Finding the best dose of liposomal bupivacaine for knee surgery pain relief
Determination of the Optimal Volume of Liposomal Bupivacaine in Single-Shot Adductor Canal Block for Knee Joint Surgery-A Phase I/II Trial
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 |
| Enrollment | 63 (estimated) |
| Ages | 18 Years to 85 Years |
| Sex | All |
| Sponsor | Nanjing First Hospital, Nanjing Medical University Academic / other |
| Locations | 1 site (Nanjing, Jiangsu) |
| Trial ID | NCT06942689 on ClinicalTrials.gov |
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.
Who should consider this trial
Good fit: Ideal candidates are adults aged 18 to 65 undergoing elective knee joint surgery with a BMI of 35 or less.
Not a fit: Patients with conditions such as femoral neuropathy, coagulation dysfunction, or a history of chronic pain may not benefit from this study.
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 performed: Other studies have successfully utilized similar Bayesian design methodologies for volume optimization in regional anesthesia, indicating potential for success in this approach.
Eligibility criteria
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 this trial is running
Nanjing, Jiangsu
- 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 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.