Preoperative Nerve Block for Rhinoplasty/Septoplasty

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

UNKNOWN

Clinical Phase

PHASE1/PHASE2

Total Enrollment

70 participants

Study Classification

INTERVENTIONAL

Study Start Date

2019-06-17

Study Completion Date

2022-03-01

Brief Summary

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Addiction is an inherent risk when prescribing opiates for pain relief, and methods to reduce its use or amount prescribed can help mitigate this risk for addiction. Patients undergoing rhinoplasty are often prescribed a short course of opiates during the acute post surgical phase. Studies have shown intraoperative sphenopalatine ganglion (SPG) nerve block in endoscopic sinus surgery can reduce post operative narcotic use. The purpose of this study is to determine if use of SPG block can be used to reduce narcotic use in the acute post operative phase of rhinoplasty/septoplasty.

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Detailed Description

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With the current opioid epidemic, more than 40,000 deaths can be attributed to prescription and illicit opioid use per year. There is inherent risk for patients to develop addiction when prescribing opiates for pain relief, and methods to reduce its use or the amount prescribed can help mitigate this risk.

Surgery is one of the leading causes for prescribing narcotics to control pain. Patients undergoing rhinoplasty are often prescribed a short course of opiates during the acute post surgical phase. Intraoperative sphenopalatine ganglion (SPG) block has been successfully and safely used in endoscopic sinus surgery, and has been shown to decrease narcotic use and inpatient hospital stay time.

The investigators are interested in determining if use of SPG block may offer an improved strategy to reducing the use of narcotics for post rhinoplasty/septoplasty pain relief. The investigators hypothesize that SPG block will reduce the amount of post operative opiates required for pain control.

The study population will include patients undergoing rhinoplasty/septoplasty at Keck Medical Center of USC who are able to provide consent. The study will include two arms: SPG block (experimental) and placebo saline injection (control). Patients' post operative pain scale and narcotic use will be recorded until first follow-up visit (2 weeks). Patient demographics, surgical indication, and intraoperative analgesia will be recorded. T-tests will be conducted between patient groups. ANOVA will be used to analyze other factors that may be associated with decreased narcotic use.

Conditions

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Nasal Fracture Deviated Nasal Septum

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

rhinoplasty/septoplasty patients will be identified by Dr. Kochhar (PI). Patients' informed consent for participation in this study will be obtained and they will subsequently be enrolled. Participants will be randomized into two arms: experimental vs. placebo.

Study arms:

1. Experimental: SPG block with local anesthetic per normal methods of nerve block.
2. Placebo: Injection of saline

Primary Study Purpose

TREATMENT

Blinding Strategy

SINGLE

Participants

After giving consent to participate in study, patients enrolled in study will be randomly assigned to either the experimental vs. normal standard of care. Patients and members of care team will be unaware as to which group they are assigned.

Study Groups

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SPG Block

Sphenopalatine ganglion block

Group Type EXPERIMENTAL

Nerve block

Intervention Type DRUG

0.25% bupivacaine with epinephrine (1:100k), with total volume of 2mL

Placebo Control

Saline injection

Group Type PLACEBO_COMPARATOR

Placebo Saline Injection

Intervention Type DRUG

Saline injection, total volume 2ml

Interventions

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Nerve block

0.25% bupivacaine with epinephrine (1:100k), with total volume of 2mL

Intervention Type DRUG

Placebo Saline Injection

Saline injection, total volume 2ml

Intervention Type DRUG

Eligibility Criteria

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Inclusion Criteria

1. Any patient requiring rhinoplasty/septoplasty and able to provide consent.
2. Must be willing to participate.
3. Must be able to complete consent in English or Spanish.