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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

Be older than 18 years old

Must not have

Patients with chronic use of opioids due to any medical/surgical condition or those receiving any opioid medication within the 48 hours before surgery

Hepatic disease as documented in patient past medical history

Timeline

Screening 3 weeks

Treatment Varies

Follow Up 72 hours

Awards & highlights

All Individual Drugs Already Approved

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.

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.

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.

Exclusion Criteria

You may be eligible for the trial if you check “No” for criteria below:

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I regularly use opioids for a medical condition or have taken them within 48 hours before surgery.

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I have a history of liver disease.

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I am not allergic to acetaminophen, gabapentin, or opioids.

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I have a history of autoimmune or neurodegenerative disease.

Timeline

Screening ~ 3 weeks3 visits

Treatment ~ Varies

Follow Up ~ 72 hours

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

Study objectives can provide a clearer picture of what you can expect from a treatment.

Primary study objectives

Gabapentin

Secondary study objectives

IV Opioids in PACU

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

Nausea

+5 more

Awards & Highlights

All Individual Drugs Already Approved

Therapies where all constituent drugs have already been approved are likely to have better-understood side effect profiles.

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.

0 / 5Eligibility criteria met