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

Affiliated Hospital of Jiaxing University

Status and phase: Completed; Phase 4

Conditions: Motion Sickness

Treatments: Drug: First patient Bupivacaine liposome and next patient Bupivacaine liposome

Study type: Interventional

Funder types: Other

Identifiers

NCT06587386

2024-KY-656-002

Details and patient eligibility

About

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

Full 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.

Enrollment: 55 patients

Sex: All

Ages: 41 to 65 years old

Volunteers: No Healthy Volunteers

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

Trial design

Primary purpose: Diagnostic

Allocation: Randomized

Interventional model: Sequential Assignment

Masking: Double Blind

---

55 participants in 2 patient groups

First patient's dose of bupivacaine liposome

Experimental group

Description:

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

Treatment:

Drug: First patient Bupivacaine liposome and next patient Bupivacaine liposome

next patient's dose of bupivacaine liposome

Experimental group

Description:

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

Treatment:

Drug: First patient Bupivacaine liposome and next patient Bupivacaine liposome