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临床试验/NCT06264765
NCT06264765Unknown不适用

Comparison Of The Effect Of Scalp Block And Incision Sıte Infiltratıon Applied On Postoperative Acute Paın And Hemodynamics In Patients Undergoing Craniotomy

Aydin Adnan Menderes University2 个研究点 分布在 2 个国家目标入组 62 人开始时间: 2024年1月1日最近更新:
适应症

试验速览

阶段
不适用
发起方
入组人数
62
试验地点
2
主要终点
opioid consumption

研究概览

简要总结

Postoperative pain after craniotomy is an important clinical problem as it can lead to hypertension and increased intracranial pressure. Multimodal analgesia methods are performed by anesthesiologists in different ways depending on the anesthetist's preference.

In addition, both techniques have been shown in studies to provide intraoperative hemodynamic stabilization in addition to their effects on postoperative pain. Although there are many studies on both techniques, the number of studies comparing scalp block with infiltration technique is very limited. Therefore, postoperative use of scalp block and incisional infiltration for postoperative pain after craniotomy is recommended.

详细描述

intraoperative Routine anesthesia induction will be applied after routine monitoring in the operating room. Anesthesia will be induced with propofol (1.5-2 mg/kg), rocuronium (0.6 mg/kg), fentanyl (1mcg/kg), 0.7 FiO2 oxygen. After intubation, general anesthesia will be maintained with the effect site model of target control infusion with propofol and remifentanil. Target concentrations will be maintained at 2 to 3 µg/ml propofol and 2 to 6 ng/ml remifentanil. The propofol dose was titrated according to the depth of anesthesia. The bispectral index will be kept between 45 and 60. Radial artery and urinary catheter will be inserted.

Group S: Following induction of anesthesia, a scalp block will be performed before the surgery begins.

Group I: Incisional infiltration will be performed before the surgery begins, following induction of anesthesia for the patient.

Scalp block: Scalp block will be performed by the anesthesiologist 10 minutes before the pin head holder application (PHHA). Supraorbital and supratrochlear nerves will be blocked bilaterally with 6 ml of 0.5% bupivacaine injected vertically into the skin above the eyebrow midline. Auriculotemporal nerves will be blocked bilaterally by injecting 4 ml of 0.5% bupivacaine 1.5 cm anterior to the ear at the tragus level. The needle will be inserted perpendicular to the skin and the fascia will be injected deeply and superficially while the needle is withdrawn. Postauricular branches of the greater auricular nerves will be blocked bilaterally with 2 ml of 0.5% bupivacaine injected 1 cm posterior to the ear, between the bone and skin, at the level of the tragus. The greater, lesser, and third occipital nerves will be blocked bilaterally with 8 ml of 0.5% bupivacaine injected along the upper nuchal line, approximately halfway between the occipital protuberance and the mastoid prominence.

Incisional infiltration: 20 ml of 0.5% bupivacaine will be infiltrated by the surgeon into the PHHA points and surgical incision areas 10 minutes before PHHA. If the mean arterial pressure (MAP) and heart rate increase above 20% of the baseline values in both groups, additional remifentanil 50 µg IV will be administered.

研究设计

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

盲法说明

Blind patients and postoperative follow-ups will not know which group the patient is in the study.

入排标准

年龄范围
18 Years 至 75 Years(Adult, Older Adult)
性别
All
接受健康志愿者

入选标准

  • Patients who underwent craniotomy under elective conditions
  • 18-75 years old

排除标准

  • Emergency surgery
  • Presence of contraindications to the LA agents used in this study
  • Chronic use of opioids
  • Psychiatric disorders
  • Presence of infection at the injection site
  • Uncontrolled intracranial hypertension
  • Chronic hypertension,
  • Coronary artery disease, arrhythmia,
  • Coagulopathy,
  • Patients who have previously undergone craniotomy

结局指标

主要结局

opioid consumption

时间窗: 24 hours

Postoperative 30th minute, 1st, 6th, 12th, 18th. Patients' opioid consumption on the PCA will be recorded at the 24th and 24th hours.

次要结局

  • The Numeric Rating Scale (NRS)(24 hours)

研究者

发起方
Aydin Adnan Menderes University
申办方类型
Other
责任方
Principal Investigator
主要研究者

ferdi gülaştı

ANESTHESİOLOGİST

Aydin Adnan Menderes University

研究点 (2)

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