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Prospective RCT Lidocaine & Levobupivacaine on Block Dynamics After Subparaneural Popliteal Sciatic Nerve Block

StatusRecruiting
PhasePhase 4
Started
View on ClinicalTrials.gov ↗
Record status
This record was last updated April 13, 2025 (before its estimated September 30, 2026 completion). Its status may not reflect the trial's current state.

Record History

  1. Notable Primary and study completion dates: Sep 30, 2024 to Sep 30, 2026v12
  2. Notable Trial status: Not Yet Recruiting to Recruiting Primary and study completion dates: Sep 2024 to Sep 30, 2024 · Start date changed from estimate of Sep 1, 2023 to Sep 20, 2023 · Site details revisedv11 Show 3 more changesShow less
    • Primary and study completion dates: Sep 2024 to Sep 30, 2024
    • Start date changed from estimate of Sep 1, 2023 to Sep 20, 2023
    • Site details revised
  3. Notable Start date: Jun 1, 2023 to Sep 1, 2023 Primary completion date: Jun 2024 to Sep 2024 · Completion date: Jul 2024 to Sep 2024v10 Show 2 more changesShow less
    • Primary completion date: Jun 2024 to Sep 2024
    • Completion date: Jul 2024 to Sep 2024
  4. Notable Start date: Jan 1, 2023 to Jun 1, 2023 Primary completion date: Dec 2023 to Jun 2024 · Completion date: Jan 2024 to Jul 2024v9 Show 2 more changesShow less
    • Primary completion date: Dec 2023 to Jun 2024
    • Completion date: Jan 2024 to Jul 2024
  5. Notable Start date: Aug 1, 2022 to Jan 1, 2023v8
Show 6 earlier versionsHide 6 earlier versions
  1. Notable Primary completion date: Dec 2022 to Dec 2023 Start date: Dec 1, 2021 to Aug 1, 2022 · Trial status: Recruiting to Not Yet Recruiting · Completion date: Jan 2023 to Jan 2024 · 1 morev7 Show 4 more changesShow less
    • Start date: Dec 1, 2021 to Aug 1, 2022
    • Trial status: Recruiting to Not Yet Recruiting
    • Completion date: Jan 2023 to Jan 2024
    • Site details revised
  2. Notable Trial status: Not Yet Recruiting to Recruiting Study sites: 0 to 1 · Start date changed from estimate of Dec 2021 to Dec 1, 2021v6 Show 2 more changesShow less
    • Study sites: 0 to 1
    • Start date changed from estimate of Dec 2021 to Dec 1, 2021
  3. Notable Start date: Jun 2021 to Dec 2021v5
  4. Notable Primary completion date: Jun 4, 2022 to Dec 2022 Start date: Dec 2020 to Jun 2021 · Completion date: Jul 1, 2022 to Jan 2023v4 Show 2 more changesShow less
    • Start date: Dec 2020 to Jun 2021
    • Completion date: Jul 1, 2022 to Jan 2023
  5. Notable Start date: Jul 1, 2020 to Dec 2020v3
  6. Notable Start date: Jun 1, 2020 to Jul 1, 2020v2
  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.
Sciatic nerve block at the popliteal fossa is indicated for foot or ankle surgery, and the introduction of ultrasound guidance (USG) has improved the ease and accuracy of the performance of this block. Recent studies proved that subparaneural injection is associated with faster block onset, higher block success rate, and prolonged block duration suggesting subparaneural compartment of the sciatic nerve is a desirable site for local anaesthetic injection. Data from an ongoing trial in the investigator's institution comparing the block dynamics of subparaneural injection of 30ml 0.5% levobupivacaine (Chirocaine) above and below the bifurcation of the sciatic nerve at popliteal fossa has also shown that the time to 'readiness for surgery' was faster when the injection was performed below the bifurcation of the sciatic nerve. Lidocaine (Xylocaine) has a better pharmacokinetic and pharmacodynamics profile than levobupivacaine and is also widely used as local anaesthetic agent in clinical practice. Since there is no data comparing the block dynamics of lidocaine and levobupivacaine, this study aims to study and compare the block dynamics of lidocaine and levobupivacaine when given as a subparaneural injection below the bifurcation of the sciatic nerve at the popliteal fossa. In this study, the investigator hypothesizes that the use of lidocaine as the sole agent for this block will fasten the time to 'readiness for surgery' as compared to levobupivacaine when given as a subparaneural injection below the bifurcation of the sciatic nerve at the popliteal fossa.
Trial Details
NCT Number NCT04397484
Lead Sponsor Chinese University of Hong Kong
Conditions Musculoskeletal Diseases or Conditions
Enrollment 40 participants
Start Date
Primary Completion (estimated)
Study Completion (estimated)
Updated on ClinicalTrials.gov