ISB With SSNB & ANB
ConditionRotator Cuff Tear
Trial statusRecruiting
Trial phaseNot applicable
Trial typeInterventional
Biological sexAll
Age20+
SponsorChuncheon Sacred Heart Hospital
About this trial
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.
Eligibility criteria
This trial does not accept healthy volunteersQualifiers
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
Disqualifiers
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
Trial design
Design model
Parallel
Treatments tested in this trial
Preemptive ultrasound-guided interscalene brachial plexus block and suprascapular nerve block and axillary nerve block
Procedure/SurgeryPreemptive 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.
Treatment groups
100 Participants
are divided into 2 treatment groupsGroup A: ISB with SSNB & ANBExperimental treatment 1 intervention
Group B: ISB with placebo SSNB & ANBPlacebo comparator 1 intervention
Trial outcomes
Primary outcomes
1
visual analog pain scale (VAS)
0-10, 0: no pain, 10: very severe pain
Time frame
preoperative, postoperative 1, 3, 6, 12, 18, 24, 36, 48 hour(s)Secondary outcomes
1
Patient's satisfaction (SAT)
0-10, 0: not satisfied, 10: very much satisfied
Time frame
preoperative, postoperative 1, 3, 6, 12, 18, 24, 36, 48 hour(s)2
plasma Cortisol
ng/mL
Time frame
preoperative, postoperative 1, 6, 12, 24, 48 hour(s)3
IL-6
pg/mL
Time frame
preoperative, postoperative 1, 6, 12, 24, 48 hour(s)4
IL-8
pg/mL
Time frame
preoperative, postoperative 1, 6, 12, 24, 48 hour(s)Sponsors and contacts
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Source ClinicalTrials.gov