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

• Status: Recruiting
• Trial end date: 2023-12-30
• Target enrollment: 0
• Participant gender: All

Summary

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.

• Phase: Phase 1
• Accepts Healthy Volunteers?: Accepts Healthy Volunteers

Details

• Lead Sponsor: Ohio State University
• Treatments: Analgesics, Opioid; Gabapentin; gamma-Aminobutyric Acid

Criteria

Inclusion Criteria:

• Patients males and females ≥ 18 years old

• Patients providing a written informed consent in English language

• Patients scheduled to undergo rhinoplasty under general endotracheal anesthesia

Exclusion Criteria:

1. Patients with known allergies to medications described in this study: acetaminophen, gabapentin, and opioids (morphine, fentanyl, hydromorphone, oxycodone)

2. Patients with chronic use of opioids due to any medical/surgical condition or those receiving any opioid medication within the 48 hours before surgery

3. Use of gabapentin and/or pregabalin within the last 14 days prior to surgery

4. Use of acetaminophen within the last 7 days prior to surgery

5. Hepatic disease as documented in patient past medical history

6. Medical history of autoimmune/neurodegenerative disease

7. Pregnancy or breast feeding

8. Patients with history of alcohol or substance abuse/dependency within the last 6 months

9. Patients with previous participation in this study or receiving any investigational product within the last 30 days

10. Patients under legal protection or prisoners