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 Phase 1 FDA Drug

• 1 other identifier: 2017H0466
• Study Type: interventional
• Target: 50
• Locations: 1 country
• Sites: 1

Brief 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.

Conditions

Pain, Postoperative; Opioid Use

Outcome Measures

Primary Outcomes (1)

• Effects of Gabapentin vs Placebo in Postoperative Opioid Consumption

  To assess the effect of a single preoperative dose of gabapentin on postoperative opioid consumption within the first 72 hours when compared to oral placebo in patients undergoing rhinoplasty.

  72 hours

Secondary Outcomes (8)

• Pain Assessment

  7 days

• IV Opioids in PACU

  7 days

• Time to rescue medication

  7 days

• Opioids within 7 days

  7 days

• Length of stay (minutes) in recovery from end of surgery until discharge.

  7 days

Study Arms (2)

Gabapentin

ACTIVE COMPARATOR

The primary outcome of interest will be used to evaluate the efficacy of a single preoperative dose of gabapentin when compared to placebo on opioid consumption in patients undergoing rhinoplasty.

Drug: Gabapentin

Placebo

PLACEBO COMPARATOR

The primary outcome of interest will be used to evaluate the efficacy of a single preoperative dose of gabapentin when compared to placebo on opioid consumption in patients undergoing rhinoplasty.

Drug: Placebos

Interventions

Gabapentin DRUG

Gabapentin has been commonly used as an adjuvant in the treatment of neuropathic pain.

Also known as: Neurotin

Gabapentin

Placebos DRUG

Placebo

Placebo

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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

You may not qualify if:

• 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

Sponsors & Collaborators

• Ohio State University: lead

Study Sites (1)

The Ohio State University Wexner Medical Center

Columbus, Ohio, 43210, United States

Location

Related Publications (11)

• Ishii LE, Tollefson TT, Basura GJ, Rosenfeld RM, Abramson PJ, Chaiet SR, Davis KS, Doghramji K, Farrior EH, Finestone SA, Ishman SL, Murphy RX Jr, Park JG, Setzen M, Strike DJ, Walsh SA, Warner JP, Nnacheta LC. Clinical Practice Guideline: Improving Nasal Form and Function after Rhinoplasty Executive Summary. Otolaryngol Head Neck Surg. 2017 Feb;156(2):205-219. doi: 10.1177/0194599816683156.

  PMID: 28145848 BACKGROUND

• Demirhan A, Tekelioglu UY, Akkaya A, Bilgi M, Apuhan T, Karabekmez FE, Bayir H, Kurt AD, Kocoglu H. Effect of pregabalin and dexamethasone addition to multimodal analgesia on postoperative analgesia following rhinoplasty surgery. Aesthetic Plast Surg. 2013 Dec;37(6):1100-6. doi: 10.1007/s00266-013-0207-0. Epub 2013 Sep 21.

  PMID: 24057811 BACKGROUND

• Sari E, Simsek G. Comparison of the Effects of Total Nasal Block and Central Facial Block on Acute Postoperative Pain, Edema, and Ecchymosis After Septorhinoplasty. Aesthetic Plast Surg. 2015 Dec;39(6):877-80. doi: 10.1007/s00266-015-0565-x. Epub 2015 Sep 22.

  PMID: 26395094 BACKGROUND

• Wittekindt D, Wittekindt C, Schneider G, Meissner W, Guntinas-Lichius O. Postoperative pain assessment after septorhinoplasty. Eur Arch Otorhinolaryngol. 2012 Jun;269(6):1613-21. doi: 10.1007/s00405-011-1854-x. Epub 2011 Dec 1.

  PMID: 22130915 BACKGROUND

• Argoff CE. Recent management advances in acute postoperative pain. Pain Pract. 2014 Jun;14(5):477-87. doi: 10.1111/papr.12108. Epub 2013 Aug 15.

