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

NCT06587386 | Completed Phase 4 DMC

• 1 other identifier: 2024-KY-656-002
• Study Type: interventional
• Target: 55
• Locations: 1 country
• Sites: 1

Brief Summary

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

Conditions

Motion Sickness

Keywords

Shoulder surgery; Intermuscular sulcus brachial plexus block; Bupivacaine liposome; Effective dose

Outcome Measures

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

  72 hours after brachial plexus block

Study Arms (2)

First patient's dose of bupivacaine liposome

EXPERIMENTAL

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

next patient's dose of bupivacaine liposome

EXPERIMENTAL

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

First patient Bupivacaine liposome and next patient Bupivacaine liposome DRUG

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).

First patient's dose of bupivacaine liposome; next patient's dose of bupivacaine liposome

Eligibility Criteria

• Age: 41 Years - 65 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

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

You may not qualify if:

• 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

Sponsors & Collaborators

• Affiliated Hospital of Jiaxing University: lead

Study Sites (1)

Affiliated Hospital of Jiaxing University

Jiaxing, China

Location

MeSH Terms

Conditions

Motion Sickness

Condition Hierarchy (Ancestors)

Signs and Symptoms; Pathological Conditions, Signs and Symptoms

Study Officials

• Qinghe Zhou

  Affiliated Hospital of Jiaxing University

  STUDY CHAIR

Study Design

• Study Type: interventional
• Phase: phase 4
• Allocation: RANDOMIZED
• Masking: DOUBLE
• Who Masked: PARTICIPANT, INVESTIGATOR
• Purpose: DIAGNOSTIC
• Intervention Model: SEQUENTIAL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Dr.

Study Record Dates

• First Submitted: September 3, 2024
• First Posted: September 19, 2024
• Study Start: May 20, 2025
• Primary Completion: November 10, 2025
• Study Completion: November 10, 2025
• Last Updated: December 29, 2025

Record last verified: 2025-12

Data Sharing

• IPD Sharing: Will not share

Locations

CN (1)