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

Brachial Plexus Block Clinical Trial

Official title:

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

Clinical Trial Details — Status: Recruiting

Administrative data

• NCT number: NCT05691101
• Other study ID #: B-2210/789-001
• Status: Recruiting
• Phase: N/A
• 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
• 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

Related Conditions & MeSH terms

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

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