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临床试验/NCT04797559
NCT04797559已完成不适用

Suprazygomatic Maxillary Nerve (SZMN) Blocks for Pain Control in Pediatric Patients Undergoing T&A: Randomized Controlled Trial ]

Stanford University2 个研究点 分布在 1 个国家目标入组 60 人开始时间: 2021年11月29日最近更新:
适应症

试验速览

阶段
不适用
状态
已完成
入组人数
60
试验地点
2
主要终点
Post Surgical Pain

研究概览

简要总结

The suprazygomatic maxillary nerve (SZMN) block is a well-established, safe and effective regional technique for pain management following cleft palate procedures, however, have not been studied for patients undergoing tonsillectomy and adenoidectomy (T&A) procedures. The goals of this study are to determine if SZMN block can be utilized for pain control and decrease morbidity in pediatric patients undergoing T&A.

详细描述

Patients between 6 months and 18 years undergoing T&A surgical procedures will be reviewed for potential study enrollment. If participants agree to participate, they will be randomized into either the suprazygomatic maxillary nerve (SZMN) block treatment cohort or the control cohort i.e standard of care.

After anesthesia induction, patients randomized into the SZMN- treatment group will receive a bilateral single injection SZMN block under general anesthesia in the operating room. The injection will occur near the temples above the cheek bones.

Participants enrolled into the control group will receive standard of care with no changes to their anesthetic or surgical care. Both groups will be asked for their verbal pain scores in the PACU and we will track their opioid consumption throughout the next few days after their procedure.

研究设计

研究类型
Interventional
分配方式
Randomized
干预模型
Single Group
主要目的
Treatment
盲法
Double (Participant, Care Provider)

盲法说明

Both groups will receive a small circular band-aid on their temples.

入排标准

年龄范围
6 Months 至 18 Years(Child, Adult)
性别
All
接受健康志愿者

入选标准

  • Ages 0-18
  • Give consent/parental consent to participate in study
  • Patients undergoing tonsillectomy and adenoidectomy

排除标准

  • Participants who do not consent or have parental consent
  • Patients who are clinically unstable or require urgent/emergent intervention
  • Patients under age 6 months

结局指标

主要结局

Post Surgical Pain

时间窗: 7 days after surgery

Patients will rate their pain on a 0-10 scale

次要结局

  • Opioid Consumption(1-3 hours after surgery (during the patient's stay in post-anesthesia care unit))

研究者

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

Chi-Ho Ban Tsui

Professor

Stanford University

研究点 (2)

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