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Gabapentin for Postoperative Pain After Rhinoplasty

Phase 1
Waitlist Available
Led By Leslie Kim, MD
Research Sponsored by Ohio State University
Eligibility Criteria Checklist
Specific guidelines that determine who can or cannot participate in a clinical trial
Must have
Patients scheduled to undergo rhinoplasty under general endotracheal anesthesia
Patients providing a written informed consent in English language
Timeline
Screening 3 weeks
Treatment Varies
Follow Up 72 hours
Awards & highlights

Study Summary

This trial found that adding gabapentin to the standard pain regimen for people undergoing rhinoplasty reduced postoperative opioid consumption within the first 72 hours.

Who is the study for?
This trial is for adults over 18 who are having a nose job (rhinoplasty) and can consent in English. It's not for pregnant or breastfeeding people, those with recent drug abuse, allergies to study drugs, liver disease, autoimmune conditions, or anyone on certain pain meds recently.Check my eligibility
What is being tested?
The study tests if taking Gabapentin before surgery reduces the need for opioids after a nose job. Participants will either get Gabapentin or a placebo without knowing which one. The focus is on opioid use within the first three days post-surgery.See study design
What are the potential side effects?
Gabapentin may cause dizziness, sleepiness, swelling in limbs, and difficulty walking. Opioids can lead to nausea, constipation, addiction risk and respiratory depression if taken in high doses.

Eligibility Criteria

Inclusion Criteria

You may be eligible if you check “Yes” for the criteria below
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I am scheduled for a nose job with general anesthesia.
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I can read and have signed the consent form in English.
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I am 18 years old or older.

Timeline

Screening ~ 3 weeks
Treatment ~ Varies
Follow Up ~72 hours
This trial's timeline: 3 weeks for screening, Varies for treatment, and 72 hours for reporting.

Treatment Details

Study Objectives

Outcome measures can provide a clearer picture of what you can expect from a treatment.
Primary outcome measures
Gabapentin
Secondary outcome measures
IV Opioids in PACU
Length of stay (minutes) in recovery from end of surgery until discharge.
Nausea
+5 more

Trial Design

2Treatment groups
Active Control
Placebo Group
Group I: GabapentinActive Control1 Intervention
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.
Group II: PlaceboPlacebo Group1 Intervention
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.

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Logistics

Participation is compensated

You will be compensated for participating in this trial.

Who is running the clinical trial?

Ohio State UniversityLead Sponsor
819 Previous Clinical Trials
472,837 Total Patients Enrolled
2 Trials studying Postoperative Pain
162 Patients Enrolled for Postoperative Pain
Leslie Kim, MDPrincipal InvestigatorOhio State University

Media Library

Gabapentin (Other) Clinical Trial Eligibility Overview. Trial Name: NCT03498261 — Phase 1
Postoperative Pain Research Study Groups: Gabapentin, Placebo
Postoperative Pain Clinical Trial 2023: Gabapentin Highlights & Side Effects. Trial Name: NCT03498261 — Phase 1
Gabapentin (Other) 2023 Treatment Timeline for Medical Study. Trial Name: NCT03498261 — Phase 1

Frequently Asked Questions

These questions and answers are submitted by anonymous patients, and have not been verified by our internal team.

Has Gabapentin obtained the necessary authorization from the FDA?

"Due to the Phase 1 nature of this clinical trial, our internal assessment of Gabapentin's safety is rated at a 1. This rating takes into account limited data surrounding both efficacy and safety."

Answered by AI

Are there still openings available for individuals to join this clinical experiment?

"Clinicaltrials.gov reflects that this medical trial is still searching for participants, having first been posted on January 30th 2018 and last updated on September 23rd 2021."

Answered by AI

What conditions are ameliorated by prescribed Gabapentin?

"Gabapentin is an efficacious remedy for managing neuralgia, epilepsies, and postherpetic neuralgia."

Answered by AI

Are there any historical precedents of Gabapentin being used in a research setting?

"At the moment, 25 medical trials are currently underway for Gabapentin with 9 studies in their final testing phase. The bulk of these tests take place in Columbus, Ohio; however, 67 other locations across America are also running trials on this medication."

Answered by AI

How many people have joined the experiment thus far?

"Affirmative. According to information present on clinicaltrials.gov, this research project is presently accepting subjects into the study. It was initially posted on 30th January 2018 and last revised on 23rd September 2021; 64 individuals are required from a single medical facility for enrolment in this trial."

Answered by AI
Recent research and studies
~3 spots leftby Jul 2024