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

Phase 4

Completed

• Conditions: Regional Anesthesia
• Interventions: Drug: Levobupivacaine solution; Drug: Ropivacaine solution

• Registration Number: NCT03679897
• Lead Sponsor: Asan Medical Center

Brief Summary

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

Not available

Study Timeline

• Study Start: 2018-09-18
• Study First Submitted: 2018-09-19
• Study First Submitted QC: 2018-09-19
• Study First Posted: 2018-09-21
• Status Verified: 2018-12
• Primary Completion: 2018-12-07
• Study Completion: 2018-12-08
• Last Update Submitted: 2018-12-19
• Last Update Posted: 2018-12-20

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 46

Inclusion Criteria

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

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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

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Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
Levobupivacaine group	Levobupivacaine solution	BPB with 0.25% levobupivacaine solution
Ropivacaine group	Ropivacaine solution	BPB with 0.375% ropivacaine solution

Primary Outcome Measures

Name	Time	Method
onset time of sensory block	up to 40 minutes	sensory block of 4 nerves(radial, median, ulnar, musculocutaneous nerve) was assessed with pin-prick test every 5 minutes till 40 minutes from the completion of drug injection

Secondary Outcome Measures

Name	Time	Method
duration of analgesia	24 hours	defined as time for first request by the patient
onset time of motor block	up to 40 minutes	motor block of 4 nerves(radial, median, ulnar, musculocutaneous nerve) was assessed with movement of fingers and elbow every 5 minutes till 40 minutes from the completion of drug injection

Trial Locations

Locations (1)

Asan Medical Center; 🇰🇷 Seoul, Korea, Republic of