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

Not Applicable

Recruiting

• Conditions: Arthroscopic Rotator Cuff Repair; Brachial Plexus Block; Analgesia, Patient-Controlled
• Interventions: Other: CISB with IV PCA group; Other: CISB group

• Registration Number: NCT05691101
• Lead Sponsor: Seoul National University Bundang Hospital

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 Timeline

• Status Verified: 2023-01
• Study First Submitted: 2023-01-10
• Study First Submitted QC: 2023-01-10
• Study First Posted: 2023-01-19
• Study Start: 2023-01-31
• Last Update Submitted: 2023-01-31
• Last Update Posted: 2023-02-02
• Primary Completion: 2023-12-31
• Study Completion: 2023-12-31

Recruitment & Eligibility

• Status: RECRUITING
• Sex: All
• Target Recruitment: 80

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

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
Continuous interscalene brachial plexus block(CISB) with IV PCA group	CISB with IV PCA group	Patients in this group received continuous interscalene brachial plexus block(CISB) and intravenous PCA
Continuous interscalene brachial plexus block (CISB) group	CISB group	Patients in this group received continuous interscalene brachial plexus block (CISB)

Primary Outcome Measures

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

Secondary Outcome Measures

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

Trial Locations

Locations (1)

Seoul national univercity Bundang Hospital; 🇰🇷 Seongnam-si, Gyeonggi-do, Korea, Republic of