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临床试验/NCT05854537
NCT05854537已完成不适用

Sphenopalatine Ganglion Block in Patients Undergoing Maxillofacial Surgeries: A Randomized Double-blinded Study

Ain Shams University2 个研究点 分布在 1 个国家目标入组 60 人开始时间: 2023年8月20日最近更新:
适应症
干预措施

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
Postoperative pain

研究概览

简要总结

Patients will be divided into 2 groups, 30 each. Group A will receive sphenopalatine ganglion block via a gauze soaked in local anesthetic introduced in the 2 nostrils then by local anesthetic injected by a cannula into both nostrils. Group B will undergo the same procedure, but normal saline will be used instead of the local anesthetic.

详细描述

The local anesthetic mixture will be prepared using a 1:1 combination of xylocaine 2% and bupivacaine 0.5% in a 10 mL syringe. On admission to the operating room (OR) blood pressure, heart rate, and oxygen saturation at room air will be recorded.

The patient will then lie supine with slight neck extension, with nostrils pointing upwards.

Group A patients will have the cotton swab soaked in the local anesthetic (LA) medication introduced into their nostrils along the superior edge of the middle concha to the posterior wall of the nasopharynx to receive approximately 0.5ml of the medication. Then the investigators will inject 1.5 ml of medication via a syringe connected to a 20 gauge (G) catheter into their nostrils bilaterally.

Group B patients will undergo the same procedure but the cotton swab will be soaked into a normal saline solution, and the injection will also be done with normal saline.

After 5 minutes a standard anesthetic technique will be followed. After preoxygenation for three minutes, anesthesia will be induced with propofol 2 mg/kg, fentanyl 2 µg/kg, and atracurium besylate 0.5 mg/kg will provide muscle relaxation. The patient will be monitored using the 4 standard general anesthesia monitors; pulse oximeter, capnogram, non-invasive blood pressure (NIBP), and the 5 lead ECG for the whole operation, in addition to the bi spectral index (BIS) till the end of the surgery, extubation, and transfer to the post-anesthesia care unit (PACU).

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
Double (Participant, Investigator)

入排标准

年龄范围
18 Years 至 60 Years(Adult)
性别
All
接受健康志愿者

入选标准

  • Patients between 18 and 60 years undergoing maxillofacial surgeries

排除标准

  • Patient refusal
  • Patients with fracture nose
  • Operation time of more than 4 hours

研究组 & 干预措施

Sphenopalatine ganglion block using bupivacaine: xylocaine mixture for maxillofacial surgeries

Active Comparator

Patients will have the cotton swab soaked in the LA medication (bupivacaine: lidocaine) introduced into their nostrils along the superior edge of the middle concha to the posterior wall of the nasopharynx to receive approximately 0.5ml of the medication. Then they will have 1.5 ml of the medication injected via a syringe connected to a 20 G catheter into their nostrils bilaterally.

干预措施: Sphenopalatine ganglion block using bupivacaine: xylocaine (Procedure)

Sphenopalatine ganglion block using normal saline for maxillofacial surgeries

Placebo Comparator

Patients will undergo the same procedure but the cotton swab will be soaked into a normal saline solution, and the injection will be done by normal saline as well.

干预措施: Sphenopalatine ganglion block using normal saline (Procedure)

结局指标

主要结局

Postoperative pain

时间窗: 6 hours postoperative

Postoperative pain will be assessed by the Visual Analog Score (VAS) after 6 hours, the (VAS) is a scale from 1 to 10 where 1 is the least pain and 10 is the worst pain

次要结局

  • Intraoperative opioid consumption(4 hours)
  • Blood loss(4 hours)

研究者

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

Sameh Refaat

Lecturer of anesthesia

Ain Shams University

研究点 (2)

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