Total Knee Anthroplasty, Nerve Block, Ropivacaine, Liposomal Bupivacaine
Conditions
Keywords
total knee arthroplasty, adductor canal block, IPACK block, liposomal bupivacaine, ropivacaine, perineural adjuncts, dexamethasone, dexmedetomidine, multimodal analgesia
Brief summary
Effective postoperative pain management remains a cornerstone of enhanced recovery protocols following total knee arthroplasty (TKA). Inadequate analgesia not only compromises patient satisfaction but also impedes early mobilization and rehabilitation, thereby increasing the risk of perioperative complications. Current multimodal analgesic strategies frequently incorporate regional techniques, with the adductor canal block (ACB) and infiltration between the popliteal artery and capsule of the knee (IPACK) block emerging as established modalities that provide motor-sparing analgesia. Despite their widespread adoption, the optimal local anesthetic regimen for these blocks remains undefined. While liposomal bupivacaine has garnered interest for its extended duration of action, its clinical efficacy relative to conventional local anesthetics combined with perineural adjuncts remains a subject of ongoing debate. Specifically, perineural dexamethasone and dexmedetomidine have each demonstrated the capacity to prolong the analgesic duration of ropivacaine; however, direct comparative data among these three distinct strategies-liposomal bupivacaine alone versus ropivacaine supplemented with either adjunct-are notably limited. Given the absence of head-to-head randomized trials evaluating these three clinically viable techniques, the optimal approach to maximize analgesic duration while minimizing opioid-related adverse effects remains unclear. This study therefore aims to compare the analgesic efficacy and safety profiles of liposomal bupivacaine, ropivacaine with perineural dexamethasone, and ropivacaine with perineural dexmedetomidine when administered via ACB and IPACK blocks in patients undergoing TKA.
Interventions
Liposomal bupivacaine 6.65% injection. A total volume of 40 mL will be administered as ultrasound-guided adductor canal block (ACB) and infiltration between the popliteal artery and capsule of the knee (IPACK) block, divided as 20 mL for each block, prior to surgical incision.
DRUGRopivacaine with Perineural Dexamethasone
Ropivacaine 0.375% combined with dexamethasone 4 mg per block (total 8 mg) as a perineural adjunct. A total volume of 40 mL will be administered as ultrasound-guided adductor canal block (ACB) and infiltration between the popliteal artery and capsule of the knee (IPACK) block, divided as 20 mL for each block
DRUGRopivacaine with Perineural Dexmedetomidine
Ropivacaine 0.375% with dexmedetomidine 1 μg/kg (actual body weight). Total 40 mL (20 mL per block) via ultrasound-guided ACB and IPACK
Sponsors
Huazhong University of Science and Technology
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT
Masking
QUADRUPLE (Subject, Caregiver, Investigator, Outcomes Assessor)
Eligibility
Sex/Gender
ALL
Age
18 Years to 80 Years
Healthy volunteers
No
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)
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Total opioid consumption | 72 hours | Total postoperative opioid consumption within 72 hour after surgery. |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| Pain scores at rest and during movement | 72 hours | Visual Analog Scale (VAS, 0-100 mm) within 72 hour postoperatively. |
| Time to First Ambulation | Postoperative day 0-2 | Time from arrival in PACU to first ambulation |
| Duration of Hospital Stay | 0-30 days | Time from surgery to hospital discharge, measured in days. |
| Patient Satisfaction with Pain Management | 24 hours, 48 hours and 27 hours postoperatively | Patient satisfaction assessed using a 5-point Likert scale (1 = very dissatisfied, 5 = very satisfied). |
| Quality of Recovery | Postoperative day 1-3 | Quality of recovery assessed using the Quality of Recovery-15 (QoR-15) questionnaire. Scores range from 0 to 150, with higher scores indicating better recovery. |
Countries
China
Contacts
CONTACTXi Wu
Outcome results
None listed