Motion Sickness
Conditions
Keywords
Shoulder surgery, Intermuscular sulcus brachial plexus block, Bupivacaine liposome, Effective dose
Brief summary
Explore the minimum effective dose of liposomal bupivacaine for preserving motor function
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.
Interventions
DRUGFirst 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).
Sponsors
Affiliated Hospital of Jiaxing University
Study design
Allocation
RANDOMIZED
Intervention model
SEQUENTIAL
Primary purpose
DIAGNOSTIC
Masking
DOUBLE (Subject, Investigator)
Eligibility
Sex/Gender
ALL
Age
41 Years to 65 Years
Healthy volunteers
No
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
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| ED90 of motor function was preserved 72 hours after brachial plexus block | 72 hours after brachial plexus block | Evaluate the effective sensory blockade for maintaining motor function at the time point |
Countries
China
Outcome results
None listed