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

Sponsor
The University of Hong Kong
Study ID
NCT06740214
Phase
PHASE3
Status
Recruiting
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Conditions

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

Eligibility Criteria

Sex
ALL
Age
18 Years - 80 Years
Healthy Volunteers
Not accepted

Interventions

  • 0.5% standard bupivacaine only — DRUG
    20ml 0.5% standard bupivacaine only
  • 1.33% liposomal bupivacaine with 0.5% standard bupivacaine — DRUG
    10ml 1.33% liposomal bupivacaine (133mg) plus 10ml 0.5% standard bupivacaine
  • 1.33% liposomal bupivacaine only — DRUG
    20ml 1.33% liposomal bupivacaine (266mg)

Study Details

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.

Key Dates

First listed
Dec 18, 2024
Start date
Sep 4, 2025
Status verified
Nov 2025
Primary completion
Jun 30, 2027
Completion
Jun 30, 2028

Study Design

Enrollment
177 participants (estimated)
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT

Arms

  • Active Comparator: ACB using 20ml 0.5% standard bupivacaine (SB-ACB)
    adductor canal block with 20ml 0.5% standard bupivacaine only
  • Experimental: ACB using 10ml 1.33% liposomal bupivacaine with 10 ml 0.5% standard bupivacaine (LB10-ACB)
    adductor canal block with 10ml 1.33% liposomal bupivacaine (133mg) plus 10ml 0.5% standard bupivacaine
  • Experimental: ACB using 20ml 1.33% liposomal bupivacaine only (LB20-ACB)
    adductor canal block with 20ml 1.33% liposomal bupivacaine (266mg)

Primary Outcome Measure

Weighted area under curve (AUC) pain score [ Time Frame: The first 48 hours after surgery when the patient is at rest ]

Central Contacts

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