NCT05691101

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

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

• Status: Unknown
• Phase: N/A
• Study type: Interventional
• Enrollment: 80 (estimated)
• Sponsor: Seoul National University Bundang Hospital · Academic / Other
• Sex: All
• Age: 20 Years – 69 Years
• Healthy volunteers: Not accepted

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.

Conditions

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

Interventions

Type	Name	Description
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.
OTHER	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.

Timeline

• Start date: 2023-01-31
• Primary completion: 2023-12-31
• Completion: 2023-12-31
• First posted: 2023-01-19
• Last updated: 2023-02-02

Locations

1 site across 1 country: South Korea