Motion SicknessPhase 4ED90NCT06587386
The Minimum Effective Dose (ED90) of Liposomal Bupivacaine for Preserving Motor Function
A Phase 4 study testing First patient Bupivacaine liposome and next patient Bupivacaine liposome in people with Motion Sickness, run by Affiliated Hospital of Jiaxing University at 1 site in China.
Trial summary
Explore the minimum effective dose of liposomal bupivacaine for preserving motor function Read more about this study
- Who is it for?
- Ages 41 to 65 years
- Conditions the study is for
- Motion Sickness
- What is being tested?
- First patient Bupivacaine liposome and next patient Bupivacaine liposome
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 55 participants
- Where
- 1 siteChina
- Study dates
- 20 May 2025to 10 Nov 2025
- 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 41 to 65 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Age 41-65 years ASA physical condition 1-3 BMI 18-30 kg/m2 undergoing arthroscopic shoulder surgery
Who cannot join
- Inability to consent to the study pregnancy allergy to local anesthetics preexisting neuropathy cervical pathologies (i.e., herniated disc, myelopathy) chronic pain syndromes (defined as reflex sympathetic dystrophy or complex regional pain syndrome) severe respiratory conditions psychiatric or cognitive disorders that prohibit patients from adhering to the study protocol history of drug or alcohol abuse chronic opioid use (longer than 3 months or daily morphine equivalents more than 5mg/day for 1 month) contraindication for general anesthesia and/or interscalene nerve block and planned open shoulder arthrotomies Muscle related diseases
Trial locations and contacts
1 site in 1 country.
About this study
Official title: The Minimum Effective Dose (ED90) of Liposomal Bupivacaine for Preserving Motor Function After Interscalene Brachial Plexus Block: a Dose-finding Study
Explore the minimum effective dose of liposomal bupivacaine for preserving motor function
Read the detailed description
Our research group plans to conduct a dose exploration experiment, using a biased coin design sequential method to explore the 90% minimum effective dose of bupivacaine liposomes for preserving motor function after intermuscular groove brachial plexus block surgery in shoulder arthroscopy.
- Conditions
- Motion Sickness
- Being tested
- First patient Bupivacaine liposome and next patient Bupivacaine liposome
- Keywords
- Shoulder surgery, Intermuscular sulcus brachial plexus block, Bupivacaine liposome, Effective dose
- Medical subject headings
- Motion Sickness
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
First patient Bupivacaine liposome and next patient Bupivacaine liposomeDrug
This study was conducted using the biased coin method, where each patient's use of bupivacaine liposome dose depended on the previous patient's response. Based on previous research and our past experience, the first recruited patient used a dose of 66.5mg (15ml). Subsequently, if motor function was preserved, the next patient received a higher dose (increased by 6.65mg) with a probability of b=0.11; or the same dose with a probability of 1-b=0.89. If motor function was blocked, the next patient received a lower dose (decreased by 6.65mg).
| Study group | Role | What they receive |
|---|---|---|
| First patient's dose of bupivacaine liposome | Experimental | First patient's use of bupivacaine liposome and next patient's use of bupivacaine liposome Receives: Drug: First patient Bupivacaine liposome and next patient Bupivacaine liposome |
| next patient's dose of bupivacaine liposome | Experimental | First patient's use of bupivacaine liposome and next patient's use of bupivacaine liposome Receives: Drug: First patient Bupivacaine liposome and next patient Bupivacaine liposome |
What is being measured
The primary outcome is the main question the study is designed to answer.
ED90 of motor function was preserved 72 hours after brachial plexus block
Evaluate the effective sensory blockade for maintaining motor function at the time point
Measured: 72 hours after brachial plexus block
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted19 Sep 2024
- Study start20 May 2025
- Primary completion10 Nov 2025
- Study completion10 Nov 2025
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Motion SicknessStudies of the same condition, open and under way.
