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

NCT ID: NCT06587386

Last Updated: 2025-12-29

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

COMPLETED

Clinical Phase

PHASE4

Total Enrollment

55 participants

Study Classification

INTERVENTIONAL

Study Start Date

2025-05-20

Study Completion Date

2025-11-10

Brief Summary

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

Detailed Description

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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

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Motion Sickness

Keywords

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Shoulder surgery Intermuscular sulcus brachial plexus block Bupivacaine liposome Effective dose

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

SEQUENTIAL

Primary Study Purpose

DIAGNOSTIC

Blinding Strategy

DOUBLE

Participants Investigators

Study Groups

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First patient's dose of bupivacaine liposome

First patient's use of bupivacaine liposome and next patient's use of bupivacaine liposome

Group Type EXPERIMENTAL

First patient Bupivacaine liposome and next patient Bupivacaine liposome

Intervention Type 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).

next patient's dose of bupivacaine liposome

First patient's use of bupivacaine liposome and next patient's use of bupivacaine liposome

Group Type EXPERIMENTAL

First patient Bupivacaine liposome and next patient Bupivacaine liposome

Intervention Type 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).

Interventions

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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).

Intervention Type DRUG

Eligibility Criteria

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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
Minimum Eligible Age

41 Years

Maximum Eligible Age

65 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No

Sponsors

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Affiliated Hospital of Jiaxing University

OTHER

Sponsor Role lead

Responsible Party

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Qing-he Zhou

Dr.

Responsibility Role PRINCIPAL_INVESTIGATOR

Principal Investigators

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Qinghe Zhou

Role: STUDY_CHAIR

Affiliated Hospital of Jiaxing University

Locations

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Affiliated Hospital of Jiaxing University

Jiaxing, , China

Site Status

Countries

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China

Other Identifiers

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2024-KY-656-002

Identifier Type: -

Identifier Source: org_study_id