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
1 other identifier
interventional
90
1 country
1
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.
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at P50-P75 for not_applicable
Started Apr 2026
Shorter than P25 for not_applicable
1 active site
Health score is calculated from publicly available data and should be used for screening purposes only.
Trial Relationships
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Study Timeline
Key milestones and dates
First Submitted
Initial submission to the registry
March 28, 2026
CompletedFirst Posted
Study publicly available on registry
April 3, 2026
CompletedStudy Start
First participant enrolled
April 9, 2026
CompletedPrimary Completion
Last participant's last visit for primary outcome
October 30, 2026
ExpectedStudy Completion
Last participant's last visit for all outcomes
December 30, 2026
April 14, 2026
April 1, 2026
7 months
March 28, 2026
April 9, 2026
Conditions
Keywords
Outcome Measures
Primary Outcomes (1)
Total opioid consumption
Total postoperative opioid consumption within 72 hour after surgery.
72 hours
Secondary Outcomes (5)
Pain scores at rest and during movement
72 hours
Time to First Ambulation
Postoperative day 0-2
Duration of Hospital Stay
0-30 days
Patient Satisfaction with Pain Management
24 hours, 48 hours and 27 hours postoperatively
Quality of Recovery
Postoperative day 1-3
Study Arms (2)
Liposomal Bupivacaine Group
EXPERIMENTALParticipants 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
Ropivacaine with perineural adjuncts Group
ACTIVE COMPARATORParticipants 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.
Interventions
Ropivacaine 0.375% with dexmedetomidine 1 μg/kg (actual body weight). Total 40 mL (20 mL per block) via ultrasound-guided ACB and IPACK
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 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
Eligibility Criteria
You may qualify if:
- 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
You may not qualify if:
- 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)
Contact the study team to confirm eligibility.
Sponsors & Collaborators
Study Sites (1)
Union Hospital, Tongji Medical College, Huazhong University of Science and Technology
Wuhan, Hubei, 430022, China
Related Publications (6)
Yuan Q,Shen W,He W,Wang X,Liu F,Zhang Y,Lu X,Guan Z,Zhang J,Yang L
BACKGROUNDYang 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.
PMID: 40967653BACKGROUNDHussain 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.
PMID: 33975918BACKGROUNDLiao 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.
PMID: 41240971BACKGROUNDKim 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.
PMID: 35041742BACKGROUNDDesai 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.
PMID: 33426668BACKGROUND
Related Links
MeSH Terms
Interventions
Intervention Hierarchy (Ancestors)
Central Study Contacts
Study Design
- Study Type
- interventional
- Phase
- not applicable
- Allocation
- RANDOMIZED
- Masking
- QUADRUPLE
- Who Masked
- PARTICIPANT, CARE PROVIDER, INVESTIGATOR, OUTCOMES ASSESSOR
- Purpose
- TREATMENT
- Intervention Model
- PARALLEL
- Sponsor Type
- OTHER
- Responsible Party
- PRINCIPAL INVESTIGATOR
- PI Title
- Principal Investigator
Study Record Dates
First Submitted
March 28, 2026
First Posted
April 3, 2026
Study Start
April 9, 2026
Primary Completion (Estimated)
October 30, 2026
Study Completion (Estimated)
December 30, 2026
Last Updated
April 14, 2026
Record last verified: 2026-04
Data Sharing
- IPD Sharing
- Will not share
Data sharing is not permitted due to restrictions in the informed consent form and institutional policy. Participants did not provide consent for sharing their data beyond the primary study. Additionally, the Institutional Review Board has not approved a data sharing plan for this trial.