Exploring the effective dose of liposomal bupivacaine for shoulder surgery
The Minimum Effective Dose (ED90) of Liposomal Bupivacaine for Preserving Motor Function After Interscalene Brachial Plexus Block: a Dose-finding Study
This study is testing how much liposomal bupivacaine is needed to help manage pain after shoulder surgery without affecting movement, compared to regular bupivacaine.
Quick facts
| Phase | Phase 4 |
|---|---|
| Study type | Interventional |
| Enrollment | 54 (estimated) |
| Ages | 41 Years to 65 Years |
| Sex | All |
| Sponsor | Affiliated Hospital of Jiaxing University Academic / other |
| Locations | 1 site (Jiaxing) |
| Trial ID | NCT06587386 on ClinicalTrials.gov |
What this trial studies
This study investigates the minimum effective dose of liposomal bupivacaine aimed at preserving motor function following intermuscular groove brachial plexus block during shoulder arthroscopy. Utilizing a biased coin design sequential method, the research will determine the 90% effective dose of this anesthetic. The goal is to enhance postoperative outcomes by minimizing motor function impairment while managing pain. Participants will receive either liposomal bupivacaine or standard bupivacaine in a sequential manner.
Who should consider this trial
Good fit: Ideal candidates are adults aged 41-65 years with ASA physical condition 1-3 and a BMI of 18-30 kg/m2 who are scheduled for arthroscopic shoulder surgery.
Not a fit: Patients with preexisting neuropathy, chronic pain syndromes, or severe respiratory conditions may not benefit from this study.
Why it matters
Potential benefit: If successful, this study could lead to improved pain management techniques that preserve motor function for patients undergoing shoulder surgery.
How similar studies have performed: While similar studies have explored the use of liposomal bupivacaine, this specific approach to determining the minimum effective dose is novel.
Eligibility criteria
Show full inclusion / exclusion criteria
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
Where this trial is running
Jiaxing
- Affiliated Hospital of Jiaxing University — Jiaxing, China (Recruiting)
Study contacts
- Study coordinator: Qinghe Zhou
- Email: zqh10980@zjxu.edu.edu.cn
- Phone: 13732573379
How to participate
- Review the eligibility criteria above with your treating physician.
- Visit the official trial page on ClinicalTrials.gov for the most current contact information and recruitment status.
- Contact the listed study coordinator or principal investigator to request pre-screening. Pre-screening is free and never obligates you to enroll.