Comparison of Using CIBPB With or Without IV-PCA After Arthroscopic Rotator Cuff Repair

Study Overview
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Brief Summary
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The goal of this study is to compare the continuous brachial plexus block with or without intravenous patient controlled analgesia(PCA) in patients undergoing arthroscopic rotator cuff repair, in terms of quality of recovery, postoperative pain score, and adverse event.

Detailed Description
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The Bellomic® M silicone balloon infuser, dual continuous petite type (cebika, Uiwang-si, Gyeonggi-do, Republic of Korea) has 2-channel infusion elastomeric pump with two balloon chambers. This structure allows the simultaneous use of continuous nerve block and intravenous PCA. In addition, intravenous PCA can be continued even when continuous nerve block is discontinued due to discomfort such as numbness, tingling sense or motor block. This is expected to contribute to the patient satisfaction and quality of recovery.

Official Title
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Comparison of Quality of Recovery in Patients Using Continuous Brachial Plexus Block With or Without Intravenous Patient-Controlled Analgesia After Arthroscopic Rotator Cuff Repair: A Prospective Randomized Study

Conditions
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Analgesia, Patient-Controlled, Brachial Plexus Block, Arthroscopic Rotator Cuff Repair

Intervention / Treatment
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* Other: CISB with IV PCA group
* Other: CISB group


Participation Criteria
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Eligibility Criteria
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Inclusion Criteria: Having arthroscopic rotator cuff repair American Society of Anesthesiologists physical status I-III Exclusion Criteria: Contraindication to interscalene brachial plexus block Contraindication to fentanyl

Ages Eligible for Study
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Minimum Age: 20 Years
Maximum Age: 69 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Supportive Care
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: None (Open Label)


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: Continuous interscalene brachial plexus block(CISB) with IV PCA group<br>Patients in this group received continuous interscalene brachial plexus block(CISB) and intravenous PCA | Other: CISB with IV PCA group<br>* Ultrasonography guided interscalene brachial plexus block was done with a 5 cm block needle and catheter was inserted. (Stimuplex®A, B Braun Medical, Bethlehem, PA). 10 mL 0.375 % ropivacaine was injected through the catheter. 0.2 % ropivacaine 4 ml/hour was injected through the continuous brachial plexus block catheter. IV-PCA with fentanyl (basal flow 0 ml with patient selected bolus 14 mcg, lockout 10 minutes) was started.<br>|
| Active Comparator: Continuous interscalene brachial plexus block (CISB) group<br>Patients in this group received continuous interscalene brachial plexus block (CISB) | Other: CISB group<br>* Ultrasonography guided interscalene brachial plexus block was done with a 5 cm block needle and catheter was inserted. (Stimuplex®A, B Braun Medical, Bethlehem, PA). 10 mL 0.375 % ropivacaine was injected through the catheter. 0.2 % ropivacaine (4 ml/hour with patient selected bolus 5 ml, lockout 60 minutes) was injected through the continuous brachial plexus block catheter.<br>|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Korean version of the Quality of Recovery-15 questionnaire (QoR-15K) score (0-150, 0: poor recovery, 150: good recovery) | Patient recovery measured by QoR-15K score | Postoperative 24 hour | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Pain score | Numerical Rating Scale (NRS-11(0-10): 0:no Pain and 10:Severe/Worst Pain) | Postoperative 6, 24, 48 hour | 
| Cumulative consumption of PCA and rescue analgesics | Cumulative consumption of systemic analgesics | Postoperative 24, 48 hour | 
| Occurrence of adverse effects | Nausea, vomiting, numbness, tingling sense, motor and sensory blockade | Postoperative 24, 48 hour | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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Postoperative pain, IV PCA, Continuous interscalene brachial plexus block