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

StatusRecruiting
PhasePhase 3
Started
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Record History

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  1. Notable Trial status: Not Yet Recruiting to Recruiting
    • Start date changed from estimate of Jul 1, 2025 to Sep 4, 2025
    • Site details revised
    • Publications: details revised at 17 of 17 entries
    v4
  2. Minor Secondary endpoints: details revised at 1 of 19 entries
    • Eligibility criteria expanded, about 3 words
    v3
  3. Notable Primary completion date: Dec 31, 2026 to Jun 30, 2027
    • Start date: Jan 1, 2025 to Jul 1, 2025
    • Study completion date: Dec 31, 2027 to Jun 30, 2028
    v2
  4. Minor Study First Submitted
  • Stopped: an ongoing trial was terminated, suspended or withdrawn.
  • Notable: the trial’s plan changed such as a big move in its timeline or size, a new primary endpoint, sponsor or phase, or recruiting opened or resumed.
  • Minor: routine progress and housekeeping, such as sites added or enrollment closed.
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.
Trial Details
NCT Number NCT06740214
Lead Sponsor The University of Hong Kong
Conditions
(from sponsor)
Pain, Postoperative, Analgesic Effect, Total Knee Arthroplasty, Liposomal Bupivacaine, Dose Response Relationship, Drug
Related terms Postoperative Pain
Enrollment 177 participants
Start Date
Primary Completion (estimated)
Study Completion (estimated)
Updated on ClinicalTrials.gov