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Pain, PostoperativePhase 3NCT06740214

Analgesic Efficacy of Different Liposomal Bupivacaine Doses in the Adductor Canal Block for Total Knee Arthroplasty

A Phase 3 study testing 0.5% standard bupivacaine only, 1.33% liposomal bupivacaine with 0.5% standard bupivacaine and 1.33% liposomal bupivacaine only in people with Pain, Postoperative and Analgesic Effect, run by The University of Hong Kong at 1 site in Hong Kong.

Recruiting

Looking for participants now. Contact the study team or a site below to ask about taking part.

Sites and contacts
Official record
Search all trials

Trial summary

Total knee arthroplasty is a commonly performed orthopaedic surgery for the treatment of end-stage osteoarthritis when conservative management becomes ineffective. TKA is associated with significant acute postoperative pain and many patients experience severe postoperative pain despite the use of multimodal analgesia. Read more about this study

Who is it for?
Ages 18 to 80 years
What is being tested?
0.5% standard bupivacaine only, 1.33% liposomal bupivacaine with 0.5% standard bupivacaine and 1.33% liposomal bupivacaine only
Could I receive a placebo?
No, everyone receives an active treatment
How many people
177 participants
Where
1 siteHong Kong
Study dates
4 Sep 2025to 30 Jun 2028
Phase
Phase 3
Are there results?
Not yet: the study is under way

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

  • ASA I-III
  • Age 18-80 years old
  • Scheduled for elective primary unilateral total knee arthroplasty (TKA) with robotic surgery
  • Able to speak and understand Cantonese or Mandarin or English
  • Able to provide informed oral and written consent

Who cannot join

  • Revision TKA
  • Single-stage bilateral TKA
  • Complex primary TKA requiring use of stem/augment/constrained liner
  • Surgeries with significant intraoperative complications which may alter rehabilitation protocol eg collateral ligament injury, fracture requiring fixation
  • Known allergy to opioids, local anaesthetic drugs, paracetamol, non-steroidal anti-inflammatory drugs (NSAIDS) including COX-2 inhibitors
  • History of chronic pain other than chronic knee pain
Show all 22Show fewer
  • History of immunosuppression
  • Chronic use of glucocorticoids
  • Chronic opioid use (morphine, fentanyl, hydromorphone, ketobemidone, methadone, nicomorphine, oxycodone, or meperidine)
  • History of congestive heart failure (NYHA 2)
  • Alcohol or drug abuse
  • Impaired renal function (defined as effective glomerular filtration rate < 30ml/min/1.73m2
  • Impaired liver function (defined as plasma bilirubin over 34mol/L; international normalized ratio [INR] >= 1.7, alanine aminotransferase [ALT] over 100U/L, aspartate aminotransferase [AST] over 100U/L)
  • Coagulopathy (platelet count <100,000/ml and/or INR >= 1.5) or the use of anticoagulants (not including aspirin) that precludes the use of adductor canal blocks
  • Pre-existing neurological or muscular disorders
  • Psychiatric illness
  • Impaired mental state
  • Pregnancy
  • Local infection
  • On immunosuppressants
  • High body mass index (BMI) (>=40)
  • Patient refusal for regional nerve blocks or to conduct clinical trial

Trial locations and contacts

1 site in 1 country. Contact the study team or a site near you to ask about taking part.

Stanley S.C. WONG, MD (HKU) contact

(852) 2255 3303

wongstan@hku.hk

Hong Kong1 site, 1 recruiting

  • The University of Hong Kong

    Hong Kong, Hong Kong

    Stanley S.C. Wong, MD (HKU), (852) 2255 3303, wongstan@hku.hk

    Recruiting

Other trials in Hong Kong

About this study

Official title: Analgesic Efficacy of Different Liposomal Bupivacaine Doses in the Adductor Canal Block for Total Knee Arthroplasty: a Randomized Controlled Trial

Total knee arthroplasty is a commonly performed orthopaedic surgery for the treatment of end-stage osteoarthritis when conservative management becomes ineffective. TKA is associated with significant acute postoperative pain and many patients experience severe postoperative pain despite the use of multimodal analgesia. Poor acute postoperative pain control impacts rehabilitation, prolongs recovery and increases opioid consumption and chronic post-surgical pain.

