ClinicalTrials.gg
Active, not recruitingNCT03498261Updated Sep 25, 2026

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

A Phase 1 interventional study of Gabapentin and Placebos in Pain, Postoperative and Opioid Use, sponsored by Ohio State University. Active, not recruiting at 1 site in United States. Open to participants aged 18 Years and older, including healthy volunteers. Per ClinicalTrials.gov, last updated 2026-09-25.

Sponsored by Ohio State University · Phase 1, Interventional, and Prevention

Updated Sep 25, 2026Primary completion movedStudy completion movedGo to Updates ↓
Phase
Phase 1
Study type
Interventional
Enrollment
50
Allocation
Randomized
Ages
18 Years and older
Sex
All
01

Where this study stands

Counted across the records on this site · 2026-11-12

Among 60 studies testing gabapentin in Pain, Postoperative — 8 open to participants now, 10 under way, 3 of them phase 3. Gabapentin · Pain, Postoperative.

Enrollment
37th of 60
50 · median 66
Started
2018
the only one that year
Phase 1
4 of 60
none open now
Registered
34th of 60
by date

Among the 60 studies testing gabapentin in Pain, Postoperative, this one is the 37th largest by enrollment, is the only one that started in 2018, is one of 4 in phase 1, and was the 34th registered.

By phase

60 studies; the count open now beside each. This study's row is marked.

Phase 425 · 5 open
No phase16 · 1 open
Phase 39 · 0 open
Phase 1this study4 · 0 open
Phase 2/34 · 2 open
Phase 1/21 · 0 open
Phase 21 · 0 open

By the year they started

First in 2005; this study’s year is marked. 1 started in 2018.

Size and results

Median enrollment 66 across the 60 interventional studies. Of the 43 that completed or were terminated, 19 (44%) have results posted.

Watch this landscapeDownload CSVWith an account: a weekly mail of what changed among 60 studies testing gabapentin in Pain, Postoperative, or all of them as a file.
02

Study 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.

Read the detailed description

Study Design A prospective randomized double blind study will be conducted 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 at The Ohio State University Wexner Medical Center.

Preoperative Period After assessing patients' eligibility on the day of the surgery and written informed consent is obtained, subjects will be randomized into two groups: placebo group (group I) and gabapentin group (group II).

Pain level will be assessed and recorded at baseline using the verbal NPRS. A single dose of study medication will be administered within 2 hours before scheduled surgery time. Patients randomized to group I will receive matched oral placebo whereas patients randomized to group II will receive 900 mg of oral gabapentin. Once provided by pharmacy, the study medication will be administered by a blinded nurse in the preoperative area.

Intraoperative Period General anesthesia with desflurane and fentanyl will be provided in all patients. Other anesthetic procedures including intraoperative monitoring, muscle relaxation, endotracheal intubation, mechanical ventilation, fluid management, and the use of intravenous dexamethasone will be carried out in accordance with standard procedures. Ondansetron (4 mg) will be used as PONV prophylaxis in all patients 30 minutes before the end of the surgery. Moreover, an orogastric tube (OGT) will be used for stomach emptying at the end of the surgery and before the emergence of anesthesia.

Postoperative period Closure time will be recorded as T0. The time elapsed from PACU arrival until the first opioid dose (either oral or IV) will be recorded. Once in PACU, patients will receive IV fentanyl as pain rescue medication if required and PACU length of stay will be also recorded. After patients are considered stable based on clinician assessment and willingness to start oral intake, a treatment with oral acetaminophen 650 mg scheduled every 6 hours and oral oxycodone (5-10 mg) as needed (PRN) will be initiated for all patients.

Anesthesiologists and researchers evaluating postoperative outcomes will be blinded. The verbal NPRS will be used to assess postoperative pain level at PACU arrival, and every 30 minutes until hospital discharge. After discharge, pain levels will be recorded by patients in their diary at T6, T12, T24 (6, 12, and 24 hours after T0 respectively), and before requiring breakthrough medication (oxycodone) until postoperative day (POD) 7.

Follow-up phase Patients will be discharged home as per standard of care with oral acetaminophen 650 mg scheduled every 6 hours and a prescription for oral oxycodone 5-10 mg every 4 hours as needed (PRN). At discharge, the patient will be instructed to record his oral opioid consumption (oxycodone) and NPRS scores before each oxycodone dose until POD 7 (see attached diary).

A follow-up visit will be matched with the standard postsurgical visit at POD 7 in order to collect the diary, and count the remaining pills from the oxycodone bottle. Adverse events (AEs) including nausea and vomiting will be assessed and documented during the whole study participation.

03

Conditions studied

  • Pain, Postoperative
  • Opioid Use

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04

Who can participate

Ages eligible
18 Years and older
Sexes eligible
All
Accepts healthy volunteers
Yes

Go through the criteria one by one — yes, no or not sure — and take the list to your doctor or the study team. Kept in this browser only.

