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

Regional Anesthesia Clinical Trial

Official title:

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT03679897
• Other study ID #: 2018-1117
• Status: Completed
• Phase: Phase 4
• Start date: September 18, 2018
• Est. completion date: December 8, 2018

Study information

• Verified date: December 2018
• Source: Asan Medical Center
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 46
• Est. completion date: December 8, 2018
• Est. primary completion date: December 7, 2018
• Accepts healthy volunteers: No
• Gender: All
• Age group: 19 Years to 80 Years

Eligibility

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

Related Conditions & MeSH terms

• Regional Anesthesia

Intervention

Drug:
• Ropivacaine solution
ultrasound-guided infraclavicular brachial plexus block with 0.375% ropivacaine solution
• Levobupivacaine solution
ultrasound-guided infraclavicular brachial plexus block with 0.25% levobupivacaine solution

Locations

Country	Name	City	State
Korea, Republic of	Asan Medical Center	Seoul

Sponsors (1)

Lead Sponsor	Collaborator
Asan Medical Center

Country where clinical trial is conducted

Korea, Republic of, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	onset time of sensory block	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	up to 40 minutes
Secondary	onset time of motor block	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	up to 40 minutes
Secondary	duration of analgesia	defined as time for first request by the patient	24 hours