Liposomal bupivacaine (Exparel, Pacira Pharmaceuticals Inc, Parsippany, New Jersey, USA) is a multivesicular formulation of bupivacaine that prolongs drug release and can extend the duration of analgesia. The adductor canal block (ACB) has been shown to reduce pain intensity and opioid consumption after total knee arthroplasty. The use of liposomal bupivacaine in the adductor canal block has recently been FDA-approved. However, the results of its efficacy from existing clinical trials have been mixed. In addition, the doses in the clinical trials have been different, and the optimal dose for perineural application of liposomal bupivacaine is unclear, including for the adductor canal block.

In this project, the investigators propose to conduct a randomized controlled trial to investigate the effect of different doses of liposomal bupivacaine in the adductor canal block on acute postoperative pain intensity and opioid consumption after robotic assisted total knee arthroplasty. The investigators will also assess secondary outcomes including knee functional scores, chronic pain and quality of recovery.

Being tested
0.5% standard bupivacaine only, 1.33% liposomal bupivacaine with 0.5% standard bupivacaine, 1.33% liposomal bupivacaine only
Keywords
adductor canal block, local infiltration analgesia, liposomal bupivacaine, opioid consumption, total knee arthroplasty
Medical subject headings
Pain, Postoperative

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

  • 0.5% standard bupivacaine onlyDrug

    20ml 0.5% standard bupivacaine only

  • 1.33% liposomal bupivacaine with 0.5% standard bupivacaineDrug

    10ml 1.33% liposomal bupivacaine (133mg) plus 10ml 0.5% standard bupivacaine

  • 1.33% liposomal bupivacaine onlyDrug

    20ml 1.33% liposomal bupivacaine (266mg)

Study groups in NCT06740214
Study groupRoleWhat they receive
ACB using 20ml 0.5% standard bupivacaine (SB-ACB)Active comparatoradductor canal block with 20ml 0.5% standard bupivacaine only
Receives: Drug: 0.5% standard bupivacaine only
ACB using 10ml 1.33% liposomal bupivacaine with 10 ml 0.5% standard bupivacaine (LB10-ACB)Experimentaladductor canal block with 10ml 1.33% liposomal bupivacaine (133mg) plus 10ml 0.5% standard bupivacaine
Receives: Drug: 1.33% liposomal bupivacaine with 0.5% standard bupivacaine
ACB using 20ml 1.33% liposomal bupivacaine only (LB20-ACB)Experimentaladductor canal block with 20ml 1.33% liposomal bupivacaine (266mg)
Receives: Drug: 1.33% liposomal bupivacaine only

What is being measured

The primary outcome is the main question the study is designed to answer.

  1. Weighted area under curve (AUC) pain score

    Pain severity would be rated at rest after surgery using numerical rating scale (NRS) with 0 to 10 where 0=no pain and 10=the worst possible pain

    Measured: The first 48 hours after surgery when the patient is at rest

Secondary outcomes (19)

  1. NRS pain scores

    NRS pain scores at rest and with movement (active knee flexion) from after surgery to postoperative day (POD) 7, ranging 0-10, with higher scores indicating more severe pain.

    Measured: from after surgery to postoperative day 7

  2. Oxynorm consumption

    Oxynorm consumption from postoperative day (POD) 1-7

    Measured: Postoperative day 1-7

  3. Overall Benefit of Analgesic Score (OBAS)

    Overall Benefit of Analgesic Score (OBAS) from postoperative day (POD) 1-7 (range, 0 [best] to 28 [worst])

    Measured: Postoperative day (POD) 1-7

  4. Plasma level of bupivacaine and ropivacaine

    Plasma level of bupivacaine and ropivacaine before and after surgery

    Measured: Blood will be collected during induction, at 12 hours, 24 hours, 48 hours, and 72 hours after ACB.

