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CompletedNCT07509866Updated Oct 6, 2026

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

An interventional study of Liposomal bupivacaine (LB) and Ropivacaine with Perineural Dexamethasone in Total Knee Anthroplasty, Nerve Block and Ropivacaine, sponsored by Huazhong University of Science and Technology. Completed at 1 site in China. Open to participants aged 18 Years to 80 Years. Per ClinicalTrials.gov, last updated 2026-10-06.

Sponsored by Huazhong University of Science and Technology · Not applicable, Interventional, and Treatment

Updated Oct 6, 2026Now CompletedEnrollment updatedGo to Updates ↓
Phase
Not applicable
Study type
Interventional
Enrollment
90
Allocation
Randomized
Ages
18 Years to 80 Years
Sex
All
01

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.

02

Conditions studied

  • Total Knee Anthroplasty
  • Nerve Block
  • Ropivacaine
  • Liposomal Bupivacaine

Keywords

  • total knee arthroplasty
  • adductor canal block
  • IPACK block
  • liposomal bupivacaine
  • ropivacaine
  • perineural adjuncts
  • dexamethasone
  • dexmedetomidine
  • multimodal analgesia
03

In context

Lead sponsor

Huazhong University of Science and Technology is the lead sponsor of 247 studies on the registry; 62 are open to participants now.

Counted across the registry records on this site, refreshed daily.

04

Who can participate

Ages eligible
18 Years to 80 Years
Sexes eligible
All
Accepts healthy volunteers
No

Go through the criteria one by one — yes, no or not sure — and take the list to your doctor or the study team. Kept in this browser only.

Inclusion criteria

  • Patients scheduled for elective primary unilateral total knee arthroplasty
  • Age ≥ 18 years and ≤ 80 years
  • (ASA) physical status I-III
  • (BMI) ≥ 18 kg/m² and ≤ 35 kg/m²
  • Ability to understand and provide written

Exclusion criteria

Exclusion Criteria:

  • Known allergy or to local anesthetics (bupivacaine, ropivacaine), dexamethasone, dexmedetomidine, or opioids
  • Infection at the injection site
  • Coagulopathy or current use of anticoagulants
  • Severe cardiovascular disease ( [NYHA] functional class III or IV, or recent myocardial infarction within 6 months)
  • Severe hepatic impairment ( class C) or renal impairment (estimated [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 ( > 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)
Terms in these criteria, in plain language(8)

Underlined terms in the criteria open these too. Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.

ASA physical status

The anaesthetists’ scale of health before surgery: I is healthy, II has a mild illness that is under control, III a severe one, IV a severe illness that is a constant threat to life. V and VI are used for the critically ill and for organ donors.

BMI (body mass index)

Weight in kilograms divided by height in metres squared. Example: 70 kg and 1.75 m gives 70 ÷ (1.75 × 1.75) ≈ 22.9.

What counts as overweight or obesity differs between countries (some use lower cut-offs), so go by the range the study states.

Informed consent

Before you join, the study team explains what taking part involves — its purpose, what happens, the risks and possible benefits — and answers your questions, so you can decide freely. Consent is usually recorded on a form (the informed consent form, ICF) signed by you or, where the law allows, by someone legally authorised to decide for you.

You can keep asking questions during the study, you are told of new information that matters, and you can choose to leave at any time.

Contraindication

A reason a treatment, test or procedure should not be given to a particular person, such as an allergy, another illness or a medicine they take.

NYHA class (heart failure)

The New York Heart Association’s four classes of how much heart failure limits physical activity.

I
No limits: ordinary activity causes no undue tiredness or breathlessness.
II
Slight limits: comfortable at rest, ordinary activity causes symptoms.
III
Marked limits: comfortable at rest, less than ordinary activity causes symptoms.
IV
Symptoms even at rest; any activity makes them worse.

Studies set their own limit — many outside heart failure leave out class III–IV, while heart failure studies may ask for a particular class. Check the class this study names.

Child-Pugh class

A score of how well the liver works in people with liver disease such as cirrhosis: class A is mild, B moderate and C severe.

GFR and eGFR (kidney filtering)

GFR (glomerular filtration rate) is how much blood the kidneys filter each minute. It is usually estimated from a blood test — eGFR, by formulas such as CKD-EPI or MDRD — and some studies ask for it to be measured directly instead. Usually given in mL/min/1.73 m².

Check the method, the units and the minimum the study states. A value of 90 or above is in the normal-or-high range, but kidney damage can show in other tests too.

HbA1c

A blood test of average blood sugar over the past two to three months, given as a percentage or in mmol/mol. 6.5% (48 mmol/mol) or more is the usual threshold for diabetes, normally confirmed by a second test.

05

Study design

Phase
Not applicable
Primary purpose
Treatment
Allocation
Randomized
Intervention model
Parallel assignment
Masking
Quadruple (Participant, Care provider, Investigator, Outcomes assessor)
Enrollment
90 participants (actual)

Study arms

  • 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

    Drug: Liposomal bupivacaine (LB)

  • 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.

    Drug: Ropivacaine with Perineural Dexamethasone · Drug: Ropivacaine with Perineural Dexmedetomidine

Interventions

  • 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.

  • DrugRopivacaine 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

  • DrugRopivacaine 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

06

What researchers measure

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

  5. Quality of Recovery

    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.

    Time frame: Postoperative day 1-3

07

Study locations

1 site
  • Union Hospital, Tongji Medical College, Huazhong University of Science and Technology
    Wuhan, Hubei 430022, China
08

References and documents

Publications

  • Yuan Q, Shen W, He W, Wang X, Liu F, Zhang Y, Lu X, Guan Z, Zhang J, Yang L. Liposomal Bupivacaine for Adductor Canal Block Combined with IPACK Block in Total Knee Arthroplasty: A Prospective, Double-Blind, Randomized Controlled Trial. Drug Des Devel Ther. 2026 Jan 14;20:566411. doi: 10.2147/DDDT.S566411. eCollection 2026. PubMed 41858908 ↗
  • 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. PubMed 40967653 ↗
  • 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. PubMed 33975918 ↗
  • 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. 2026 Aug;41(8):2364-2371.e2. doi: 10.1016/j.arth.2025.11.015. Epub 2025 Nov 13. PubMed 41240971 ↗
  • 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. PubMed 35041742 ↗
  • 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. PubMed 33426668 ↗

Individual participant data

Plan to share: No — 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.

09

Updates

1 registry update since Sep 25, 2026
Status
Recruiting→Completed
changed Oct 6, 2026
Show all 1 update
  1. Oct 6, 2026
    Recruiting→Completed
    + 4 other changes: verification date, date precision, contact details and site details

From the registry record's own update history. This site started tracking changes on Sep 25, 2026; for anything earlier, see the record history on ClinicalTrials.gov ↗

10

Registry details

Key details

Study ID
NCT07509866
Responsible party
Xi Wu (Principal Investigator, Huazhong University of Science and Technology) — Principal investigator
First posted
Apr 3, 2026
Start date
Apr 9, 2026
Primary completion
Sep 4, 2026
Completion
Sep 8, 2026
Last update
Oct 6, 2026

Oversight

Data monitoring committee
No
FDA-regulated drug
No
FDA-regulated device
No
View the source record on ClinicalTrials.gov ↗

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Studies of the drug tested here: Liposomal Bupivacaine

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