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Intravenous Lidocaine Infusion in Lumbar Fusion Surgery

StatusRecruiting
PhaseNot applicable
Started
View on ClinicalTrials.gov ↗
Trial flagged as At Risk
Primary completion moved at least 2 months later Nov 1, 2026 → Jan 1, 2027
See other at-risk trials from Ankara City Hospital Bilkent

Record History

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  1. Minor Primary completion pushed from Nov 1, 2026 to Jan 1, 2027 Show 4 more changesShow less
    • Study completion pushed from Jan 1, 2027 to Mar 1, 2027
    • Eligibility criteria expanded, about 11 words
    • Secondary endpoints: details revised at 2 of 8 entries
    • Study description expanded, about 2 words
  2. Notable Recruitment openedv2 Show 4 more changesShow less
    • Primary completion pushed from Sep 20, 2026 to Nov 1, 2026
    • Study completion pushed from Oct 20, 2026 to Jan 1, 2027
    • Start date changed from estimate of Mar 20, 2026 to Apr 1, 2026
    • Site details revised
  3. 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  • Stopped: an ongoing trial was terminated, suspended or withdrawn.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.
Elective lumbar fusion surgery is associated with moderate to severe postoperative pain and often requires substantial perioperative opioid administration. Excessive opioid use may lead to adverse effects such as nausea, vomiting, sedation, respiratory depression, and delayed mobilization. Intravenous lidocaine infusion has been proposed as part of multimodal analgesia because of its analgesic, antihyperalgesic, and anti-inflammatory properties. This randomized, placebo-controlled clinical trial aims to evaluate the effect of intraoperative intravenous lidocaine infusion on postoperative opioid consumption and early recovery outcomes in patients undergoing elective lumbar fusion surgery. Patients will be randomly assigned to receive either intravenous lidocaine infusion or placebo during surgery. The primary outcome is cumulative postoperative opioid consumption within the first 24 hours after surgery. Secondary outcomes include intraoperative opioid consumption, postoperative pain scores, time to first rescue analgesic, quality of recovery, postoperative nausea and vomiting, time to mobilization, and length of hospital stay. In addition, inflammatory and oxidative stress biomarkers including interleukin-6 (IL-6) and markers of thiol-disulfide homeostasis will be measured preoperatively and postoperatively.
Trial Details
NCT Number NCT07488832
Lead Sponsor Ankara City Hospital Bilkent
Conditions
(from sponsor)
Lumbar Fusion Surgery
Related terms Postoperative Pain
Enrollment 110 participants
Start Date
Primary Completion (estimated)
Study Completion (estimated)
Updated on ClinicalTrials.gov