  5. Quality of Recovery Questionnaire (QoR-9)

    Quality of Recovery Questionnaire (QoR-9) on postoperative day 1, ranging from 0 to 18, with higher scores indicating good recovery after anaesthesia.

    Measured: Postoperative day 1

  6. Rehabilitation parameters (range of maximal active knee flexion)

    Range of maximal active knee flexion will be assessed by the physiotherapists while the patient is in hospital.

    Measured: While the patient is in hospital from postoperative day 0, day 1, and day 2.

  7. Rehabilitation parameters (quadricep power)

    Quadricep power will be assessed by the physiotherapists while the patient is in hospital.

    Ratings:

    0 - no muscle contraction

    1. - Move w/o gravity
    2. - Raise then drop down immediately
    3. - Raise against gravity w/o resistance
    4. - Raise against gravity w/some resistance
    5. - Raise against gravity w/ full resistance

    Measured: While the patient is in hospital from postoperative day 0, day 1, and day 2.

  8. Rehabilitation parameters (ability to perform straight leg raising)

    Ability to perform straight leg raising will be assessed by the physiotherapists while the patient is in hospital. Ratings (Yes/ No).

    Measured: While the patient is in hospital from postoperative day 0, day 1, and day 2.

  9. Rehabilitation parameters (walking distance)

    Walking distance (in metres) will be assessed by the physiotherapists while the patient is in hospital.

    Measured: While the patient is in hospital from postoperative day 0, day 1, and day 2.

  10. Rehabilitation parameters (Duration of hospital stay)

    No. of hospitalization days from admission to discharge

    Measured: estimated on average of postoperative day 7 at the date of discharge from hospital

  11. Rehabilitation parameters (discharge location)

    Home or rehabilitation center

    Measured: estimated on average of postoperative day 7 at the date of discharge from hospital

  12. Opioid-related side effects

    Presence or absence of pruritus, dizziness, nausea, and vomiting will be recorded.

    Measured: While the patient is in hospital from postoperative day 0, 1, and 2.

  13. Potential side effects related to adductor canal block (ACB)

    Presence or absence of local anaesthetic toxicity, neurological injury, and intravascular injection will be recorded.

    Measured: While the patient is in hospital from postoperative day 0, 1, and 2.

  14. Analgesic block duration

    Measured in time to return of pain (When did your pain relief from the block completely wear off?), time to sensory resolution (When did your numbness completely resolve and return to normal?), and time to motor resolution (When did your arm or hand weakness resolve and return to normal?)

    Measured: While the patient is in hospital at postoperative day 1

  15. Sensory and motor assessment

    The affected lower limb will be measured.

    Sensory assessment (Sensation to pin prick), rating from 0 (no sensation) to 10 (normal sensation)

    Motor assessment

    • Straight leg raising achieved Ratings (Yes/ No)
    • Quadriceps power

    Ratings:

    0 - no muscle contraction

    1. - Move w/o gravity
    2. - Raise then drop down immediately
    3. - Raise against gravity w/o resistance
    4. - Raise against gravity w/some resistance
    5. - Raise against gravity w/ full resistance

    Measured: While the patient is in hospital from post-block 2 hours, 6 hours, 12 hours, and 24 hours.

  16. quality of life (SF12v2)

    Eight domains of SF-12v2 (HK) are measured on a scale ranging from 0 to 100. A higher domain score indicates a better HRQoL.

    Measured: at 6 weeks and at 3 and 6 months after surgery

  17. Identification Pain Questionnaire for Neuropathic Pain (ID-NeP)

    Neuropathic pain will be assessed using Identification Pain Questionnaire for Neuropathic Pain (ID-NeP), consisting of six items: "Yes" answers to questions 1-5 were given a score of 1, while "yes" answer to question 6 scored -1. "No" answers to questions 1-5 were given a score of 0, while "yes" answer to question 6 scored 0.

