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Effectiveness of Adductor Canal Block Using Liposomal Bupivacaine

StatusNot Yet Recruiting
PhasePhase 4
Started
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Record History

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  1. Notable Primary and study completion dates: Oct 2024 to Oct 2026
    • Start date: Nov 1, 2023 to Mar 1, 2024
    v10
  2. Notable Start date: Aug 1, 2023 to Nov 1, 2023
    • Primary endpoints: 2 to 1
    • Eligibility criteria expanded, about 7 words
    • Secondary endpoints: 4 to 5
    v9
  3. Notable Primary and study completion dates: Oct 2023 to Oct 2024v8 Show 4 more changesShow less
    • Start date: May 1, 2023 to Aug 1, 2023
    • Trial status: Enrolling by Invitation to Not Yet Recruiting
    • Interventions: Liposomal bupivacaine (Drug), normal Saline (Drug) to Bupivacaine Injection (Drug), Liposomal bupivacaine (Drug)
    • Site contact updated
  4. Notable Start date: Dec 1, 2020 to May 1, 2023
    • Trial status: Recruiting to Enrolling by Invitation
    • Interventions: Bupivacaine Injection (Drug), Liposomal bupivacaine (Drug) to Liposomal bupivacaine (Drug), normal Saline (Drug)
    • Site details revised
    v7
  5. Notable Primary and study completion dates: Oct 2021 to Oct 2023v6
Show 4 earlier versionsHide 4 earlier versions
  1. Notable Trial status: Not Yet Recruiting to Recruiting
    • Start date changed from estimate of Dec 2020 to Dec 1, 2020
    • Site details revised
    v5
  2. Notable Start date: Oct 2020 to Dec 2020v4
  3. Notable Primary and study completion dates: Oct 2020 to Oct 2021
    • Start date: Oct 2019 to Oct 2020
    • Interventions: Liposomal bupivacaine (Drug), Saline (Drug) to Bupivacaine Injection (Drug), Liposomal bupivacaine (Drug)
    v3
  4. Notable Start date: Aug 2019 to Oct 2019
    • Primary and study completion dates: Aug 2020 to Oct 2020
    v2
  1. 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  • Stopped: an ongoing trial was terminated, suspended or withdrawn.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.
With aging of population, osteoarthritis of knees and hips become major orthopaedic problems in Hong Kong. Osteoarthritis of knees and hips are associated with significant pain problem and functional disability. Total joints replacement is the ultimate surgical procedures to deal with such problems. However total joints replacement is associated with significant tissue damage and post-operative pain problems, which would affect post-operative recovery and rehabilitation. The primary aims of total knee replacement are improvement in functional activities and reduce pain due to degenerated knee joints. However, there are around 20-30% of patients would develop significant pain problem despite uncomplicated total knee replacement. It accounts for major post-operative problems and burdens. Procedure specific analgesic method with multi-model analgesia technique is well-known to be useful in post-operative pain management, which reduces the post-operative pain score. However, despite using of multi-modal analgesic technique, pain after total joint replacement is still the most unsolved issue. It prolongs the recovery period and increases post-operative analgesic consumptions. Multimodal analgesia, including periarticular local infiltration of analgesia (LIA), regional nerve block, opioid and non-opioid have been shown to be effective in managing postoperative pain. Periarticular LIA has been shown to be an effective way of pain management. Regional nerve block using femoral nerve block or adductor canal block (ACB) is also a well-established anlagesic technique after total knee replacement. Comparing with femoral nerve block, it involves more sensory blockade so has the advantage of quadriceps sparing, less affecting the post-operative mobilization. From most recent systematic reviews and randomized controlled trials, it becomes clear that periarticular LIA has better pain control with less opioid consumption than ACB alone. However, duration of a single-dose LIA may not be long enough after total knee replacement. Recent meta-analysis has shown that combined ACB with LIA could significantly reduce pain scores and morphine consumption compared LIA alone after TKA. Standard bupivacaine, levobupivocaine, ropivocaine were used in ACB in these studies. They are local anaesthetic with half-life ranging from 3-6 hours. With the availability of liposomal bupivacaine (LB), ACB using LB may further prolong the analgesic effect of ACB as the therapeutic levels of bupivacaine, which are below the toxic range and sustained for 72 hours after injection. Therefore, the issue is whether ACB using LB has even longer analgesic effect than plain bupivacaine or ropivacaine. There was only one study directly compared ACB using LB and 0.1% ropivociane infusion. It was shown that LB had significant impact in pain control in the first 36 hours. However, this was a retrospective study and there was difference in delivery of local anaesthetics (single shot injection for liposomal bupivacaine but continuous infusion for ropivacaine). The primary aim of this study is to investigate whether ACB using liposomal bupivacaine has even longer analgesic effect than standard bupivacaine (SB) and its cost effectiveness. Secondary aims are to evaluate the pharmacokinetic data of standard bupivacaine and liposomal bupivacaine in adductor canal block and pharmacokinetic data of ropivocaine level in LIA.
Trial Details
NCT Number NCT04003506
Lead Sponsor The University of Hong Kong
Conditions
(from sponsor)
Pain, Postoperative
Related terms Acute Pain, Postoperative Pain
Enrollment 90 participants
Start Date
Primary Completion (estimated)
Study Completion (estimated)
Updated on ClinicalTrials.gov