Gabapentin for Postoperative Pain After Rhinoplasty

Overseen By Alberto Uribe, MD

Age: 18+

Sex: Any

Trial Phase: Phase 1

Sponsor: Ohio State University

Must not be taking: Opioids, Gabapentin, Pregabalin, Acetaminophen

Disqualifiers: Hepatic disease, Autoimmune, Neurodegenerative, Pregnancy, others

Approved in 3 Jurisdictions This treatment is already approved in other countries

Compensation: Varies

Number of Visits: 3

What You Need to Know Before You Apply

What is the purpose of this trial?

This trial tests whether a single dose of gabapentin before rhinoplasty (nose surgery) can reduce the need for painkillers like opioids after the operation. The main goal is to determine if gabapentin can decrease the amount of pain medication required in the first three days post-surgery. Participants will receive either gabapentin or a placebo (a harmless pill with no active drug) to compare results. Ideal participants are those scheduled for rhinoplasty who have not recently used opioids, gabapentin, or certain other medications and do not have specific health conditions like liver disease or substance abuse issues. As a Phase 1 trial, the research focuses on understanding how the treatment works in people, offering participants a chance to be among the first to receive this treatment.

Do I need to stop taking my current medications for the trial?

The trial requires that you stop taking gabapentin or pregabalin 14 days before surgery and acetaminophen 7 days before surgery. If you are using opioids, you must stop 48 hours before surgery. Other medications are not specified, so check with the trial team.

Is there any evidence suggesting that this trial's treatments are likely to be safe?

Research has shown that gabapentin is generally safe and effective for managing post-surgical pain. It can significantly reduce pain in the first 24 hours after an operation. For instance, some studies found that pain levels dropped by 27% to 39%. Importantly, other research indicates that gabapentin does not increase complications, such as bleeding. This suggests it is safe for surgeries like rhinoplasty (nose surgery). Although this trial is in an early stage, gabapentin's proven safety in other studies and surgeries supports its use. ^{1 2 3 4 5}

Why do researchers think this study treatment might be promising?

Most treatments for postoperative pain after rhinoplasty typically involve opioids, which can be effective but come with risks of addiction and side effects. Gabapentin is unique because it offers a non-opioid alternative for managing pain. Researchers are excited about gabapentin because it targets the central nervous system differently, potentially reducing the need for opioids. This approach not only aims to manage pain effectively but also minimizes the risk of opioid-related complications, making it a promising option for safer postoperative recovery.

What evidence suggests that gabapentin might be an effective treatment for postoperative pain after rhinoplasty?

Research has shown that gabapentin can help manage post-surgical pain and reduce opioid use. In this trial, participants will receive either gabapentin or a placebo to assess its effectiveness in reducing opioid consumption after rhinoplasty. Some studies indicate that patients taking gabapentin report less pain than those who do not. Specifically, gabapentin lowered pain by about 27% to 39% on the first day after surgery. It also effectively relieves pain in the hours immediately following surgery. These findings suggest that gabapentin might help control pain and reduce opioid use after rhinoplasty. ^{1 2 6 7 8}

Who Is on the Research Team?

Leslie Kim, MD

Principal Investigator

Ohio State University

Are You a Good Fit for This Trial?

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.

Inclusion Criteria

I am scheduled for a nose job with general anesthesia.

I can read and have signed the consent form in English.

Exclusion Criteria

Pregnancy or breast feeding

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

I have used gabapentin or pregabalin in the last 14 days.

Timeline for a Trial Participant

Screening

Participants are screened for eligibility to participate in the trial

1 day

1 visit (in-person)

Preoperative

Participants receive a single preoperative dose of gabapentin or placebo before surgery

1 day

1 visit (in-person)

Intraoperative

Standard anesthesia and monitoring procedures are conducted during surgery

Surgery duration

Postoperative

Participants are monitored in PACU and receive pain management; pain levels are recorded

72 hours

Continuous monitoring in PACU

Follow-up

Participants record pain levels and opioid consumption at home; follow-up visit on POD 7

7 days

1 visit (in-person) on POD 7

What Are the Treatments Tested in This Trial?

Interventions

• Gabapentin
• Placebos

Trial Overview 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.

How Is the Trial Designed?

Group I: Gabapentin Active Control 1 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: Placebo Placebo Group 1 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.

Gabapentin is already approved in United States, European Union, Canada for the following indications:

Approved in United States as Neurontin for:

• Postherpetic neuralgia
• Partial-onset seizures

Approved in European Union as Gabapentin for:

• Peripheral neuropathic pain
• Partial-onset seizures

Approved in Canada as Gabapentin for:

• Postherpetic neuralgia
• Partial-onset seizures

Who Is Running the Clinical Trial?

Ohio State University

Lead Sponsor

Trials

891

Recruited

2,659,000+

Citations

1. sciencedirect.com sciencedirect.com/science/article/abs/pii/S0196070923003228

Gabapentin and postoperative pain and opioid consumption Analysis of 35 patients (20 gabapentin, 15 control) showed no significant difference in mean postoperative VAS (p = 0.18) or postoperative opioid consumption ...

2. ejo.springeropen.com ejo.springeropen.com/articles/10.1186/s43163-023-00502-3

The effect of preemptive gabapentin and pregabalin on ... Results showed that the mean pain score in the control group was higher than pregabalin and gabapentin at all times after surgery (P < 0.001).

3. onlinelibrary.wiley.com onlinelibrary.wiley.com/doi/10.1002/lary.32433?af=R

Management of Postoperative Pain in Septorhinoplasty Both studies conclude that neuropathic agents can effectively control postoperative pain and reduce opioid use in septoplasty or rhinoplasty.

4. pmc.ncbi.nlm.nih.gov pmc.ncbi.nlm.nih.gov/articles/PMC2670715/

Use of gabapentin for perioperative pain control – A meta ... Gabapentin caused a significant reduction in postoperative pain at rest (25–28,30–42) in the first 24 h, by 27% to 39% (7.2 mm to 14.3 mm on a scale of 0 mm to ...

5. journals.sagepub.com journals.sagepub.com/doi/abs/10.1177/00034894221089162

A Prospective Randomized Placebo-Controlled Trial Gabapentin, dexamethasone, and gabapentin + dexamethasone are equally more effective analgesics during the first 4 hours postsurgery than placebo.

6. sciencedirect.com sciencedirect.com/science/article/pii/S2950553424000406

Anesthesia for rhinoplasty: A summary of clinical ... Post operative management should ideally consist of acetaminophen and NSAIDs (ibuprofen or celecoxib), leaving opioids only for breakthrough pain. In a prior ...

7. pubmed.ncbi.nlm.nih.gov pubmed.ncbi.nlm.nih.gov/37948826/

Gabapentin and postoperative pain and opioid consumption Preliminary results show no significant change in pain after FESS with or without septoplasty in patients taking 7-day pre- and post-operative gabapentin ...

8. joma.amegroups.org joma.amegroups.org/article/view/6632/html

Acute postoperative pain management for common facial ... Pre-emptive administration of gabapentin has been shown to reduce VAS pain scores within the first 24 hours after a variety of surgeries in the ...