- 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
- Diagnosis
- Allocation
- Randomised
- Intervention model
- Sequential
- Masking
- Double blind
- Who is masked
- Participant, Investigator
- Enrolment
- 55 participants (actual)
Sponsor and investigators
- Lead sponsor
- Affiliated Hospital of Jiaxing University
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Qing-he Zhou, Affiliated Hospital of Jiaxing University
- Investigators
- Qinghe Zhou, Study chair, Affiliated Hospital of Jiaxing University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06587386
- Sponsor's protocol ID
- 2024-KY-656-002
- Acronym
- ED90
- Status last verified
- Dec 2025
- First submitted
- 3 Sep 2024
- Last updated
- 29 Dec 2025
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 29 Dec 2025. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- The Minimum Effective Dose (ED90) of Liposomal Bupivacaine for Preserving Motor Function After Interscalene Brachial Plexus Block: a Dose-finding Study
- ClinicalTrials.gov ID
- NCT06587386
- Acronym / sponsor ID
- ED90 / 2024-KY-656-002
- Conditions
- Motion Sickness
- Keywords
- Shoulder surgery, Intermuscular sulcus brachial plexus block, Bupivacaine liposome, Effective dose
- Phase
- Phase 4
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 55 participants (actual)
- Lead sponsor
- Affiliated Hospital of Jiaxing UniversityUniversity, hospital or other
- Study start
- 20 May 2025 (actual)
- Primary completion
- 10 Nov 2025 (actual)
- Study completion
- 10 Nov 2025 (actual)
- First posted
- 19 Sep 2024 (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.
Explore the minimum effective dose of liposomal bupivacaine for preserving motor function
Detailed description
Our research group plans to conduct a dose exploration experiment, using a biased coin design sequential method to explore the 90% minimum effective dose of bupivacaine liposomes for preserving motor function after intermuscular groove brachial plexus block surgery in shoulder arthroscopy.
Study design
- Primary purpose
- Diagnosis
- Allocation
- Randomised
- Intervention model
- Sequential
- Masking
- Double blind (participant, investigator)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| First patient's dose of bupivacaine liposome | Experimental | Drug: First patient Bupivacaine liposome and next patient Bupivacaine liposomeFirst patient's use of bupivacaine liposome and next patient's use of bupivacaine liposome |
| next patient's dose of bupivacaine liposome | Experimental | Drug: First patient Bupivacaine liposome and next patient Bupivacaine liposomeFirst patient's use of bupivacaine liposome and next patient's use of bupivacaine liposome |
Who may qualify
- Ages
- 41 to 65 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (1 listed)
- Age 41-65 years ASA physical condition 1-3 BMI 18-30 kg/m2 undergoing arthroscopic shoulder surgery
Key exclusion criteria (1 listed)
- Inability to consent to the study pregnancy allergy to local anesthetics preexisting neuropathy cervical pathologies (i.e., herniated disc, myelopathy) chronic pain syndromes (defined as reflex sympathetic dystrophy or complex regional pain syndrome) severe respiratory conditions psychiatric or cognitive disorders that prohibit patients from adhering to the study protocol history of drug or alcohol abuse chronic opioid use (longer than 3 months or daily morphine equivalents more than 5mg/day for 1 month) contraindication for general anesthesia and/or interscalene nerve block and planned open shoulder arthrotomies Muscle related diseases
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 |
|---|---|---|
| First patient Bupivacaine liposome and next patient Bupivacaine liposomeThis study was conducted using the biased coin method, where each patient's use of bupivacaine liposome dose depended on the previous patient's response. Based on previous research and our past experience, the first recruited patient used a dose of 66.5mg (15ml). Subsequently, if motor function was preserved, the next patient received a higher dose (increased by 6.65mg) with a probability of b=0.11; or the same dose with a probability of 1-b=0.89. If motor function was blocked, the next patient received a lower dose (decreased by 6.65mg). | Drug | First patient's dose of bupivacaine liposome, next patient's dose of bupivacaine liposome |
Primary outcome
ED90 of motor function was preserved 72 hours after brachial plexus block
Time frame: 72 hours after brachial plexus block
Evaluate the effective sensory blockade for maintaining motor function at the time point
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 29 Dec 2025.
- Individual participant dataSharing planned: No
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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.
Qinghe Zhou study chair
Affiliated Hospital of Jiaxing University
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 First patient Bupivacaine liposome and next patient Bupivacaine liposome in people with Motion Sickness, run by Affiliated Hospital of Jiaxing University at 1 site in China.
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 1 inclusion and 1 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 29 Dec 2025. 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 China. 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?
ED90 of motor function was preserved 72 hours after brachial plexus block (time frame: 72 hours after brachial plexus block). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
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 29 Dec 2025; AzTrials last refreshed its copy on 8 Nov 2026.