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

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

Study Overview

• Status: Completed
• Conditions: Motion Sickness
• Intervention / Treatment: Drug: First patient Bupivacaine liposome and next patient Bupivacaine liposome

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 Type: Interventional
• Enrollment (Actual): 55
• Phase: Phase 4

Contacts and Locations

Study Locations

• China
  • Jiaxing, China
    • Affiliated Hospital of Jiaxing University

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: Adult; Older Adult
• Accepts Healthy Volunteers: No

Description

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 Plan

How is the study designed?

Design Details

• Primary Purpose: Diagnostic
• Allocation: Randomized
• Interventional Model: Sequential Assignment
• Masking: Double

Number of Arms

2

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
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; 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).
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; 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).

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
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	72 hours after brachial plexus block

Collaborators and Investigators

• Sponsor: Affiliated Hospital of Jiaxing University
• Investigators: Study Chair: Qinghe Zhou, Affiliated Hospital of Jiaxing University

Study record dates

Study Major Dates

• Study Start (Actual): May 20, 2025
• Primary Completion (Actual): November 10, 2025
• Study Completion (Actual): November 10, 2025

Study Registration Dates

• First Submitted: September 3, 2024
• First Submitted That Met QC Criteria: September 5, 2024
• First Posted (Actual): September 19, 2024

Study Record Updates

• Last Update Posted (Actual): December 29, 2025
• Last Update Submitted That Met QC Criteria: December 20, 2025
• Last Verified: December 1, 2025

More Information

Terms related to this study

• Keywords: Shoulder surgery; Bupivacaine liposome; Intermuscular sulcus brachial plexus block; Effective dose
• Additional Relevant MeSH Terms: Pathological Conditions, Signs and Symptoms; Signs and Symptoms; Motion Sickness; Physiological Effects of Drugs; Peripheral Nervous System Agents; Anesthetics, Local; Anesthetics; Central Nervous System Depressants; Sensory System Agents; Bupivacaine
• Other Study ID Numbers: 2024-KY-656-002

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: NO

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No
• product manufactured in and exported from the U.S.: No