    Measured: at 6 weeks, 3 months and 6 months postoperatively

  18. Knee Society Knee Function Score

    Knee Society Knee Function Score at 6 weeks, 3 months and 6 months postoperatively, from 0 to 100 with lower scores being indicative of worse knee conditions and higher scores being indicative of better knee conditions.

    Measured: at 6 weeks, 3 months and 6 months postoperatively

  19. Chronic post-surgical pain

    The presence or absence of chronic post-surgical pain, pain scores if present.

    Measured: at 6 weeks, 3 months and 6 months postoperatively

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

  1. First posted18 Dec 2024
  2. Study start4 Sep 2025
  3. Primary completion30 Jun 2027 (estimated)
  4. Study completion30 Jun 2028 (estimated)

Resources

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 3
Primary purpose
Treatment
Allocation
Randomised
Intervention model
Parallel groups
Masking
Triple blind
Who is masked
Participant, Investigator, Outcomes assessor
Enrolment
177 participants (estimated)
IDs, dates and publications
ClinicalTrials.gov ID
NCT06740214
Sponsor's protocol ID
UW24-691
Status last verified
Nov 2025
First submitted
29 Nov 2024
Last updated
24 Nov 2025
Results posted
No
Data monitoring committee
No
FDA-regulated drug
No
FDA-regulated device
No

Publications

  • Culliton SE, Bryant DM, MacDonald SJ, Hibbert KM, Chesworth BM. Validity and Internal Consistency of the New Knee Society Knee Scoring System. Clin Orthop Relat Res. 2018 Jan;476(1):77-84. doi: 10.1007/s11999.0000000000000014.

    PubMed 29529620

  • Portenoy R. Development and testing of a neuropathic pain screening questionnaire: ID Pain. Curr Med Res Opin. 2006 Aug;22(8):1555-65. doi: 10.1185/030079906X115702.

    PubMed 16870080

  • Chan MT, Lo CC, Lok CK, Chan TW, Choi KC, Gin T. Psychometric testing of the Chinese quality of recovery score. Anesth Analg. 2008 Oct;107(4):1189-95. doi: 10.1213/ane.0b013e318184b94e.

    PubMed 18806027

  • Lam ET, Lam CL, Fong DY, Huang WW. Is the SF-12 version 2 Health Survey a valid and equivalent substitute for the SF-36 version 2 Health Survey for the Chinese? J Eval Clin Pract. 2013 Feb;19(1):200-8. doi: 10.1111/j.1365-2753.2011.01800.x. Epub 2011 Nov 29.

    PubMed 22128754

  • Lehmann N, Joshi GP, Dirkmann D, Weiss M, Gulur P, Peters J, Eikermann M. Development and longitudinal validation of the overall benefit of analgesia score: a simple multi-dimensional quality assessment instrument. Br J Anaesth. 2010 Oct;105(4):511-8. doi: 10.1093/bja/aeq186. Epub 2010 Aug 6.

    PubMed 20693179

  • Cohen, J., Statistical power analysis for the behavioral sciences. 2013: routledge.

  • Quaye A, McAllister B, Garcia JR, Nohr O, Laduzenski SJ, Mack L, Kerr CR, Kerr DA, Razafindralay CN, Richard JM, Craig WY, Rodrigue S. A prospective, randomized trial of liposomal bupivacaine compared to conventional bupivacaine on pain control and postoperative opioid use in adults receiving adductor canal blocks for total knee arthroplasty. Arthroplasty. 2024 Feb 1;6(1):6. doi: 10.1186/s42836-023-00226-y.

    PubMed 38297390

  • Malige A, Pellegrino AN, Kunkle K, Konopitski AK, Brogle PJ, Nwachuku CO. Liposomal Bupivacaine in Adductor Canal Blocks Before Total Knee Arthroplasty Leads to Improved Postoperative Outcomes: A Randomized Controlled Trial. J Arthroplasty. 2022 Aug;37(8):1549-1556. doi: 10.1016/j.arth.2022.03.073. Epub 2022 Mar 26.

