Preoperative Nerve Block for Rhinoplasty/Septoplasty

Phase 1

• Conditions: Nasal Fracture; Deviated Nasal Septum
• Interventions: Drug: Nerve block; Drug: Placebo Saline Injection

• Registration Number: NCT03780478
• Lead Sponsor: University of Southern California

Brief Summary

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

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.

Basic Information
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Recruitment & Eligibility
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Study & Design
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Trial Locations

Study Timeline

• Study First Submitted: 2018-12-17
• Study First Submitted QC: 2018-12-17
• Study First Posted: 2018-12-19
• Study Start: 2019-06-17
• Status Verified: 2019-07
• Last Update Submitted: 2019-07-28
• Last Update Posted: 2019-07-30
• Primary Completion: 2021-12-31
• Study Completion: 2022-03-01

Recruitment & Eligibility

• Status: UNKNOWN
• Sex: All
• Target Recruitment: 70

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.

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Exclusion Criteria

1. History of opioid substance abuse disorder.
2. <18 years old
3. Currently pregnant

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Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
SPG Block	Nerve block	Sphenopalatine ganglion block
Placebo Control	Placebo Saline Injection	Saline injection

Primary Outcome Measures

Name	Time	Method
Post op Narcotic Use	7 days	Amount of narcotic use in post operative phase will be recorded until follow up visit
Post op Numerical pain scale	7 days	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.

Trial Locations

Locations (1)

Keck Medical Center; 🇺🇸 Los Angeles, California, United States