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NCT03498261
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
Conditions: Pain, Postoperative, Opioid Use
Sex: All
Ages: 18 Years – N/A
Healthy volunteers: Yes
Phase: PHASE1
Enrollment: 50
Sponsor: Ohio State University
Location: The Ohio State University Wexner Medical Center Columbus Ohio
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.
Eligibility 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
Source: ClinicalTrials.gov (NCT03498261). StuddyBuddy aggregates publicly available trial information.