Preoperative Nerve Block for Rhinoplasty/Septoplasty

Study Overview
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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.

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.

Official Title
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Evaluation of a Preoperative Nerve Block in Pain Scores Following Rhinoplasty/Septoplasty

Conditions
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Nasal Fracture, Deviated Nasal Septum

Intervention / Treatment
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* Drug: Nerve block
* Drug: Placebo Saline Injection


Participation Criteria
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Eligibility Criteria
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Inclusion Criteria: Any patient requiring rhinoplasty/septoplasty and able to provide consent. Must be willing to participate. Must be able to complete consent in English or Spanish. Exclusion Criteria: History of opioid substance abuse disorder. <18 years old Currently pregnant

Ages Eligible for Study
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Minimum Age: 18 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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Accepts Healthy Volunteers

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Treatment
Allocation: Randomized
Intervention Model: Parallel Assignment
Interventional Model Description: 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: Experimental: SPG block with local anesthetic per normal methods of nerve block. Placebo: Injection of saline
Masking: Single


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: SPG Block<br>Sphenopalatine ganglion block | Drug: Nerve block<br>* 0.25% bupivacaine with epinephrine (1:100k), with total volume of 2mL<br>|
| Placebo Comparator: Placebo Control<br>Saline injection | Drug: Placebo Saline Injection<br>* Saline injection, total volume 2ml<br>|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Post op Narcotic Use | Amount of narcotic use in post operative phase will be recorded until follow up visit | 7 days | 
| Post op Numerical pain scale | Pain scale will be recorded daily until follow up visit. Pain scale is defined as 0-10, where 0 is no pain, and 10 is worst pain ever experienced. Pain score will be obtained daily, and experimental arm will be compared with control arm. | 7 days |