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

Trial statusRecruiting
Trial phaseNot applicable
Trial typeInterventional
Biological sexAll
Age18-80
SponsorHuazhong University of Science and Technology

About this trial

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 criteria

This trial does not accept healthy volunteers

Qualifiers

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

Disqualifiers

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)

Trial design

Design model

Parallel

Treatments tested in this trial

  • 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

Treatment groups

90 Participants
are divided into 2 treatment groups
Group A: Liposomal Bupivacaine GroupExperimental treatment 1 intervention
Group B: Ropivacaine with perineural adjuncts GroupActive comparator 2 interventions

Trial outcomes

Primary outcomes

1

Total opioid consumption

Total postoperative opioid consumption within 72 hour after surgery.

Time frame
72 hours

Secondary outcomes

1

Pain scores at rest and during movement

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

Time frame
72 hours
2

Time to First Ambulation

Time from arrival in PACU to first ambulation

Time frame
Postoperative day 0-2
3

Duration of Hospital Stay

Time from surgery to hospital discharge, measured in days.

Time frame
0-30 days
4

Patient Satisfaction with Pain Management

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

Time frame
24 hours, 48 hours and 27 hours postoperatively

Other outcomes

Sponsors and contacts

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