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ED90 of Liposomal Bupivacaine for Preserving Motor Function in Shoulder Arthroscopy
NCT06587386Phase 4
Key facts
- Status
- Completed
- Start
- May 2025
- Primary completion
- Nov 2025
- Countries
- 1
- Sponsor
- The Affiliated Hospital of Jiaxing University
- Modality
- Small Molecules
- Conditions
- postoperative pain
01
Overview
Phase 4, open-label trial of liposomal bupivacaine in postoperative pain (2 arms), sponsored by The Affiliated Hospital of Jiaxing University. Primary endpoint: 90% minimum effective dose for preserving motor function at 72 hours. Started May 2025; status: completed.
02
Design
2 arms- Study design
- Non-randomizedOpen-label
First patient's dose of bupivacaine liposome
First patient receives 66.5mg (15ml)
next patient's dose of bupivacaine liposome
Dose adjusted based on previous patient's response
03
Who it enrols
Adults aged 41-65 with BMI 18-30 undergoing arthroscopic shoulder surgery, excluding those with chronic pain, neuropathy, severe respiratory conditions, or chronic opioid use.
04
Endpoints
Primary
90% minimum effective dose for preserving motor function
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