Rotator Cuff Tear
Conditions
Brief summary
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
PROCEDUREPreemptive 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.
Sponsors
Chuncheon Sacred Heart Hospital
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
SUPPORTIVE_CARE
Masking
QUADRUPLE (Subject, Caregiver, 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.
Intervention model description
Study group: Preemptive US guided interscalene brachial plexus block (9ml 0.75% ropivacaine, 3ml for each trunk), and suprascapular nerve block (SSNB) and axillary nerve block (ANB) using each 0.75% ropivacaine 10mL Control group: Preemptive US guided interscalene brachial plexus block (9ml 0.75% ropivacaine, 3ml for each trunk), and suprascapular nerve block (SSNB) and axillary nerve block (ANB) using each 0.9% saline 10mL
Eligibility
Sex/Gender
ALL
Age
20 Years to No maximum
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.
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| 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
| Measure | Time frame | Description |
|---|---|---|
| plasma Cortisol | preoperative, postoperative 1, 6, 12, 24, 48 hour(s) | ng/mL |
| IL-6 | preoperative, postoperative 1, 6, 12, 24, 48 hour(s) | pg/mL |
| IL-8 | preoperative, postoperative 1, 6, 12, 24, 48 hour(s) | pg/mL |
| IL-1β | preoperative, postoperative 1, 6, 12, 24, 48 hour(s) | pg/mL |
| 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 |
| Serotonin | preoperative, postoperative 1, 6, 12, 24, 48 hour(s) | ng/mL |
| β -endorphin | preoperative, postoperative 1, 6, 12, 24, 48 hour(s) | pg/mL |
| norepinephrine | preoperative, postoperative 1, 6, 12, 24, 48 hour(s) | pg/mL |
| Substance P | preoperative, postoperative 1, 6, 12, 24, 48 hour(s) | pg/mL |
Countries
South Korea
Contacts
Primary ContactJung-Taek Hwang, MD, PhD
Backup ContactSu-Jung Seo, PhD
Outcome results
None listed