Rotator Cuff Tears
Conditions
Keywords
suprascapular nerve block(SSNB), axillary nerve block(ANB), visual analog pain scale(VAS), patient's satisfaction(SAT), pain related cytokines, arthroscopic rotator cuff repair
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.
Interventions
PROCEDUREPreemptive 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.
Sponsors
Chuncheon Sacred Heart Hospital
Hallym University Medical Center
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 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
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 |
|---|---|---|
| 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 |
| 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 |
| Substance P | preoperative, postoperative 1, 6, 12, 24, 48 hour(s) | pg/mL |
| 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 |
Countries
South Korea
Contacts
PRINCIPAL_INVESTIGATORJung-Taek Hwang, MD,PhD
Hallym University Medical Center
Outcome results
None listed