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
Trial Snapshot
- Phase
- Not Applicable
- Status
- Recruiting
- Enrollment
- 80
- Locations
- 1
- Primary Endpoint
- Korean version of the Quality of Recovery-15 questionnaire (QoR-15K) score (0-150, 0: poor recovery, 150: good recovery)
Study Overview
Brief Summary
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
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.
Study Design
- Study Type
- Interventional
- Allocation
- Randomized
- Intervention Model
- Parallel
- Primary Purpose
- Supportive Care
- Masking
- None
Eligibility Criteria
- Ages
- 20 Years to 69 Years (Adult, Older Adult)
- Sex
- All
- Accepts Healthy Volunteers
- No
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
Arms & Interventions
Continuous interscalene brachial plexus block(CISB) with IV PCA group
Patients in this group received continuous interscalene brachial plexus block(CISB) and intravenous PCA
Intervention: CISB with IV PCA group (Other)
Continuous interscalene brachial plexus block (CISB) group
Patients in this group received continuous interscalene brachial plexus block (CISB)
Intervention: CISB group (Other)
Outcomes
Primary Outcomes
Korean version of the Quality of Recovery-15 questionnaire (QoR-15K) score (0-150, 0: poor recovery, 150: good recovery)
Time Frame: Postoperative 24 hour
Patient recovery measured by QoR-15K score
Secondary Outcomes
- Pain score(Postoperative 6, 24, 48 hour)
- Cumulative consumption of PCA and rescue analgesics(Postoperative 24, 48 hour)
- Occurrence of adverse effects(Postoperative 24, 48 hour)
Investigators
Ji In Park
Principal Investigator
Seoul National University Bundang Hospital