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Clinical Trials in China / NCT07509866
Recruiting Not applicable

Liposomal Bupivacaine Versus Ropivacaine With Perineural Dexamethasone or Dexmedetomidine as Adjuncts for Adductor Canal Block Combined With IPACK Block in Total Knee Arthroplasty

NCT07509866 · tracked via the Priya Life Science China tracker
Sponsor
Huazhong University of Science and Technology
Phase
Not applicable
Started
2026-04-09
Last updated
2026-09-10

Condition(s) studied

Total Knee AnthroplastyNerve BlockRopivacaineLiposomal Bupivacaine

Investigational drug(s) / intervention(s)

Liposomal bupivacaine (LB)Ropivacaine with Perineural DexamethasoneRopivacaine with Perineural Dexmedetomidine

Liposomal bupivacaine (LB): 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.

Ropivacaine 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

Ropivacaine 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

Study 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.

Eligibility

Sex
ALL
Min age
18 Years
Max age
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)

Primary outcome measure(s)

Trial sites (1)

FacilityCityRegionStatus
Union Hospital, Tongji Medical College, Huazhong University of Science and Technology Wuhan Hubei Recruiting

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Official registry record

This page summarises publicly available registry data for informational purposes — not medical advice. Eligibility is determined by each study team; patients should discuss participation with their clinician.

View NCT07509866 on ClinicalTrials.gov ↗ ← All trials in China