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CompletedNCT06587386ED90Updated Dec 29, 2025

The Minimum Effective Dose (ED90) of Liposomal Bupivacaine for Preserving Motor Function

A Phase 4 interventional study of First patient Bupivacaine liposome and next patient Bupivacaine liposome in Motion Sickness, sponsored by Affiliated Hospital of Jiaxing University. Completed at 1 site in China. Open to participants aged 41 Years to 65 Years. Per ClinicalTrials.gov, last updated 2025-12-29.

Sponsored by Affiliated Hospital of Jiaxing University · Phase 4, Interventional, and Diagnostic

Phase
Phase 4
Study type
Interventional
Enrollment
55
Allocation
Randomized
Ages
41 Years to 65 Years
Sex
All
01

Study summary

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.

02

Conditions studied

  • Motion Sickness

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Keywords

  • Shoulder surgery
  • Intermuscular sulcus brachial plexus block
  • Bupivacaine liposome
  • Effective dose
03

In context

Motion Sickness

50 studies on the registry are indexed under Motion Sickness; 9 are open to participants now.

This study's enrollment of 55 is close to the median of 59 across 44 interventional studies indexed under Motion Sickness.

Browse Motion Sickness studies →

Lead sponsor

Affiliated Hospital of Jiaxing University is the lead sponsor of 17 studies on the registry; 10 are open to participants now.

Counted across the registry records on this site, refreshed daily.

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Who can participate

Ages eligible
41 Years to 65 Years
Sexes eligible
All
Accepts healthy volunteers
No

Go through the criteria one by one — yes, no or not sure — and take the list to your doctor or the study team. Kept in this browser only.

Inclusion criteria

Age 41-65 years ASA physical condition 1-3 18-30 kg/m2 undergoing arthroscopic shoulder surgery

Exclusion criteria

Exclusion Criteria:

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) for general anesthesia and/or interscalene nerve block and planned open shoulder arthrotomies Muscle related diseases

Terms in these criteria, in plain language(2)

Underlined terms in the criteria open these too. Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.

BMI (body mass index)

Weight in kilograms divided by height in metres squared. Example: 70 kg and 1.75 m gives 70 ÷ (1.75 × 1.75) ≈ 22.9.

What counts as overweight or obesity differs between countries (some use lower cut-offs), so go by the range the study states.

Contraindication

A reason a treatment, test or procedure should not be given to a particular person, such as an allergy, another illness or a medicine they take.

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Study design

Phase
Phase 4
Primary purpose
Diagnostic
Allocation
Randomized
Intervention model
Sequential assignment
Masking
Double (Participant, Investigator)
Enrollment
55 participants (actual)

Study arms

  • Experimental
    First patient's dose of bupivacaine liposome

    First patient's use of bupivacaine liposome and next patient's use of bupivacaine liposome

    Drug: First patient Bupivacaine liposome and next patient Bupivacaine liposome

  • Experimental
    next patient's dose of bupivacaine liposome

    First patient's use of bupivacaine liposome and next patient's use of bupivacaine liposome

    Drug: First patient Bupivacaine liposome and next patient Bupivacaine liposome

Interventions

  • DrugFirst patient Bupivacaine liposome and next patient Bupivacaine liposome

    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).

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What researchers measure

Primary outcomes

  1. 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

    Time frame: 72 hours after brachial plexus block

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Study locations

1 site
  • Affiliated Hospital of Jiaxing University
    Jiaxing, China
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References and documents

Individual participant data

Plan to share: No

No publications or documents are linked to this record.

09

Updates

Tracking since Sep 25, 2026
No changes since tracking began. The registry record was last updated on Dec 29, 2025, before this site started recording changes on Sep 25, 2026. Its history is on ClinicalTrials.gov ↗
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Registry details

Key details

Study ID
NCT06587386
Lead sponsor
Affiliated Hospital of Jiaxing University
Responsible party
Qing-he Zhou (Dr., Affiliated Hospital of Jiaxing University) — Principal investigator
First posted
Sep 19, 2024
Start date
May 20, 2025
Primary completion
Nov 10, 2025
Completion
Nov 10, 2025
Last update
Dec 29, 2025

Study contacts

Qinghe Zhou
study chair · Affiliated Hospital of Jiaxing University

Oversight

Data monitoring committee
Yes
FDA-regulated drug
No
FDA-regulated device
No
View the source record on ClinicalTrials.gov ↗

Not currently enrolling

This study is completed, as verified in Dec 2025. You cannot join it, but the record below documents what was studied.

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