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

Phase 4

Recruiting

• Conditions: Motion Sickness
• Interventions: Drug: First patient Bupivacaine liposome and next patient Bupivacaine liposome

• Registration Number: NCT06587386
• Lead Sponsor: Affiliated Hospital of Jiaxing University

Brief 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.

Study Timeline

• Study First Submitted: 2024-09-03
• Study First Submitted QC: 2024-09-05
• Study First Posted: 2024-09-19
• Status Verified: 2025-05
• Last Update Submitted: 2025-05-14
• Last Update Posted: 2025-05-18
• Study Start: 2025-05-20
• Primary Completion: 2025-06-30
• Study Completion: 2025-06-30

Recruitment & Eligibility

• Status: RECRUITING
• Sex: All
• Target Recruitment: 54

Inclusion Criteria

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

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

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: SEQUENTIAL

Arm && Interventions

Group	Intervention	Description
the dose of bupivacaine liposome	First patient Bupivacaine liposome and next patient Bupivacaine liposome	First patient's use of bupivacaine liposome and next patient's use of bupivacaine liposome

Primary Outcome Measures

Name	Time	Method
MD90 of motor function was preserved 72 hours after brachial plexus block	72 hours after brachial plexus block	Evaluate the effective sensory blockade for maintaining motor function at the time point

Trial Locations

Locations (1)

Affiliated Hospital of Jiaxing University; 🇨🇳 Jiaxing, China