockPROCEDURE

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.

Also known as: a low fixed dose patient controlled analgesia (PCA)
Preemptive ultrasound-guided suprascapular nerve block and axillary nerve block using ropivacainePreemptive ultrasound-guided suprascapular nerve block and axillary nerve block using saline

Eligibility Criteria

Age20 Years+
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • 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

You may not qualify if:

  • 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.

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Jung-Taek Hwang

Chuncheon, Gangwon-do, 24253, South Korea

RECRUITING

Related Publications (2)

  • 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.

    PMID: 32975624RESULT

  • 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.

    PMID: 24880194RESULT

MeSH Terms

Conditions

Rotator Cuff Injuries

Interventions

Analgesia, Patient-Controlled

Condition Hierarchy (Ancestors)

RuptureWounds and InjuriesShoulder InjuriesTendon Injuries

Intervention Hierarchy (Ancestors)

AnalgesiaAnesthesia and Analgesia

Study Officials

  • Jung-Taek Hwang, MD,PhD

    Hallym University Medical Center

    PRINCIPAL INVESTIGATOR

Central Study Contacts

Jung-Taek Hwang, MD, PhD

CONTACT

+82332405197DRAKEHJT@HANMAIL.NET

Ju Sun Kim

CONTACT

+82332405198wntjs2263@naver.com

Study Design

Study Type
interventional
Phase
not applicable
Allocation
RANDOMIZED
Masking
QUADRUPLE
Who Masked
PARTICIPANT, CARE PROVIDER, INVESTIGATOR, OUTCOMES ASSESSOR
Masking Details
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.
Purpose
SUPPORTIVE CARE
Intervention Model
PARALLEL
Model Details: 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
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
Professor

Study Record Dates

First Submitted

September 15, 2023

First Posted

September 26, 2023

Study Start

September 25, 2023

Primary Completion

September 18, 2025

Study Completion

September 20, 2025

Last Updated

October 4, 2023

Record last verified: 2023-10

Data Sharing

IPD Sharing
Will not share

We can decide it after the termination of this study.

Locations

KR(1)