Total Knee AnthroplastyNCT07509866
Liposomal Bupivacaine Versus Ropivacaine With Perineural Dexamethasone or Dexmedetomidine as Adjuncts for Adductor Canal Block Combined With IPACK Block in Total Knee Arthroplasty
A study testing Liposomal bupivacaine (LB), Ropivacaine with Perineural Dexamethasone and Ropivacaine with Perineural Dexmedetomidine in people with Total Knee Anthroplasty and Nerve Block, run by Huazhong University of Science and Technology at 1 site in China.
Trial 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. Read more about this study
- Who is it for?
- Ages 18 to 80 years
- Conditions the study is for
- Total Knee Anthroplasty, Nerve Block, Ropivacaine
- What is being tested?
- Liposomal bupivacaine (LB), Ropivacaine with Perineural Dexamethasone and Ropivacaine with Perineural Dexmedetomidine
- Type of treatment
- Pill or oral medicine, Injection or infusion
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 90 participants
- Where
- 1 siteChina
- Study dates
- 9 Apr 2026to 8 Sep 2026
- Phase
- Interventional
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 to 80 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- 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
Who cannot join
- 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)
Show all 11Show fewer
- 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)
Trial locations and contacts
1 site in 1 country.
China1 site
Union Hospital, Tongji Medical College, Huazhong University of Science and Technology
Wuhan, Hubei, 430022
About this study
Official title: 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.
- Being tested
- Liposomal bupivacaine (LB), Ropivacaine with Perineural Dexamethasone, Ropivacaine with Perineural Dexmedetomidine
- Keywords
- total knee arthroplasty, adductor canal block, IPACK block, liposomal bupivacaine, ropivacaine, perineural adjuncts, dexamethasone, dexmedetomidine, multimodal analgesia
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
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 DexamethasoneDrug
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 DexmedetomidineDrug
Ropivacaine 0.375% with dexmedetomidine 1 μg/kg (actual body weight). Total 40 mL (20 mL per block) via ultrasound-guided ACB and IPACK
| Study group | Role | What they receive |
|---|---|---|
| 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 Receives: 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. Receives: Drug: Ropivacaine with Perineural Dexamethasone; Drug: Ropivacaine with Perineural Dexmedetomidine |
What is being measured
The primary outcome is the main question the study is designed to answer.
Total opioid consumption
Total postoperative opioid consumption within 72 hour after surgery.
Measured: 72 hours
Secondary outcomes (5)
Pain scores at rest and during movement
Visual Analog Scale (VAS, 0-100 mm) within 72 hour postoperatively.
Measured: 72 hours
Time to First Ambulation
Time from arrival in PACU to first ambulation
Measured: Postoperative day 0-2
Duration of Hospital Stay
Time from surgery to hospital discharge, measured in days.
Measured: 0-30 days
Patient Satisfaction with Pain Management
Patient satisfaction assessed using a 5-point Likert scale (1 = very dissatisfied, 5 = very satisfied).
Measured: 24 hours, 48 hours and 27 hours postoperatively
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.
Measured: Postoperative day 1-3
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted3 Apr 2026
- Study start9 Apr 2026
- Primary completion4 Sep 2026
- Study completion8 Sep 2026
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (6)Papers the sponsor has linked to this study.
- Other trials for Total Knee AnthroplastyStudies of the same condition, open and under way.
- More trials run by Huazhong University of Science and TechnologyThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Quadruple blind
- Who is masked
- Participant, Care provider, Investigator, Outcomes assessor
- Enrolment
- 90 participants (actual)
Sponsor and investigators
- Lead sponsor
- Huazhong University of Science and Technology
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Xi Wu, Huazhong University of Science and Technology
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT07509866
- Sponsor's protocol ID
- WHUH20260327
- Status last verified
- Oct 2026
- First submitted
- 28 Mar 2026
- Last updated
- 6 Oct 2026
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- 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.
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 41858908Yang 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 40967653Hussain 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 33975918Liao 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 41240971Kim 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 35041742Desai 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
Study at a glance
From the registry record, last updated by the sponsor on 6 Oct 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- 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
- ClinicalTrials.gov ID
- NCT07509866
- Acronym / sponsor ID
- WHUH20260327
- Keywords
- total knee arthroplasty, adductor canal block, IPACK block, liposomal bupivacaine, ropivacaine, perineural adjuncts, dexamethasone, dexmedetomidine
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 90 participants (actual)
- Lead sponsor
- Huazhong University of Science and TechnologyUniversity, hospital or other
- Study start
- 9 Apr 2026 (actual)
- Primary completion
- 4 Sep 2026 (actual)
- Study completion
- 8 Sep 2026 (actual)
- First posted
- 3 Apr 2026 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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 design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Quadruple blind (participant, care provider, investigator, outcomes assessor)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Liposomal Bupivacaine Group | Experimental | Drug: Liposomal bupivacaine (LB)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 |
| Ropivacaine with perineural adjuncts Group | Active comparator | Drug: Ropivacaine with Perineural Dexamethasone, Drug: Ropivacaine with Perineural DexmedetomidineParticipants 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. |
Who may qualify
- Ages
- 18 to 80 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (5 listed)
- 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
Key exclusion criteria (11 listed)
- 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)
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Liposomal bupivacaine (LB)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. | Drug | Liposomal Bupivacaine Group |
| Ropivacaine with Perineural DexamethasoneRopivacaine 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 | Drug | Ropivacaine with perineural adjuncts Group |
| Ropivacaine with Perineural DexmedetomidineRopivacaine 0.375% with dexmedetomidine 1 μg/kg (actual body weight). Total 40 mL (20 mL per block) via ultrasound-guided ACB and IPACK | Drug | Ropivacaine with perineural adjuncts Group |
Primary outcome
Total opioid consumption
Time frame: 72 hours
Total postoperative opioid consumption within 72 hour after surgery.
5 secondary outcomes
Pain scores at rest and during movement
Time frame: 72 hours
Time to First Ambulation
Time frame: Postoperative day 0-2
Duration of Hospital Stay
Time frame: 0-30 days
Patient Satisfaction with Pain Management
Time frame: 24 hours, 48 hours and 27 hours postoperatively
Quality of Recovery
Time frame: Postoperative day 1-3
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 6 Oct 2026.
- Background: PubMed 41858908Yuan 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.
- Background: PubMed 40967653Yang 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.
- Background: PubMed 33975918Hussain 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.
- Background: PubMed 41240971Liao 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.
- Background: PubMed 35041742Kim 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.
- Background: PubMed 33426668Desai 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.
- Related InfoLink provided by the sponsor.
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- Related InfoLink provided by the sponsor.
- Individual participant dataSharing planned: 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.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
The record lists no contact. Use the official record to reach the sponsor.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Liposomal bupivacaine (LB), Ropivacaine with Perineural Dexamethasone and Ropivacaine with Perineural Dexmedetomidine in people with Total Knee Anthroplasty and Nerve Block, run by Huazhong University of Science and Technology at 1 site in China.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 5 inclusion and 11 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 6 Oct 2026. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in China. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Total opioid consumption (time frame: 72 hours). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT07509866, which also lists 6 linked publications.
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 6 Oct 2026.