NCT03780478

Preoperative Nerve Block for Rhinoplasty/Septoplasty

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

• Status: Unknown
• Phase: Phase 1 / Phase 2
• Study type: Interventional
• Enrollment: 70 (estimated)
• Sponsor: University of Southern California · Academic / Other
• Sex: All
• Age: 18 Years
• Healthy volunteers: Accepted

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.

Conditions

• Nasal Fracture
• Deviated Nasal Septum

Interventions

Type	Name	Description
DRUG	Nerve block	0.25% bupivacaine with epinephrine (1:100k), with total volume of 2mL
DRUG	Placebo Saline Injection	Saline injection, total volume 2ml

Timeline

• Start date: 2019-06-17
• Primary completion: 2021-12-31
• Completion: 2022-03-01
• First posted: 2018-12-19
• Last updated: 2019-07-30

Locations

1 site across 1 country: United States

Regulatory

• FDA-regulated drug study