Finding the best dose of liposomal bupivacaine for knee surgery pain relief
Official title: Determination of the Optimal Volume of Liposomal Bupivacaine in Single-Shot Adductor Canal Block for Knee Joint Surgery-A Phase I/II Trial
Run by Nanjing First Hospital, Nanjing Medical University · NCT06942689 · Data updated 2026-11-12
This study is testing the best amount of a pain relief medication for people having knee surgery to see how it can help them feel better after the operation.
Quick facts
| Phase | Phase 4 |
|---|---|
| Study type | Interventional |
| Ages | 18 Years to 85 Years |
| Sex | All |
| Enrollment | 80 (estimated) |
| Sponsor | Nanjing First Hospital, Nanjing Medical University Academic / other |
| Locations | 1 site (Nanjing, Jiangsu) |
| Status | Recruiting |
| Started | June 1, 2025 |
| Main results expected | December 31, 2027 |
| Study ends | December 31, 2027 |
| Registry record updated | September 10, 2026 |
| Trial ID | NCT06942689 on ClinicalTrials.gov |
Is this trial a fit for you?
✓Likely a good fit
Ideal candidates are adults aged 18 to 65 undergoing elective knee joint surgery with a BMI of 35 or less.
✕Probably not a fit
Patients with conditions such as femoral neuropathy, coagulation dysfunction, or a history of chronic pain may not benefit from this study.
A plain-English reading of the study's rules. Only the study team can confirm whether you qualify.
What this trial studies
This study aims to determine the optimal volume of liposomal bupivacaine used in adductor canal blocks for patients undergoing knee joint surgery. Utilizing advanced Bayesian design methodologies, the research will systematically evaluate how different volumes affect pain relief and quadriceps muscle strength. The goal is to provide precise dosing recommendations that enhance personalized analgesic protocols for knee surgery. By employing a seamless dose-finding strategy, this study seeks to improve postoperative pain management.
Why it matters
Potential benefit: If successful, this study could lead to more effective pain management protocols for knee surgery patients.
How similar studies have gone: Other studies have successfully utilized similar Bayesian design methodologies for volume optimization in regional anesthesia, indicating potential for success in this approach.
Who can join: the full rules
Show full inclusion / exclusion criteria
Inclusion Criteria: * Patients undergoing elective general anesthesia for unilateral knee joint surgery. * Patients who provide informed consent. * Aged between 18 and 65 years old, regardless of gender. * American Society of Anesthesiologists (ASA) physical status classification of Ⅰ to Ⅲ * Body mass index (BMI) ≤ 35 kg/m². Exclusion Criteria: * Femoral neuropathy. * Coagulation dysfunction. * Allergy to local anesthetics. * Infection at the puncture site. * History of chronic pain or opioid use. * Pregnancy. * Diabetes mellitus and peripheral neuropathy.
Where it's running
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Nanjing First Hospital
Nanjing, Jiangsu, China Recruiting
Study contacts
- Principal investigator: Hongwei Shi — The First Affiliated Hospital with Nanjing Medical University
- Study coordinator: Liu Han
- Email: han_cold.student@sina.com
- Phone: 18951670163
How to take part
- Review the eligibility criteria above with your treating physician.
- Check the official listing on ClinicalTrials.gov for the latest contact details and recruitment status.
- Contact the study coordinator or principal investigator to ask for pre-screening. Pre-screening is free and never obligates you to enroll.