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临床试验/NCT03780478
NCT03780478Unknown1 期

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

University of Southern California1 个研究点 分布在 1 个国家目标入组 70 人开始时间: 2019年6月17日最近更新:
适应症
干预措施
相关药物

试验速览

阶段
1 期
入组人数
70
试验地点
1
主要终点
Post op Narcotic Use

研究概览

简要总结

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.

详细描述

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.

研究设计

研究类型
Interventional
分配方式
Randomized
干预模型
Parallel
主要目的
Treatment
盲法
Single (Participant)

盲法说明

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.

入排标准

年龄范围
18 Years 至 —(Adult, Older Adult)
性别
All
接受健康志愿者

入选标准

  • 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.

排除标准

  • History of opioid substance abuse disorder.
  • <18 years old
  • Currently pregnant

研究组 & 干预措施

SPG Block

Experimental

Sphenopalatine ganglion block

干预措施: Nerve block (Drug)

Placebo Control

Placebo Comparator

Saline injection

干预措施: Placebo Saline Injection (Drug)

结局指标

主要结局

Post op Narcotic Use

时间窗: 7 days

Amount of narcotic use in post operative phase will be recorded until follow up visit

Post op Numerical pain scale

时间窗: 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.

次要结局

未报告次要终点

研究者

申办方类型
Other
责任方
Principal Investigator
主要研究者

Amit Kochhar

Clinical Assistant Professor of Otolaryngology -Head & Neck Surgery

University of Southern California

研究点 (1)

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