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

NCT ID: NCT05691101

Last Updated: 2023-02-02

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

UNKNOWN

Clinical Phase

NA

Total Enrollment

80 participants

Study Classification

INTERVENTIONAL

Study Start Date

2023-01-31

Study Completion Date

2023-12-31

Brief Summary

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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

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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

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

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

Primary Study Purpose

SUPPORTIVE_CARE

Blinding Strategy

NONE

Study Groups

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Continuous interscalene brachial plexus block(CISB) with IV PCA group

Patients in this group received continuous interscalene brachial plexus block(CISB) and intravenous PCA

Group Type EXPERIMENTAL

CISB with IV PCA group

Intervention Type OTHER

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.

Continuous interscalene brachial plexus block (CISB) group

Patients in this group received continuous interscalene brachial plexus block (CISB)

Group Type ACTIVE_COMPARATOR

CISB group

Intervention Type OTHER

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.

Interventions

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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.

Intervention Type 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.

Intervention Type OTHER

Eligibility Criteria

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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
Minimum Eligible Age

20 Years

Maximum Eligible Age

69 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No

Sponsors

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Seoul National University Bundang Hospital

OTHER

Sponsor Role lead

Responsible Party

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Ji In Park

Principal Investigator

Responsibility Role PRINCIPAL_INVESTIGATOR

Principal Investigators

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JI IN PARK

Role: PRINCIPAL_INVESTIGATOR

Seoul National University Bundang Hospital

Locations

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Seoul national univercity Bundang Hospital

Seongnam-si, Gyeonggi-do, South Korea

Site Status RECRUITING

Countries

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South Korea

Central Contacts

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JI IN PARK

Role: CONTACT

82 10 3077 3666

Facility Contacts

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Ji In Park

Role: primary

Other Identifiers

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B-2210/789-001

Identifier Type: -

Identifier Source: org_study_id

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