NCT06587386

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

The Minimum Effective Dose (ED90) of Liposomal Bupivacaine for Preserving Motor Function After Interscalene Brachial Plexus Block: a Dose-finding Study

• Status: Completed
• Phase: Phase 4
• Study type: Interventional
• Enrollment: 55 (actual)
• Sponsor: Affiliated Hospital of Jiaxing University · Academic / Other
• Sex: All
• Age: 41 Years – 65 Years
• Healthy volunteers: Not accepted

Summary

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.

Conditions

• Motion Sickness

Interventions

Type	Name	Description
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).

Timeline

• Start date: 2025-05-20
• Primary completion: 2025-11-10
• Completion: 2025-11-10
• First posted: 2024-09-19
• Last updated: 2025-12-29

Locations

1 site across 1 country: China