🏛️ Verified NIH Record • Updated 2025-08-06

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 (NCT03498261)

🔵 Active, Not Recruiting Phase1 💊 Investigational Drug / Biologic Sponsor: Ohio State University

🩺 Plain-English Summary (8th-Grade Level)

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.

Who can join: To join this study, participants generally need to meet the listed inclusion criteria (3 items) and avoid the listed exclusions (11 items).

Location: The Ohio State University Wexner Medical Center — Columbus, Ohio

Age range: 18 Years

🧪 Interventions in This Study

📋 "Do I Qualify?" — 1-Minute Self Screener

Instant Checklist

Check every box below. If you can check all of them, you may meet the study's basic screening requirements (final eligibility is confirmed by the site team).

Usually NOT eligible if any of the following apply:

  • Exclusion Criteria:
  • Patients with known allergies to medications described in this study: acetaminophen, gabapentin, and opioids (morphine, fentanyl, hydromorphone, oxycodone)
  • Patients with chronic use of opioids due to any medical/surgical condition or those receiving any opioid medication within the 48 hours before surgery
  • Use of gabapentin and/or pregabalin within the last 14 days prior to surgery
  • Use of acetaminophen within the last 7 days prior to surgery
  • Hepatic disease as documented in patient past medical history
  • Medical history of autoimmune/neurodegenerative disease
  • Pregnancy or breast feeding
  • Patients with history of alcohol or substance abuse/dependency within the last 6 months
  • Patients with previous participation in this study or receiving any investigational product within the last 30 days
  • Patients under legal protection or prisoners

🔍 Extracted verbatim from the official NIH eligibility criteria. Always confirm with the study coordinator.

📍 All Participating Trial Locations (1 Sites)

  • The Ohio State University Wexner Medical Center — Columbus, Ohio

💰 Cost, Insurance & Patient Rights

  • 100% Free Items: The investigational treatment and protocol-required procedures are supplied at zero cost by the sponsor.
  • Routine Patient Care: Under federal law (ACA § 2709) and many state statutes, routine care costs are covered during participation.
  • Voluntary Participation: You may withdraw at any time without affecting your standard medical care.
  • 💵 Compensation indicated: Once in PACU, patients will receive IV fentanyl as pain rescue medication if required and PACU length of stay will be also recorded.

💡 How to Participate

  1. Check the checklist above to see if you may qualify.
  2. Review the official NIH record below to find the coordinating site.
  3. Ask about the visit schedule, what is covered at no cost, and any travel support.
  4. Confirm with your own doctor before making a decision.
🏛️ View Official NIH Record ↗