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

NCT06587386 · Status: COMPLETED · Phase: PHASE4 · Type: INTERVENTIONAL · Enrollment: 55

Last updated 2025-12-29

No results posted yet for this study

Summary

Explore the minimum effective dose of liposomal bupivacaine for preserving motor function

Conditions

Interventions

DRUG

First 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).

Sponsors & Collaborators

  • Affiliated Hospital of Jiaxing University

    lead OTHER

Principal Investigators

  • Qinghe Zhou · Affiliated Hospital of Jiaxing University

Study Design

Allocation
RANDOMIZED
Purpose
DIAGNOSTIC
Masking
DOUBLE
Model
SEQUENTIAL

Eligibility

Min Age
41 Years
Max Age
65 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2025-05-20
Primary Completion
2025-11-10
Completion
2025-11-10

Countries

  • China

Study Locations

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Entities

Diseases

Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT06587386 on ClinicalTrials.gov