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Comparison of 0.375% Ropivacaine and 0.25% Levobupivacaine for Infraclavicular Brachial Plexus Block

NCT ID: NCT03679897

Last Updated: 2018-12-20

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

COMPLETED

Clinical Phase

PHASE4

Total Enrollment

46 participants

Study Classification

INTERVENTIONAL

Study Start Date

2018-09-18

Study Completion Date

2018-12-08

Brief Summary

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Infraclavicular brachial plexus block has been used more frequently with the development of high-resolution ultrasound. Compared with peripheral nerve block using landmark technique or nerve stimulator technique, ultrasound-guided peripheral nerve block decreases the required dose of local anesthetics. As the dose of the drug used decreases, the systemic toxic effects of local anesthetics are reduced. However, the decreased dose of the drugs might have influence on the onset time of local anesthetics. Thus, the investigator aimed to evaluated the onset time of the two equipotent local anesthetics, 0.375% ropivacaine and 0.25% levobupivacaine.

Detailed Description

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Conditions

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Regional Anesthesia

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

Primary Study Purpose

TREATMENT

Blinding Strategy

DOUBLE

Participants Investigators

Study Groups

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Ropivacaine group

BPB with 0.375% ropivacaine solution

Group Type EXPERIMENTAL

Ropivacaine solution

Intervention Type DRUG

ultrasound-guided infraclavicular brachial plexus block with 0.375% ropivacaine solution

Levobupivacaine group

BPB with 0.25% levobupivacaine solution

Group Type ACTIVE_COMPARATOR

Levobupivacaine solution

Intervention Type DRUG

ultrasound-guided infraclavicular brachial plexus block with 0.25% levobupivacaine solution

Interventions

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Ropivacaine solution

ultrasound-guided infraclavicular brachial plexus block with 0.375% ropivacaine solution

Intervention Type DRUG

Levobupivacaine solution

ultrasound-guided infraclavicular brachial plexus block with 0.25% levobupivacaine solution

Intervention Type DRUG

Other Intervention Names

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rop levo

Eligibility Criteria

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Inclusion Criteria

* American Society of Anesthesiologists physical status 1-3
* Patients undergoing upper extremity surgery with infraclavicular brachial plexus block

Exclusion Criteria

* Patients who do not agree to participate in clinical trial
* Patients presenting with neurological deficits of the upper arm, severe coagulopathy, chronic renal failure, cardiopulmonary compromise, cerebral vascular disease, hypersensitivity to hyaluronidase or local anesthetics or local infection at the site of the infraclavicular block, pregnancy
Minimum Eligible Age

19 Years

Maximum Eligible Age

80 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No

Sponsors

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Asan Medical Center

OTHER

Sponsor Role lead

Responsible Party

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Hajung Kim

Clinical Instructor

Responsibility Role PRINCIPAL_INVESTIGATOR

Principal Investigators

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Won Uk Koh, M.D., Ph.D.

Role: PRINCIPAL_INVESTIGATOR

University of Ulsan, College of Medicine, Asan Medical Center

Locations

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Asan Medical Center

Seoul, , South Korea

Site Status

Countries

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South Korea

References

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Kim HJ, Lee S, Chin KJ, Kim JS, Kim H, Ro YJ, Koh WU. Comparison of the onset time between 0.375% ropivacaine and 0.25% levobupivacaine for ultrasound-guided infraclavicular brachial plexus block: a randomized-controlled trial. Sci Rep. 2021 Feb 25;11(1):4703. doi: 10.1038/s41598-021-84172-2.

Reference Type DERIVED
PMID: 33633231 (View on PubMed)

Other Identifiers

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2018-1117

Identifier Type: -

Identifier Source: org_study_id