    PubMed 35351553

  • Hungerford M, Neubauer P, Ciotola J, Littleton K, Boner A, Chang L. Liposomal Bupivacaine vs Ropivacaine for Adductor Canal Blocks in Total Knee Arthroplasty: A Prospective Randomized Trial. J Arthroplasty. 2021 Dec;36(12):3915-3921. doi: 10.1016/j.arth.2021.08.017. Epub 2021 Aug 21.

    PubMed 34556382

  • Hubler CP, Bevil KM, Greiner JJ, Hetzel SJ, Borden SB, Cios HA. Liposomal Bupivacaine Versus Standard Bupivacaine in the Adductor Canal for Total Knee Arthroplasty: A Randomized, Controlled Trial. Orthopedics. 2021 Jul-Aug;44(4):249-255. doi: 10.3928/01477447-20210621-01. Epub 2021 Jul 1.

    PubMed 34292820

  • Lv J, Huang C, Wang Z, Ou S. Adductor canal block combined with local infiltration analgesia versus isolated adductor canal block in reducing pain and opioid consumption after total knee arthroplasty: a systematic review and meta-analysis. J Int Med Res. 2020 Aug;48(8):300060520926075. doi: 10.1177/0300060520926075.

    PubMed 32776794

  • Li Y, Li A, Zhang Y. The efficacy of combined adductor canal block with local infiltration analgesia for pain control after total knee arthroplasty: A meta-analysis. Medicine (Baltimore). 2018 Dec;97(49):e13326. doi: 10.1097/MD.0000000000013326.

    PubMed 30544393

  • Zuo W, Guo W, Ma J, Cui W. Dose adductor canal block combined with local infiltration analgesia has a synergistic effect than adductor canal block alone in total knee arthroplasty: a meta-analysis and systematic review. J Orthop Surg Res. 2019 Apr 11;14(1):101. doi: 10.1186/s13018-019-1138-5.

    PubMed 30971284

  • Ilfeld BM, Eisenach JC, Gabriel RA. Clinical Effectiveness of Liposomal Bupivacaine Administered by Infiltration or Peripheral Nerve Block to Treat Postoperative Pain. Anesthesiology. 2021 Feb 1;134(2):283-344. doi: 10.1097/ALN.0000000000003630.

    PubMed 33372949

  • Jiang X, Wang QQ, Wu CA, Tian W. Analgesic Efficacy of Adductor Canal Block in Total Knee Arthroplasty: A Meta-analysis and Systematic Review. Orthop Surg. 2016 Aug;8(3):294-300. doi: 10.1111/os.12268.

    PubMed 27627711

Questions about this trial

What is this clinical trial studying?

A Phase 3 study testing 0.5% standard bupivacaine only, 1.33% liposomal bupivacaine with 0.5% standard bupivacaine and 1.33% liposomal bupivacaine only in people with Pain, Postoperative and Analgesic Effect, run by The University of Hong Kong at 1 site in Hong Kong.

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 22 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: looking for participants now, as of the sponsor's last update on 24 Nov 2025. 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 Hong Kong. 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.

What does this phase mean?

Phase 3 studies compare the treatment with the current standard treatment or a placebo in a large group, to confirm how well it works and watch for side effects.

Not every study follows the same path, and some studies (observational studies, device studies) have no phase.

Are results available for this study?

This study is still under way. Results are not available in the source record yet.

How can a doctor refer a patient or contact the research team?

Contact Stanley S.C. WONG, MD (HKU) ((852) 2255 3303, wongstan@hku.hk), or a site near the patient. AzTrials does not enrol participants or take referrals.

What does the primary outcome measure?

Weighted area under curve (AUC) pain score (time frame: The first 48 hours after surgery when the patient is at rest). 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 NCT06740214, which also lists 17 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 24 Nov 2025.

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