Regional AnesthesiaPhase 4NCT03679897
Comparison of 0.375% Ropivacaine and 0.25% Levobupivacaine for Infraclavicular Brachial Plexus Block
A Phase 4 study testing Ropivacaine solution and Levobupivacaine solution in people with Regional Anesthesia, run by Asan Medical Center at 1 site in South Korea.
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. Read more about this study
- Who is it for?
- Ages 19 to 80 years
- Conditions the study is for
- Regional Anesthesia
- What is being tested?
- Ropivacaine solution and Levobupivacaine solution
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 46 participants
- Where
- 1 siteSouth Korea
- Study dates
- 18 Sep 2018to 8 Dec 2018
- Phase
- Phase 4
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 19 to 80 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- American Society of Anesthesiologists physical status 1-3
- Patients undergoing upper extremity surgery with infraclavicular brachial plexus block
Who cannot join
- 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
Trial locations and contacts
1 site in 1 country.
About this study
Official title: 0.25% Levobupivacaine Versus 0.375% Ropivacaine: a Comparative Study in Ultrasound-Guided 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.
- Conditions
- Regional Anesthesia
- Being tested
- Ropivacaine solution, Levobupivacaine solution
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Ropivacaine solutionDrug
Also called rop
ultrasound-guided infraclavicular brachial plexus block with 0.375% ropivacaine solution
Levobupivacaine solutionDrug
Also called levo
ultrasound-guided infraclavicular brachial plexus block with 0.25% levobupivacaine solution
| Study group | Role | What they receive |
|---|---|---|
| Ropivacaine group | Experimental | BPB with 0.375% ropivacaine solution Receives: Drug: Ropivacaine solution |
| Levobupivacaine group | Active comparator | BPB with 0.25% levobupivacaine solution Receives: Drug: Levobupivacaine solution |
What is being measured
The primary outcome is the main question the study is designed to answer.
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
Measured: up to 40 minutes
Secondary outcomes (2)
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
Measured: up to 40 minutes
duration of analgesia
defined as time for first request by the patient
Measured: 24 hours
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted21 Sep 2018
- Study start18 Sep 2018
- Primary completion7 Dec 2018
- Study completion8 Dec 2018
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (1)Papers the sponsor has linked to this study.
- Other trials for Regional AnesthesiaStudies of the same condition, open and under way.
- More trials run by Asan Medical CenterThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase 4
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Double blind
- Who is masked
- Participant, Investigator
- Enrolment
- 46 participants (actual)
Sponsor and investigators
- Lead sponsor
- Asan Medical Center
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Hajung Kim, Asan Medical Center
- Investigators
- Won Uk Koh, M.D., Ph.D., Principal investigator, University of Ulsan, College of Medicine, Asan Medical Center
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT03679897
- Sponsor's protocol ID
- 2018-1117
- Status last verified
- Dec 2018
- First submitted
- 19 Sep 2018
- Last updated
- 20 Dec 2018
- Results posted
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
Publications
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.
PubMed 33633231
Study at a glance
From the registry record, last updated by the sponsor on 20 Dec 2018. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- 0.25% Levobupivacaine Versus 0.375% Ropivacaine: a Comparative Study in Ultrasound-Guided Infraclavicular Brachial Plexus Block
- ClinicalTrials.gov ID
- NCT03679897
- Acronym / sponsor ID
- 2018-1117
- Conditions
- Regional Anesthesia
- Phase
- Phase 4
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 46 participants (actual)
- Lead sponsor
- Asan Medical CenterUniversity, hospital or other
- Study start
- 18 Sep 2018 (actual)
- Primary completion
- 7 Dec 2018 (actual)
- Study completion
- 8 Dec 2018 (actual)
- First posted
- 21 Sep 2018 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Double blind (participant, investigator)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Ropivacaine group | Experimental | Drug: Ropivacaine solutionBPB with 0.375% ropivacaine solution |
| Levobupivacaine group | Active comparator | Drug: Levobupivacaine solutionBPB with 0.25% levobupivacaine solution |
Who may qualify
- Ages
- 19 to 80 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (2 listed)
- American Society of Anesthesiologists physical status 1-3
- Patients undergoing upper extremity surgery with infraclavicular brachial plexus block
Key exclusion criteria (2 listed)
- 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
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Ropivacaine solutionAlso: ropultrasound-guided infraclavicular brachial plexus block with 0.375% ropivacaine solution | Drug | Ropivacaine group |
| Levobupivacaine solutionAlso: levoultrasound-guided infraclavicular brachial plexus block with 0.25% levobupivacaine solution | Drug | Levobupivacaine group |
Primary outcome
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
2 secondary outcomes
onset time of motor block
Time frame: up to 40 minutes
duration of analgesia
Time frame: 24 hours
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 20 Dec 2018.
- Derived from this study: PubMed 33633231Kim 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.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Won Uk Koh, M.D., Ph.D. principal investigator
University of Ulsan, College of Medicine, Asan Medical Center
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 4 study testing Ropivacaine solution and Levobupivacaine solution in people with Regional Anesthesia, run by Asan Medical Center at 1 site in South Korea.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 2 inclusion and 2 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 20 Dec 2018. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in South Korea. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
What does this phase mean?
Phase 4 studies take place after a treatment is approved, to learn more about its long-term benefits and risks in everyday use.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
onset time of sensory block (time frame: up to 40 minutes). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT03679897, which also lists 1 linked publication.
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 20 Dec 2018; AzTrials last refreshed its copy on 8 Nov 2026.