NCT07509866

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

77
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
90

participants targeted

Target at P50-P75 for not_applicable

Timeline
7mo left

Started Apr 2026

Shorter than P25 for not_applicable

Geographic Reach
1 country

1 active site

Status
recruiting

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Progress25%
Apr 2026Dec 2026

First Submitted

Initial submission to the registry

March 28, 2026

Completed
6 days until next milestone

First Posted

Study publicly available on registry

April 3, 2026

Completed
6 days until next milestone

Study Start

First participant enrolled

April 9, 2026

Completed
7 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

October 30, 2026

Expected
2 months until next milestone

Study Completion

Last participant's last visit for all outcomes

December 30, 2026

Last Updated

April 14, 2026

Status Verified

April 1, 2026

Enrollment Period

7 months

First QC Date

March 28, 2026

Last Update Submit

April 9, 2026

Conditions

Keywords

total knee arthroplastyadductor canal blockIPACK blockliposomal bupivacaineropivacaineperineural adjunctsdexamethasonedexmedetomidinemultimodal analgesia

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

EXPERIMENTAL

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)

Ropivacaine with perineural adjuncts Group

ACTIVE COMPARATOR

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 DexamethasoneDrug: Ropivacaine with Perineural Dexmedetomidine

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

Ropivacaine with perineural adjuncts Group

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.

Liposomal Bupivacaine Group

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 adjuncts Group

Eligibility Criteria

Age18 Years - 80 Years
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)

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

RECRUITING

Related Publications (6)

  • Yuan Q,Shen W,He W,Wang X,Liu F,Zhang Y,Lu X,Guan Z,Zhang J,Yang L

    BACKGROUND
  • 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.

    PMID: 40967653BACKGROUND
  • 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.

    PMID: 33975918BACKGROUND
  • 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.

    PMID: 41240971BACKGROUND
  • 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.

    PMID: 35041742BACKGROUND
  • 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.

    PMID: 33426668BACKGROUND

Related Links

MeSH Terms

Interventions

Ropivacaine

Intervention Hierarchy (Ancestors)

AnilidesAmidesOrganic ChemicalsAniline CompoundsAmines

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.

Locations