Inclusion criteria

  • Patients males and females ≥ 18 years old
  • Patients providing a written in English language
  • Patients scheduled to undergo rhinoplasty under general endotracheal anesthesia

Exclusion criteria

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 /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 product within the last 30 days
  10. Patients under legal protection or prisoners
Terms in these criteria, in plain language(3)

Underlined terms in the criteria open these too. Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.

Informed consent

Before you join, the study team explains what taking part involves — its purpose, what happens, the risks and possible benefits — and answers your questions, so you can decide freely. Consent is usually recorded on a form (the informed consent form, ICF) signed by you or, where the law allows, by someone legally authorised to decide for you.

You can keep asking questions during the study, you are told of new information that matters, and you can choose to leave at any time.

Autoimmune disease

A condition in which the immune system attacks the body’s own tissues, such as rheumatoid arthritis, lupus, psoriasis, type 1 diabetes or inflammatory bowel disease.

Immunotherapy studies often leave out active autoimmune disease, and some name exceptions, such as thyroid disease on replacement hormone. Check the exceptions this study lists.

Investigational drug or device

A drug or device being studied in a clinical trial.

It may be new, or already approved and being studied for another use, dose or form. Criteria often leave out people who took part in another study of one within a recent period, commonly 30 days or five half-lives.

05

Study design

Phase
Phase 1
Primary purpose
Prevention
Allocation
Randomized
Intervention model
Single group
Masking
Double (Participant, Investigator)
Enrollment
50 participants (actual)

Study arms

  • Active comparator
    Gabapentin

    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 comparator
    Placebo

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

    Also known as: Neurotin

  • DrugPlacebos

    Placebo

06

What researchers measure

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.

    Time frame: 72 hours

Secondary outcomes

  1. Pain Assessment

    To assess postoperative pain based on verbal Numeric Pain Rating Scale (NPRS), zero being no pain and ten being the worst possible pain, in the post-anesthesia care unit (PACU) and upon discharge.

    Time frame: 7 days

  2. IV Opioids in PACU

    To compare intravenous opioid consumption during PACU stay

    Time frame: 7 days

  3. Time to rescue medication

    To determine the time elapsed from PACU arrival until the first dose of postoperative pain rescue medication requested by the patient

    Time frame: 7 days

  4. Opioids within 7 days

    To compare opioid consumption and NPRS within the first 7 days after the surgery

    Time frame: 7 days

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

    To assess the post-anesthesia care unit length of stay (minutes) from end of the surgery until the end of recovery phase II

    Time frame: 7 days

  6. Nausea

    To compare the incidence of postoperative nausea and vomiting during PACU stay

    Time frame: 7 days

  7. Side Effects

    To assess the incidence of gabapentin-related side effects

    Time frame: 7 days

  8. Respiratory Distress

    To assess the incidence of respiratory distress during post-anesthesia care unit stay, defined as oxygen saturation ≤ 92%

    Time frame: 7 days

07

Study locations

1 site
08

References and documents

Publications

  • 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. PubMed 28145848 ↗
  • 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. PubMed 24057811 ↗
  • 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. PubMed 26395094 ↗
  • 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. PubMed 22130915 ↗
  • 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. PubMed 23945010 ↗
  • 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. PubMed 29507965 ↗
  • 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. PubMed 27459955 ↗
  • 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. PubMed 15271709 ↗
  • 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. PubMed 20012076 ↗
  • 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. PubMed 28901981 ↗
  • 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. PubMed 23681498 ↗

Individual participant data

Plan to share: No

09

Updates

1 registry update since Sep 25, 2026
Primary completion
Dec 30, 2025→Dec 30, 2027
Sep 25, 2026
Study completion
Dec 30, 2025→Dec 30, 2027
Sep 25, 2026
Show all 1 update
  1. Sep 25, 2026
    Primary completion Dec 30, 2025→Dec 30, 2027
    Study completion Dec 30, 2025→Dec 30, 2027
    + 1 other change: verification date

From the registry record's own update history. This site started tracking changes on Sep 25, 2026; for anything earlier, see the record history on ClinicalTrials.gov ↗

10

Registry details

Key details

Study ID
NCT03498261
Responsible party
Leslie Kim (Assistant Professor - Clinical, Ohio State University) — Principal investigator
First posted
Apr 13, 2018
Start date
Jan 30, 2018
Primary completion
Dec 30, 2027 (estimated)
Completion
Dec 30, 2027 (estimated)
Last update
Sep 25, 2026

Study contacts

Leslie Kim, MD
principal investigator · Ohio State University

Oversight

Data monitoring committee
No
FDA-regulated drug
Yes
FDA-regulated device
No
View the source record on ClinicalTrials.gov ↗

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Studies of the drug tested here: Gabapentin

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