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临床试验/NCT05763836
NCT05763836招募中4 期

Comparison of the Analgesic Effects of Scalp Nerve Block and Intravenous Ibuprofen Applications Under the Guidance of Nociception Level Index (NoL) in Patients Undergoing Elective Supratentorial Craniotomy

Ankara University1 个研究点 分布在 1 个国家目标入组 102 人开始时间: 2022年11月1日最近更新:
适应症
干预措施
相关药物

试验速览

阶段
4 期
状态
招募中
入组人数
102
试验地点
1
主要终点
Nociception level (NoL) index

研究概览

简要总结

Introduction: Scalp incision is a powerful nociceptive stimulus that can exacerbate rapid changes in hemodynamic and sympathetic activity. Management of hemodynamic stability is essential in neuro-anesthesia and can be challenging among neurosurgery anesthesiologists. Neurosurgery operations include steps with a lot of painful stimuli such as intubation, insertion of a head-pinning, and craniotomy. A good anesthetic technique can improve hemodynamic responses by reducing the incidence of complications such as intracranial hypertension, bleeding, and longer recovery time. Routine analgesic approach in the intraoperative and postoperative period of supratentorial craniotomy includes the routine use of paracetamol, opioids, scalp nerve block with proven effectiveness, and intravenous ibuprofen, which gives good results by reducing opioid doses in moderate-to-severe pain. Supratentorial craniotomy surgery, which requires tight hemodynamic control, needs effective analgesic methods.

Trial design: It is a prospective, randomized controlled, consisting of factorial groups, double-blind study.

Participants: This study will be carried out at Ankara University Faculty of Medicine İbni Sina Hospital (Altındağ, Ankara, Turkey) between November 2022 and February 2023. One hundred and two ASA I-III patients with a body mass index (BMI) below 30, aged between 18 and 65, who will undergo elective supratentorial craniotomy due to a brain tumor, are planned to be included in the study.

Interventions: The group in which IV ipurofen was administered was named Ibuprofen Group (Group I), the group in which scalp nerve block was applied Block Group (Group), and the group in which IV ibuprofen and scalp nerve block were applied together was named Ibuprofen+Block Group (IB Group). In the premedication unit, 800 mg of ibuprofen in 100 ml of normal saline will be administered to Group I and Group IB, and 100 ml of normal saline without ibuprofen will be administered to Group B as a 30-minute IV infusion. After intubation, a scalp nerve block with 20 ml of 0.5% bupivacaine will be applied to Group B and Group IB, and 20 ml of normal saline will be injected into the block sites in Group I.

Objective: The investigators aimed to show the effect of scalp nerve block and IV ibuprofen applications, which are routinely applied, on the optimization of the patient's process from induction to the early postoperative period. In addition, the investigators will examine the comparison of hemodynamic and analgesic effects of scalp nerve block and IV ibuprofen applications under the guidance of pain monitor, and their contribution to reducing opioid consumption, which has side effects such as postoperative nausea/vomiting, slowing of GI motility, respiratory depression.

Outcome: The primary endpoint of the study was the differences between the groups in the changes in the patients' nociception level (NoL) index, heart rate, and blood pressure parameters at the time of head-pinning and the first surgical skin incision.

Randomization: Randomization of the patients into 3 groups will be carried out using the closed envelope method.

Blinding: The patients included in the study and the practicing anesthesiologist do not know which patient is included in which group.

详细描述

Scalp incision is a powerful nociceptive stimulus that can exacerbate rapid changes in hemodynamic and sympathetic activity. Management of hemodynamic stability is essential in neuro-anesthesia and can be challenging among neurosurgery anesthesiologists. A good anesthetic technique can improve hemodynamic responses by reducing the incidence of complications such as intracranial hypertension, bleeding, and longer recovery time. The stable hemodynamic not only provide an easy-to-perform surgical field, but also prevent serious complications such as bleeding, aneurysm rupture, and cerebral ischemia. In patients with impaired cerebral autoregulation, even a small increase in systemic arterial blood pressure can cause unexpected spikes in cerebral blood flow and intracranial pressure.

