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OpenTrials
Completed

NCT Number: NCT03679897

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

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.

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Key information

Conditions

Regional Anesthesia

Age range

19 year–80 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Phase 4

Primary location

Asan Medical Center

Seoul, 05505, South Korea

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

Ropivacaine solution

Drug

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

Other names: rop

Levobupivacaine solution

Drug

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

Other names: levo

Primary outcomes

  1. onset time of sensory block

    Time frame: 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 outcomes

  1. onset time of motor block

    Time frame: 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

  2. duration of analgesia

    Time frame: 24 hours

    defined as time for first request by the patient

Sponsors and collaborators

Lead sponsor

Asan Medical Center

Other

Registry information

Official study title

0.25% Levobupivacaine Versus 0.375% Ropivacaine: a Comparative Study in Ultrasound-Guided Infraclavicular Brachial Plexus Block

Important dates

Study start
2018
Primary completion
2018
Study completion
2018
First posted
Sep 21, 2018
Registry last updated
Dec 20, 2018

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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