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

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.

Study Overview

• Status: Not yet recruiting
• Conditions: Brachial Plexus Block; Analgesia, Patient-Controlled; Arthroscopic Rotator Cuff Repair
• Intervention / Treatment: Other: CISB with IV PCA

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 Type: Interventional
• Enrollment (Anticipated): 80
• Phase: Not Applicable

Contacts and Locations

• Study Contact: Name: JI IN PARK; Phone Number: 82 10 3077 3666; Email: monica0120120@gmail.com

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 20 years to 69 years (Adult, Older Adult)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: All

Description

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 Plan

How is the study designed?

Design Details

• Primary Purpose: Supportive Care
• Allocation: Randomized
• Interventional Model: Parallel Assignment
• Masking: None (Open Label)

Number of Arms

2

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Experimental: Continuous interscalene brachial plexus block(CISB) with IV PCA group; Patients in this group received continuous interscalene brachial plexus block(CISB) and intravenous PCA	Other: CISB with IV PCA; Both 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.; For CISB with IV PCA group; 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.; For CISB group; 0.2 % ropivacaine (4 ml/hour with patient selected bolus 5 ml, lockout 60 minutes) was injected through the continuous brachial plexus block catheter.
Active Comparator: Continuous interscalene brachial plexus block (CISB) group; Patients in this group received continuous interscalene brachial plexus block (CISB)	Other: CISB with IV PCA; Both 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.; For CISB with IV PCA group; 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.; For CISB group; 0.2 % ropivacaine (4 ml/hour with patient selected bolus 5 ml, lockout 60 minutes) was injected through the continuous brachial plexus block catheter.

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
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 Outcome Measures

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

Collaborators and Investigators

• Sponsor: Seoul National University Bundang Hospital
• Investigators: Principal Investigator: JI IN PARK, Seoul National University Bundang Hospital

Study record dates

Study Major Dates

• Study Start (Anticipated): January 12, 2023
• Primary Completion (Anticipated): December 31, 2023
• Study Completion (Anticipated): December 31, 2023

Study Registration Dates

• First Submitted: January 10, 2023
• First Submitted That Met QC Criteria: January 10, 2023
• First Posted (Actual): January 19, 2023

Study Record Updates

• Last Update Posted (Actual): January 23, 2023
• Last Update Submitted That Met QC Criteria: January 19, 2023
• Last Verified: January 1, 2023

More Information

Terms related to this study

• Keywords: Postoperative pain; IV PCA; Continuous interscalene brachial plexus block
• Other Study ID Numbers: B-2210/789-001

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: No

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No