- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT07509866
Liposomal Bupivacaine Versus Ropivacaine With Perineural Dexamethasone or Dexmedetomidine as Adjuncts for Adductor Canal Block Combined With IPACK Block in Total Knee Arthroplasty
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
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.
Study Overview
Status
Study Type
Enrollment (Estimated)
Phase
- Not Applicable
Contacts and Locations
Study Contact
- Name: Xi Wu
- Phone Number: +8615871715431
- Email: wu2018whuh@163.com
Study Locations
-
-
Hubei
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Wuhan, Hubei, China, 430022
- Recruiting
- Union Hospital, Tongji Medical College, Huazhong University of Science and Technology
-
Contact:
- You-nian Xu, Professor
- Phone Number: +8613657263415
- Email: xyn0103@hust.edu.cn
-
-
Participation Criteria
Eligibility Criteria
Ages Eligible for Study
- Adult
- Older Adult
Accepts Healthy Volunteers
Description
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)
Study Plan
How is the study designed?
Design Details
- Primary Purpose: Treatment
- Allocation: Randomized
- Interventional Model: Parallel Assignment
- Masking: Quadruple
Arms and Interventions
Participant Group / Arm |
Intervention / Treatment |
|---|---|
|
Experimental: Liposomal Bupivacaine Group
Participants assigned to this arm will receive ultrasound-guided adductor canal block (ACB) and infiltration between the popliteal artery and capsule of the knee (IPACK) block using liposomal bupivacaine 6.65%.
A total volume of 40 mL will be administered, divided as 20 mL for the ACB and 20 mL for the IPACK block
|
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.
|
|
Active Comparator: Ropivacaine with perineural adjuncts Group
Participants assigned to this arm will receive ultrasound-guided adductor canal block (ACB) and infiltration between the popliteal artery and capsule of the knee (IPACK) block using ropivacaine 0.375% supplemented with perineural dexmedetomidine 1 μg/kg or perineural dexamethasone 4 mg.
A total volume of 40 mL will be administered, divided as 20 mL for the ACB and 20 mL for the IPACK block.
|
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 0.375% with dexmedetomidine 1 μg/kg (actual body weight).
Total 40 mL (20 mL per block) via ultrasound-guided ACB and IPACK
|
What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
|---|---|---|
|
Total opioid consumption
Time Frame: 72 hours
|
Total postoperative opioid consumption within 72 hour after surgery.
|
72 hours
|
Secondary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
|---|---|---|
|
Pain scores at rest and during movement
Time Frame: 72 hours
|
Visual Analog Scale (VAS, 0-100 mm) within 72 hour postoperatively.
|
72 hours
|
|
Time to First Ambulation
Time Frame: Postoperative day 0-2
|
Time from arrival in PACU to first ambulation
|
Postoperative day 0-2
|
|
Duration of Hospital Stay
Time Frame: 0-30 days
|
Time from surgery to hospital discharge, measured in days.
|
0-30 days
|
|
Patient Satisfaction with Pain Management
Time Frame: 24 hours, 48 hours and 27 hours postoperatively
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Patient satisfaction assessed using a 5-point Likert scale (1 = very dissatisfied, 5 = very satisfied).
|
24 hours, 48 hours and 27 hours postoperatively
|
|
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.
|
Postoperative day 1-3
|
Collaborators and Investigators
Publications and helpful links
General Publications
- Desai N, Kirkham KR, Albrecht E. Local anaesthetic adjuncts for peripheral regional anaesthesia: a narrative review. Anaesthesia. 2021 Jan;76 Suppl 1:100-109. doi: 10.1111/anae.15245.
- Yuan Q,Shen W,He W,Wang X,Liu F,Zhang Y,Lu X,Guan Z,Zhang J,Yang L
- Yang Z, Li S, Shen M, Lei W, Huang Y, Sun J, Cheng Y, Lu X. Efficacy and safety of liposomal bupivacaine versus ropivacaine with two adjuncts in serratus anterior plane block for video-assisted thoracoscopic surgery: a protocol for a single-centre, randomised, double-blinded trial. BMJ Open. 2025 Sep 17;15(9):e102326. doi: 10.1136/bmjopen-2025-102326.
- Hussain N, Brummett CM, Brull R, Alghothani Y, Moran K, Sawyer T, Abdallah FW. Efficacy of perineural versus intravenous dexmedetomidine as a peripheral nerve block adjunct: a systematic review. Reg Anesth Pain Med. 2021 Aug;46(8):704-712. doi: 10.1136/rapm-2020-102353. Epub 2021 May 11.
- Liao C, Li J, Hu X, Sun Y, Zheng K, Pan X, Wang L. Liposomal Bupivacaine Versus Ropivacaine With Perineural Dexamethasone in Adductor Canal Block for Total Knee Arthroplasty: A Randomized Clinical Trial. J Arthroplasty. 2025 Nov 13:S0883-5403(25)01440-8. doi: 10.1016/j.arth.2025.11.015. Online ahead of print.
- Kim DH, Liu J, Beathe JC, Lin Y, Wetmore DS, Kim SJ, Haskins SC, Garvin S, Oxendine JA, Ho MC, Allen AA, Popovic M, Gbaje E, Wu CL, Memtsoudis SG. Interscalene Brachial Plexus Block with Liposomal Bupivacaine versus Standard Bupivacaine with Perineural Dexamethasone: A Noninferiority Trial. Anesthesiology. 2022 Mar 1;136(3):434-447. doi: 10.1097/ALN.0000000000004111.
Helpful Links
Study record dates
Study Major Dates
Study Start (Actual)
Primary Completion (Estimated)
Study Completion (Estimated)
Study Registration Dates
First Submitted
First Submitted That Met QC Criteria
First Posted (Actual)
Study Record Updates
Last Update Posted (Actual)
Last Update Submitted That Met QC Criteria
Last Verified
More Information
Terms related to this study
Keywords
Additional Relevant MeSH Terms
Other Study ID Numbers
- WHUH20260327
Plan for Individual participant data (IPD)
Plan to Share Individual Participant Data (IPD)?
IPD Plan Description
Drug and device information, study documents
Studies a U.S. FDA-regulated drug product
Studies a U.S. FDA-regulated device product
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