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

NCT06740214 · Status: RECRUITING · Phase: PHASE3 · Type: INTERVENTIONAL · Enrollment: 177

Last updated 2025-11-24

No results posted yet for this study

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. 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.

Conditions

  • Pain, Postoperative
  • Analgesic Effect
  • Total Knee Arthroplasty
  • Liposomal Bupivacaine
  • Dose Response Relationship, Drug

Interventions

DRUG

0.5% standard bupivacaine only

20ml 0.5% standard bupivacaine only

DRUG

1.33% liposomal bupivacaine with 0.5% standard bupivacaine

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

DRUG

1.33% liposomal bupivacaine only

20ml 1.33% liposomal bupivacaine (266mg)

Sponsors & Collaborators

  • The University of Hong Kong

    lead OTHER

Study Design

Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
TRIPLE
Model
PARALLEL

Eligibility

Min Age
18 Years
Max Age
80 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2025-09-04
Primary Completion
2027-06-30
Completion
2028-06-30

Countries

  • Hong Kong

Study Locations

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Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT06740214 on ClinicalTrials.gov