跳至主要内容
临床试验/NCT07131046
NCT07131046已完成不适用

A Comparative Analysis of Combined Superficial Cervical Plexus and Supraorbital Blocks Compared to Scalp Blocks During Craniotomy: a Review of Opioid Consumption and The Suppression of Hemodynamic Responses

Indonesia University1 个研究点 分布在 1 个国家目标入组 41 人开始时间: 2025年2月18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
41
试验地点
1
主要终点
Remifentanil consumption for each step of surgery

研究概览

简要总结

Perioperative pain management in craniotomy requires the administration of effective regional anesthetic techniques to reduce the use of systemic opioids and optimize hemodynamic control. Scalp block has been demonstrated to suppress hemodynamic response; however, its implementation generally involves a large number of injection points (six nerves that must be blocked bilaterally, resulting in a total of 12 injection points) and the possibility that not all nerve points are adequately blocked. Meanwhile, superficial cervical plexus and supraorbital block involves fewer injection points (two nerves to be blocked bilaterally, for a total of four injection points) with an analgesia area that may be sufficient to facilitate craniotomy surgery, including the insertion of Mayfield pins, consisting of only three pins, where the pin insertion area is not too large. The objective of this study is to compare the efficacy of combined superficial cervical plexus and supraorbital block with scalp block in reducing intraoperative opioid consumption and controlling hemodynamic response in craniotomy surgery.

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)

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
否

入选标准

  • •The patient has been scheduled to undergo a craniotomy procedure that has been deemed medically necessary and electively scheduled. The aforementioned procedure will be performed under the administration of general anesthesia and the utilization of Mayfield pins.
  • •Adult patients who have reached an age of 18 years and have not yet reached 65 years of age are included in this study.
  • •Patients with ASA classification 1 - 3
  • •The patient has expressed their willingness to participate in a research study and has provided their signature on an informed consent form.

排除标准

  • •The patient has been diagnosed with an infection in the area where the block needle insertion is to be performed.
  • •The subjects of this study were patients with a body mass index (BMI) greater than 30 kg/m2 who were classified as Grade II obese.
  • •The patient is currently undergoing treatment with a beta-blocker.
  • •Patients in whom intraoperative evoked potential monitoring is scheduled.
  • •The patient is scheduled to undergo a total intravenous anesthesia technique
  • •The history of an allergy to local anesthesia is presented before.

研究组 & 干预措施

Combination of superficial cervical plexus block and supraorbital block

Experimental

干预措施: Combination of superficial cervical plexus block and supraorbital block (Procedure)

Scalp block

Sham Comparator

干预措施: Scalp block with bupivacaine alone (Procedure)

结局指标

主要结局

Remifentanil consumption for each step of surgery

时间窗: intraoperative

The target effect of the highest dose of Remifentanil administered by total controlled infusion when there is an increase in MAP or heart rate by more than 20% of the initial value for 30 seconds during Mayfield pin placement, skin incision, periosteal manipulation, and skin suturing.

The total amount of Remifentanil administered during the operation

时间窗: Intraoperative

The total amount of remifentanil that the medical team used during the surgery

The greatest alterations in mean arterial pressure (MAP) during the pinning procedure, followed by skin incision, periosteum manipulation, and skin suture.

时间窗: Intraoperative

Changes in mean arterial pressure were measured at several points: 30 minutes after the block was administered; during pin insertion; during skin incision; during periosteal incision; and during skin suturing.

The greatest alteration in heart rate during the pinning procedure, followed by skin incision, periosteum manipulation, and skin suture.

时间窗: Intraoperative

Changes in heart rate were measured at several points: 30 minutes after the block was administered; during pin insertion; during skin incision; during periosteal incision; and during skin suturing.

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

Pryambodho Pryambodho

Anesthesiologist, Principal Investigator

Indonesia University

研究点 (1)

Loading locations...

相似试验