Neurosurgery operations include steps with a lot of painful stimuli such as intubation, insertion of a head-pinning, and craniotomy. In these patients where autoregulation may be impaired, it is extremely important to monitor the pain and provide adequate analgesia as well as providing sufficient depth of anesthesia in order to keep the hemodynamics stable.

Craniotomy consists of the steps of such as head-pinning in order to stabilize the head, making a skin incision, cutting the skull bone and removing the dura-mater and reaching the brain parenchyma. This process, which ends with the dura-mater incision, which the investigators define as the early intraoperative period, is the time period in which the most painful stimulus is observed, and accordingly, the increase in the level of vasoactive agents causes an increase in heart rate and blood pressure. In 86% of patients, there is pain of somatic origin, possibly involving soft tissue and pericranial muscles. Pain in this process is generally moderate to severe pain.

It has been reported that the pain after craniotomy is less than the pain after lumbar laminectomy for lumbar disc herniation. However, it has been shown that moderate-to-high pain may occur after craniotomy, especially in the first 2 hours postoperatively, and this is more common than previously thought. Increased oxygen consumption and catecholamine release caused by postoperative pain may predispose to intracranial hematomas by causing brain hyperemia and increased intracranial pressure. Local anesthetic infiltration or systemic analgesics such as non-steroidal anti-inflammatory drugs and opioids are used for craniotomy pain palliation. If the patient is conscious and feels pain after craniotomy, effective analgesia should be provided.

Routine analgesic approach in the intraoperative and postoperative period of supratentorial craniotomy includes the routine use of paracetamol, opioids, scalp nerve block with proven effectiveness, and intravenous (IV) ibuprofen, which gives good results by reducing opioid doses in moderate-to-severe pain. There are studies comparing drugs such as opioids, non-steroidal anti-inflammatory drugs (NSAIDs), ketamine, IV lidocaine, gabapentin in the prevention of the sympathetic response that occurs when entering the spiked cap and in the prevention of post-craniotomy pain and among these, scalp nerve block is accepted as the most effective analgesic approach.

研究设计

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

入排标准

年龄范围
18 Years 至 65 Years(Adult, Older Adult)
性别
All
接受健康志愿者

入选标准

  • Undergoing elective suptatentorial craniotomy surgery
  • Body Mass Index (BMI) below 30
  • ASA I-III patient

排除标准

  • Patients with a history of allergic reaction to the drugs to be used in the study
  • Patients with heart, kidney and liver failure
  • Patients who refused to participate in the study

研究组 & 干预措施

Group Block

Active Comparator

Scalp nerve block applied group

干预措施: Scalp nerve block (Procedure)

Group Ibuprofen

Experimental

Intravenous ibuprofen applied group

干预措施: Ibuprofen 800 Mg in 8 mL INTRAVENOUS INJECTION [Caldolor] (Drug)

Grup Ibuprofen&Block

Experimental

Both intravenous ibuprofen and scalp nerve block applied group

干预措施: Ibuprofen 800 Mg in 8 mL INTRAVENOUS INJECTION [Caldolor] (Drug)

Grup Ibuprofen&Block

Experimental

Both intravenous ibuprofen and scalp nerve block applied group

干预措施: Scalp nerve block (Procedure)

结局指标

主要结局

Nociception level (NoL) index

时间窗: From the beginning of the operation until the 3rd hour after the operation

In this study, the difference between the groups in the change of NoL values due to the procedures applied in supratentorial craniotomy surgery will be evaluated. NoL values range between 0 and 100. Values above 25 indicate that the patient has pain, and the value increases as the pain increases.

次要结局

  • Opioid consumption(After the induction of anesthesia, opioid infusion will be started and continued until the operation is completed and the maintenance of anesthesia is terminated. At the end of the surgery, the total amount of opioid consumed will be recorded.)
  • Heart rate(Heart rate measurements will be recorded during surgery.)
  • Visual Analog Scale(1st, 2nd and 3rd hours after surgery)
  • Dystolic blood pressure(Dystolic blood pressure measurements will be recorded during surgery.)
  • Systolic blood pressure(Systolic blood pressure measurements will be recorded during surgery.)

研究者

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

Ahmet Cem Ceran

Principal Investigator

Ankara University

研究点 (1)

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