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A Prospective Randomized Double Blind Trial to Assess the Effect of a Single Preoperative Dose of Gabapentin on Postoperative Opioid Consumption in Patients Undergoing Rhinoplasty

StatusActive, Not Recruiting
PhasePhase 1
Started
View on ClinicalTrials.gov ↗
Trial flagged as At Risk
Primary completion moved at least 2 years later Dec 30, 2025 → Dec 30, 2027
See other at-risk trials from Ohio State University

Record History

See every version on ClinicalTrials.gov ↗

  1. Primary and study completion pushed from Dec 30, 2025 to Dec 30, 2027
    • Eligibility criteria expanded, about 13 words
    • Publications: details revised at 11 of 11 entries
  2. Primary completion date: Jul 30, 2024 to Dec 30, 2025
    • Study completion date: Dec 30, 2024 to Dec 30, 2025
    v6
  3. Primary completion date: Dec 30, 2022 to Jul 30, 2024v5 Show 4 more changesShow less
    • Trial status: Recruiting to Active, Not Recruiting
    • Enrollment target: estimated 64 to confirmed 50
    • Study completion date: Dec 30, 2023 to Dec 30, 2024
    • Site details revised
  4. Trial status: Active, Not Recruiting to Recruiting
    • Primary completion date: Jan 30, 2020 to Dec 30, 2022
    • Study completion date: Feb 7, 2020 to Dec 30, 2023
    • Site details revised
    v4
  5. Re-verified, no change to tracked fieldsv3
  6. Primary endpoint revised
    • Secondary endpoints revised (8)
    v2
  7. 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  • Stopped: an ongoing trial was terminated, suspended or withdrawn.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.
Adding a single preoperative dose of gabapentin to the standard pain regimen will reduce postoperative opioid consumption within the first 72 hours in patients undergoing rhinoplasty.
Trial Details
NCT Number NCT03498261
Lead Sponsor Ohio State University
Conditions
(from sponsor)		 Pain, Postoperative, Opioid Use
Related terms Postoperative Pain
Enrollment 50 participants
Start Date
Primary Completion (estimated)
Study Completion (estimated)
Updated on ClinicalTrials.gov