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Intralipid® 20% for Reversal of Local Anesthetics

StatusActive, Not Recruiting
PhasePhase 4
Started
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Record History

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  1. Primary completion date: Oct 2025 to Oct 2026v13
  2. Trial status: Recruiting to Active, Not Recruiting
    • Site details revised
    v12
  3. Primary completion date: Oct 2024 to Oct 2025
    • Study completion date: Oct 2025 to Oct 2026
    • Site contact updated
    v11
  4. Primary completion date: Jan 23, 2024 to Oct 2024
    • Study completion date: Jan 23, 2025 to Oct 2025
    v10
  5. Primary endpoints: 1 to 4v9 Show 7 more changesShow less
    • Trial status: Enrolling by Invitation to Recruiting
    • Primary completion date: Nov 23, 2023 to Jan 23, 2024
    • Study completion date: Nov 23, 2024 to Jan 23, 2025
    • Interventions: Lidocaine 2% Injectable Solution, Lidocaine 1% Injectable Solution, Bupivacaine 0.25% injectable solution, Bupivacaine 0.5% injectable… to Bupivacaine 0.25% (Drug), Bupivacaine 0.5% (Drug), Intralipid, 20% Intravenous (Drug), Lidocaine 1% (Drug), Lidocaine 2% (Drug), Saline…
    • Secondary endpoints: 4 to 8
    • Site details revised
    • Study title shortened, about 14 words
Show 7 earlier versionsHide 7 earlier versions
  1. Primary completion date: Nov 1, 2022 to Nov 23, 2023
    • Study completion date: Dec 1, 2022 to Nov 23, 2024
    v8
  2. Primary completion date: Mar 1, 2022 to Nov 1, 2022v7
  3. Primary completion date: Sep 1, 2021 to Mar 1, 2022
    • Study completion date: Sep 1, 2021 to Dec 1, 2022
    v6
  4. Re-verified, no change to tracked fieldsv5
  5. Primary completion date: Sep 1, 2020 to Sep 1, 2021
    • Study completion date: Jun 1, 2021 to Sep 1, 2021
    v4
  6. Secondary endpoints: details revised at 4 of 4 entriesv3
  7. Trial status: Not Yet Recruiting to Enrolling by Invitation
    • Study sites: 0 to 1
    • Primary completion date: Jun 1, 2020 to Sep 1, 2020
    • Start date changed from estimate of Jun 1, 2019 to Jul 26, 2019
    v2
  1. 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  • Stopped: an ongoing trial was terminated, suspended or withdrawn.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.
In order to determine if Intralipid 20% can be used to reverse the effects of local anesthetics, the investigators will recruit 18 volunteers who will be asked to come to HSS for two study visits. Small amounts of local anesthetics will be injected into the volunteers' thighs during both visits. During one visit volunteers will receive Intralipid 20% and during the other visit they will receive a saline solution. The study team will measure how quickly normal sensation returns to the thighs when the volunteers get Intralipid 20% compared to saline.
Trial Details
NCT Number NCT03968822
Lead Sponsor Hospital for Special Surgery, New York
Conditions
(from sponsor)		 Anesthesia, Local
Enrollment 18 participants
Start Date
Primary Completion (estimated)
Study Completion (estimated)
Updated on ClinicalTrials.gov