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

2017H0466

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.

2018-01-30

2024-07-30

2024-12-30

Active (not recruiting)

Early phase I

50

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

{'studyType': 'INTERVENTIONAL', 'phases': ['PHASE1'], 'designInfo': {'allocation': 'RANDOMIZED', 'interventionModel': 'SINGLE_GROUP', 'interventionModelDescription': 'Adult patients scheduled to undergo rhinoplasty at the Ohio State University Wexner Medical Center', 'primaryPurpose': 'PREVENTION', 'maskingInfo': {'masking': 'DOUBLE', 'maskingDescription': 'Once the randomization group has been defined, the pharmacist will prepare both medications and will place them inside a bag for further handling. Medications will be identified following institutional standard of procedures.', 'whoMasked': ['PARTICIPANT', 'INVESTIGATOR']}}, 'enrollmentInfo': {'count': 50, 'type': 'ACTUAL'}}

2023-04-26