  PMID: 23945010 BACKGROUND

• Han B, Compton WM, Blanco C, Jones CM. Prescription Opioid Use, Misuse, and Use Disorders in U.S. Adults. Ann Intern Med. 2018 Mar 6;168(5):383-384. doi: 10.7326/L17-0700. No abstract available.

  PMID: 29507965 BACKGROUND

• Sanders JG, Dawes PJ. Gabapentin for Perioperative Analgesia in Otorhinolaryngology-Head and Neck Surgery: Systematic Review. Otolaryngol Head Neck Surg. 2016 Dec;155(6):893-903. doi: 10.1177/0194599816659042. Epub 2016 Jul 26.

  PMID: 27459955 BACKGROUND

• Turan A, Memis D, Karamanlioglu B, Yagiz R, Pamukcu Z, Yavuz E. The analgesic effects of gabapentin in monitored anesthesia care for ear-nose-throat surgery. Anesth Analg. 2004 Aug;99(2):375-8, table of contents. doi: 10.1213/01.ANE.0000136646.11737.7B.

  PMID: 15271709 BACKGROUND

• Kazak Z, Meltem Mortimer N, Sekerci S. Single dose of preoperative analgesia with gabapentin (600 mg) is safe and effective in monitored anesthesia care for nasal surgery. Eur Arch Otorhinolaryngol. 2010 May;267(5):731-6. doi: 10.1007/s00405-009-1175-5. Epub 2009 Dec 10.

  PMID: 20012076 BACKGROUND

• Helander EM, Billeaud CB, Kline RJ, Emelife PI, Harmon CM, Prabhakar A, Urman RD, Kaye AD. Multimodal Approaches to Analgesia in Enhanced Recovery After Surgery Pathways. Int Anesthesiol Clin. 2017 Fall;55(4):51-69. doi: 10.1097/AIA.0000000000000165. No abstract available.

  PMID: 28901981 BACKGROUND

• Mathiesen O, Dahl B, Thomsen BA, Kitter B, Sonne N, Dahl JB, Kehlet H. A comprehensive multimodal pain treatment reduces opioid consumption after multilevel spine surgery. Eur Spine J. 2013 Sep;22(9):2089-96. doi: 10.1007/s00586-013-2826-1. Epub 2013 May 17.

  PMID: 23681498 BACKGROUND

MeSH Terms

Conditions

Pain, Postoperative

Interventions

Gabapentin

Condition Hierarchy (Ancestors)

Postoperative Complications; Pathologic Processes; Pathological Conditions, Signs and Symptoms; Pain; Neurologic Manifestations; Signs and Symptoms

Intervention Hierarchy (Ancestors)

Amines; Organic Chemicals; gamma-Aminobutyric Acid; Aminobutyrates; Butyrates; Acids, Acyclic; Carboxylic Acids; Cyclohexanecarboxylic Acids; Acids, Carbocyclic; Cyclohexanes; Cycloparaffins; Hydrocarbons, Alicyclic; Hydrocarbons, Cyclic; Hydrocarbons; Amino Acids; Amino Acids, Peptides, and Proteins

Study Officials

• Leslie Kim, MD

  Ohio State University

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: phase 1
• Allocation: RANDOMIZED
• Masking: DOUBLE
• Who Masked: PARTICIPANT, INVESTIGATOR
• Masking Details: 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.
• Purpose: PREVENTION
• Intervention Model: SINGLE GROUP
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Assistant Professor - Clinical

Model Details: Adult patients scheduled to undergo rhinoplasty at the Ohio State University Wexner Medical Center

Study Record Dates

• First Submitted: April 6, 2018
• First Posted: April 13, 2018
• Study Start: January 30, 2018
• Primary Completion: December 30, 2025
• Study Completion: December 30, 2025
• Last Updated: August 11, 2025

Record last verified: 2025-08

Data Sharing

• IPD Sharing: Will not share

Locations

US (1)