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NCT Number: NCT07509866

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

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.

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Key information

Conditions

Total Knee Anthroplasty Liposomal Bupivacaine Nerve Block Ropivacaine

Age range

18 year–80 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

Union Hospital, Tongji Medical College, Huazhong University of Science and Technology

Wuhan, Hubei, 430022, China

Location status: Recruiting

Location contact

You-nian Xu, Professor

CONTACT

[email protected]

+8613657263415

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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)

Treatment and study plan

Liposomal bupivacaine (LB)

Drug

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

Drug

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

Drug

Ropivacaine 0.375% with dexmedetomidine 1 μg/kg (actual body weight). Total 40 mL (20 mL per block) via ultrasound-guided ACB and IPACK

Primary outcomes

  1. Total opioid consumption

    Time frame: 72 hours

    Total postoperative opioid consumption within 72 hour after surgery.

Secondary outcomes

  1. Pain scores at rest and during movement

    Time frame: 72 hours

    Visual Analog Scale (VAS, 0-100 mm) within 72 hour postoperatively.

  2. Time to First Ambulation

    Time frame: Postoperative day 0-2

    Time from arrival in PACU to first ambulation

  3. Duration of Hospital Stay

    Time frame: 0-30 days

    Time from surgery to hospital discharge, measured in days.

  4. Patient Satisfaction with Pain Management

    Time frame: 24 hours, 48 hours and 27 hours postoperatively

    Patient satisfaction assessed using a 5-point Likert scale (1 = very dissatisfied, 5 = very satisfied).

  5. Quality of Recovery

    Time frame: 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.

Study contacts

Contact information is provided by the study sponsor or research team.

Xi Wu

CONTACT

[email protected]

+8615871715431

Sponsors and collaborators

Lead sponsor

Huazhong University of Science and Technology

Other

Registry information

Official study title

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

Important dates

Study start
2026
Primary completion
2026
Study completion
2026
First posted
Apr 3, 2026
Registry last updated
Apr 14, 2026

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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