Different doses of liposomal bupivacaine for adductor canal block after total knee replacement
Analgesic Efficacy of Different Liposomal Bupivacaine Doses in the Adductor Canal Block for Total Knee Arthroplasty: a Randomized Controlled Trial
This will test whether different doses of liposomal bupivacaine given in the adductor canal block reduce pain and opioid use after elective total knee replacement in adults.
Quick facts
| Phase | Phase 3 |
|---|---|
| Study type | Interventional |
| Enrollment | 177 (estimated) |
| Ages | 18 Years to 80 Years |
| Sex | All |
| Sponsor | The University of Hong Kong Academic / other |
| Locations | 1 site (Hong Kong, Hong Kong) |
| Trial ID | NCT06740214 on ClinicalTrials.gov |
What this trial studies
Adults undergoing elective primary unilateral robotic total knee arthroplasty at a single center will receive one of three adductor canal block formulations: standard 0.5% bupivacaine, 1.33% liposomal bupivacaine combined with 0.5% standard bupivacaine, or 1.33% liposomal bupivacaine alone. Pain scores, opioid consumption, and other postoperative outcomes will be recorded in the acute recovery period to compare analgesic duration and effectiveness across doses. The protocol targets ASA I–III patients aged 18–80 and excludes revision, bilateral, or complex procedures and patients with chronic opioid use or certain medical comorbidities. The intervention uses the recently FDA-approved liposomal bupivacaine formulation applied via the adductor canal block to explore optimal dosing for postoperative analgesia.
Who should consider this trial
Good fit: Ideal candidates are adults aged 18–80 with ASA I–III scheduled for elective primary unilateral robotic total knee arthroplasty who can consent and speak Cantonese, Mandarin, or English.
Not a fit: Patients with revision or bilateral or complex TKA, chronic opioid use, certain allergies, significant immunosuppression, or specific cardiac conditions are unlikely to benefit or be eligible for this protocol.
Why it matters
Potential benefit: If successful, the right dose could provide longer-lasting pain relief, lower opioid requirements, and smoother early rehabilitation after knee replacement.
How similar studies have performed: Liposomal bupivacaine has FDA approval for this use and some studies show benefit, but published results have been mixed and the optimal dosing strategy remains unclear.
Eligibility criteria
Show full inclusion / exclusion criteria
Inclusion Criteria: * ASA I-III * Age 18-80 years old * Scheduled for elective primary unilateral total knee arthroplasty (TKA) with robotic surgery * Able to speak and understand Cantonese or Mandarin or English * Able to provide informed oral and written consent Exclusion Criteria: * Revision TKA * Single-stage bilateral TKA * Complex primary TKA requiring use of stem/augment/constrained liner * Surgeries with significant intraoperative complications which may alter rehabilitation protocol eg collateral ligament injury, fracture requiring fixation * Known allergy to opioids, local anaesthetic drugs, paracetamol, non-steroidal anti-inflammatory drugs (NSAIDS) including COX-2 inhibitors * History of chronic pain other than chronic knee pain * History of immunosuppression * Chronic use of glucocorticoids * Chronic opioid use (morphine, fentanyl, hydromorphone, ketobemidone, methadone, nicomorphine, oxycodone, or meperidine) * History of congestive heart failure (NYHA 2) * Alcohol or drug abuse * Impaired renal function (defined as effective glomerular filtration rate \< 30ml/min/1.73m2 * Impaired liver function (defined as plasma bilirubin over 34mol/L; international normalized ratio \[INR\] \>= 1.7, alanine aminotransferase \[ALT\] over 100U/L, aspartate aminotransferase \[AST\] over 100U/L) * Coagulopathy (platelet count \<100,000/ml and/or INR \>= 1.5) or the use of anticoagulants (not including aspirin) that precludes the use of adductor canal blocks * Pre-existing neurological or muscular disorders * Psychiatric illness * Impaired mental state * Pregnancy * Local infection * On immunosuppressants * High body mass index (BMI) (\>=40) * Patient refusal for regional nerve blocks or to conduct clinical trial
Where this trial is running
Hong Kong, Hong Kong
- The University of Hong Kong — Hong Kong, Hong Kong, Hong Kong (Recruiting)
Study contacts
- Study coordinator: Stanley S.C. WONG, MD (HKU)
- Email: wongstan@hku.hk
- Phone: (852) 2255 3303
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.