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Recruiting NCT06878391

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No phase Interventional Rotator Cuff Tear

For patients and families

In plain language

An automatic summary of structured registry data. It is an orientation aid, not a substitute for the official protocol or a physician assessment.

What is being studied
The protocol lists: Preemptive ultrasound-guided interscalene brachial plexus block and suprascapular nerve block and axillary nerve block.
Who it may be relevant to
Registry conditions: Rotator Cuff Tear. Basic parameters: from 20 years · All.
What needs checking
Age, condition and sex are only basic indicators. Prior treatment, laboratory values and other mandatory requirements appear in the eligibility criteria below.
Where it takes place
South Korea
Next step
Save the trial, show it to the treating physician, and confirm current recruitment with the study center. Costs, documents and travel →

Unsure about the terms? Read our patient guide →

Official title

A Study on the Pain Control Effects of Interscalene Brachial Plexus Block Combined With Suprascapular Nerve Block and Axillary Nerve Block in Ar-throscopic Rotator Cuff Repair: a Randomized Controlled Trial

Overview

This study is a prospective, randomized, double-blind trial comparing patients who underwent arthroscopic rotator cuff repair and received an interscalene brachial plexus block (9 ml of 0.75% ropivacaine, 3 ml for each trunk) combined with suprascapular nerve block and axillary nerve block (each with 10 ml of 0.75% ropivacaine) versus those who received an interscalene brachial plexus block (9 ml of 0.75% ropivacaine, 3 ml for each trunk) combined with placebo suprascapular and axillary nerve blocks (each with 10 ml of 0.9% saline). The study will compare subjective pain scores (VAS score) and patient satisfaction preoperatively and at 1, 3, 6, 12, 18, 24, 36, and 48 hours postoperatively. Additionally, 5 ml of venous blood will be collected preoperatively and at 1, 6, 12, 24, and 48 hours postoperatively to analyze and compare serum levels of cortisol, IL-6, IL-8, IL-1β, substance P, serotonin, β-endorphin, and norepinephrine.

Interventions

  • Procedure Preemptive ultrasound-guided interscalene brachial plexus block and suprascapular nerve block and axillary nerve block
    Preemptive ultrasound-guided interscalene brachial plexus block using ropivacaine, and 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 measures

  • visual analog pain scale (VAS) [Time frame: preoperative, postoperative 1, 3, 6, 12, 18, 24, 36, 48 hour(s)]
Secondary outcome measures (9)
  • Patient's satisfaction (SAT) [Time frame: preoperative, postoperative 1, 3, 6, 12, 18, 24, 36, 48 hour(s)]
  • plasma Cortisol [Time frame: preoperative, postoperative 1, 6, 12, 24, 48 hour(s)]
  • IL-6 [Time frame: preoperative, postoperative 1, 6, 12, 24, 48 hour(s)]
  • IL-8 [Time frame: preoperative, postoperative 1, 6, 12, 24, 48 hour(s)]
  • IL-1β [Time frame: preoperative, postoperative 1, 6, 12, 24, 48 hour(s)]
  • Substance P [Time frame: preoperative, postoperative 1, 6, 12, 24, 48 hour(s)]
  • Serotonin [Time frame: preoperative, postoperative 1, 6, 12, 24, 48 hour(s)]
  • β -endorphin [Time frame: preoperative, postoperative 1, 6, 12, 24, 48 hour(s)]
  • norepinephrine [Time frame: preoperative, postoperative 1, 6, 12, 24, 48 hour(s)]

Eligibility criteria

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.

Criteria are shown verbatim from the registry (in English). Final eligibility is always assessed by the study center.

Healthy volunteers: No

Study design

Allocation
Randomized
Model
Parallel assignment
Masking
Quadruple blind
Primary purpose
Supportive care

Study locations

South Korea · 2 centers
  • Hallym University Chuncheon Sacred Heart Hospital — Chuncheon
  • Hallym University Chuncheon Sacred Heart Hospital — Chuncheon

Publications

  • 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 24880194
  • 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 32975624

Identifiers

NCT: NCT06878391 · 2024-12-010-003

Primary sources (government registries)

View this study on ClinicalTrials.gov ↗