Liposomal bupivacaine versus ropivacaine with dexamethasone or dexmedetomidine for adductor canal plus IPACK block in total knee replacement
A Randomized Trial of Liposomal Bupivacaine, Ropivacaine With Perineural Dexamethasone, and Ropivacaine With Perineural Dexmedetomidine for Adductor Canal Block Combined With IPACK Block in Total Knee Arthroplasty
This trial will test whether liposomal bupivacaine or ropivacaine with added dexamethasone or dexmedetomidine provides longer-lasting, better pain control after total knee replacement.
Quick facts
| Phase | Not applicable |
|---|---|
| Study type | Interventional |
| Enrollment | 90 (estimated) |
| Ages | 18 Years to 80 Years |
| Sex | All |
| Sponsor | Huazhong University of Science and Technology Academic / other |
| Locations | 1 site (Wuhan, Hubei) |
| Trial ID | NCT07509866 on ClinicalTrials.gov |
What this trial studies
Adults undergoing elective primary unilateral total knee arthroplasty receive combined adductor canal and IPACK blocks and are assigned to one of three regimens: liposomal bupivacaine, roopivacaine plus perineural dexamethasone, or ropivacaine plus perineural dexmedetomidine. The protocol compares postoperative pain scores, opioid consumption, early mobilization, and adverse events to identify the most effective motor-sparing analgesic approach. Eligible participants are aged 18–80 with ASA physical status I–III and BMI 18–35 kg/m², with standard exclusions for infection at the injection site, coagulopathy, relevant drug allergies, and significant organ dysfunction. By directly comparing an extended-release local anesthetic to conventional ropivacaine with adjuncts, the trial aims to clarify a practical regimen for enhanced recovery after TKA.
Who should consider this trial
Good fit: Ideal candidates are adults aged 18–80 scheduled for elective primary unilateral total knee arthroplasty who meet ASA I–III and BMI 18–35 criteria and can provide informed consent.
Not a fit: Patients with known allergies to the study drugs, active injection-site infection, coagulopathy or anticoagulation, severe cardiac/hepatic/renal disease, or uncontrolled hypertension or diabetes are excluded and unlikely to benefit from participation.
Why it matters
Potential benefit: If successful, the preferred regimen could reduce postoperative pain and opioid use and help patients begin rehabilitation sooner after knee replacement.
How similar studies have performed: Previous studies have shown that perineural dexamethasone or dexmedetomidine and liposomal bupivacaine can prolong regional block duration, but direct head-to-head comparisons in total knee arthroplasty are limited and results have been mixed.
Eligibility criteria
Show full inclusion / exclusion criteria
Inclusion Criteria: * Patients scheduled for elective primary unilateral total knee arthroplasty * Age ≥ 18 years and ≤ 80 years * American Society of Anesthesiologists (ASA) physical status I-III * Body mass index (BMI) ≥ 18 kg/m² and ≤ 35 kg/m² * Ability to understand and provide written informed consent Exclusion Criteria: * Known allergy or contraindication to local anesthetics (bupivacaine, ropivacaine), dexamethasone, dexmedetomidine, or opioids * Infection at the injection site * Coagulopathy or current use of anticoagulants * Severe cardiovascular disease (New York Heart Association \[NYHA\] functional class III or IV, or recent myocardial infarction within 6 months) * Severe hepatic impairment (Child-Pugh class C) or renal impairment (estimated glomerular filtration rate \[eGFR\] \< 30 mL/min/1.73 m²) * Uncontrolled hypertension (systolic blood pressure \> 180 mmHg or diastolic blood pressure \> 110 mmHg despite medical therapy) * Uncontrolled diabetes mellitus (HbA1c \> 8.5%) * Bilateral TKA or revision TKA * Chronic opioid use (daily opioid consumption for \> 3 months prior to surgery) * Participation in another interventional clinical trial within 30 days prior to enrollment * Inability to communicate with study personnel or complete pain assessments (e.g., language barrier, cognitive impairment)
Where this trial is running
Wuhan, Hubei
- Union Hospital, Tongji Medical College, Huazhong University of Science and Technology — Wuhan, Hubei, China (Recruiting)
Study contacts
- Study coordinator: Xi Wu
- Email: wu2018whuh@163.com
- Phone: +8615871715431
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.