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

NCT03679897 | Completed Phase 4

• 1 other identifier: 2018-1117
• Study Type: interventional
• Target: 46
• Locations: 1 country
• Sites: 1

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.

Conditions

Regional Anesthesia

Outcome Measures

Primary Outcomes (1)

• 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 Outcomes (2)

• onset time of motor block

  up to 40 minutes

• duration of analgesia

  24 hours

Study Arms (2)

Ropivacaine group

EXPERIMENTAL

BPB with 0.375% ropivacaine solution

Drug: Ropivacaine solution

Levobupivacaine group

ACTIVE COMPARATOR

BPB with 0.25% levobupivacaine solution

Drug: Levobupivacaine solution

Interventions

Ropivacaine solution DRUG

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

Also known as: rop

Ropivacaine group

Levobupivacaine solution DRUG

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

Also known as: levo

Levobupivacaine group

Eligibility Criteria

• Age: 19 Years - 80 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

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

You may not qualify if:

• 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

Sponsors & Collaborators

• Asan Medical Center: lead

Study Sites (1)

Asan Medical Center

Seoul, 05505, South Korea

Location

Related Publications (1)

• 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.

  PMID: 33633231 DERIVED

Study Officials

• Won Uk Koh, M.D., Ph.D.

  University of Ulsan, College of Medicine, Asan Medical Center

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: phase 4
• Allocation: RANDOMIZED
• Masking: DOUBLE
• Who Masked: PARTICIPANT, INVESTIGATOR
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Clinical Instructor

Study Record Dates

• First Submitted: September 19, 2018
• First Posted: September 21, 2018
• Study Start: September 18, 2018
• Primary Completion: December 7, 2018
• Study Completion: December 8, 2018
• Last Updated: December 20, 2018

Record last verified: 2018-12

Locations

KR (1)