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

Affiliated Hospital of Jiaxing University55 enrolled

Overview

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

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

Allocation

RANDOMIZED

Purpose

DIAGNOSTIC

Masking

DOUBLE

Enrollment

Conditions

Motion Sickness

Interventions

First patient Bupivacaine liposome and next patient Bupivacaine liposomeDRUG

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).

Eligibility

Sex: ALLMin age: 41 YearsMax age: 65 Years

Medical Language ↔ Plain English

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

Locations (1)

Affiliated Hospital of Jiaxing University

Jiaxing, China

Outcomes

Primary Outcomes

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

Time frame: 72 hours after brachial plexus block

Data from ClinicalTrials.gov

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