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Clinical Trial Details — Status: Recruiting

Administrative data

NCT number NCT05691101
Other study ID # B-2210/789-001
Secondary ID
Status Recruiting
Phase N/A
First received
Last updated
Start date January 31, 2023
Est. completion date December 31, 2023

Study information

Verified date January 2023
Source Seoul National University Bundang Hospital
Contact JI IN PARK
Phone 82 10 3077 3666
Email monica0120120@gmail.com
Is FDA regulated No
Health authority
Study type Interventional

Clinical Trial 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.


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.


Recruitment information / eligibility

Status Recruiting
Enrollment 80
Est. completion date December 31, 2023
Est. primary completion date December 31, 2023
Accepts healthy volunteers No
Gender All
Age group 20 Years to 69 Years
Eligibility 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

Study Design


Intervention

Other:
CISB with IV PCA group
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.
CISB group
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.

Locations

Country Name City State
Korea, Republic of Seoul national univercity Bundang Hospital Seongnam-si Gyeonggi-do

Sponsors (1)

Lead Sponsor Collaborator
Seoul National University Bundang Hospital

Country where clinical trial is conducted

Korea, Republic of, 

Outcome

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