Efficacy of Scalp Block on Intraoperative Hemodynamic Responses and Postoperative Analgesia in Patients Undergoing Craniotomy
试验速览
- 阶段
- 不适用
- 状态
- 尚未招募
- 发起方
- 入组人数
- 72
- 主要终点
- Changes in heart rate (beats per minute)
研究概览
简要总结
The goal of this clinical trial is to learn if an ultrasound-guided scalp block can improve intraoperative hemodynamic stability and provide better postoperative pain relief in adult patients undergoing elective supratentorial craniotomy. The main questions it aims to answer are:
Does ultrasound-guided scalp block reduce changes in heart rate and blood pressure during surgery compared with surgical site infiltration?
Does ultrasound-guided scalp block decrease postoperative pain and opioid requirements in the first 24 hours after craniotomy?
Researchers will compare patients receiving an ultrasound-guided scalp block to those receiving standard surgical site infiltration to see if the scalp block provides better perioperative hemodynamic control and postoperative analgesia.
Participants will:
Receive general anesthesia with either ultrasound-guided scalp block or surgical site infiltration
Have heart rate, blood pressure, and other hemodynamic parameters monitored throughout surgery
Receive standard postoperative pain management, with pain scores recorded at 0, 2, 6, 12, and 24 hours
Receive opioids as needed based on pain scores, with total opioid consumption and time to first analgesic dose recorded
Be monitored for adverse events, including nausea, vomiting, sedation, and block-related complications
详细描述
This clinical trial is designed to evaluate whether an ultrasound-guided scalp block improves outcomes in adult patients undergoing elective craniotomy. Craniotomy, a surgical procedure to access the brain, can be associated with significant pain and stress responses during and after surgery. Painful events such as intubation, placement of skull pins, skin incision, and manipulation of the scalp and dura can cause rapid increases in heart rate and blood pressure, which may be harmful, especially in patients with brain injuries or compromised cerebral blood flow.
Currently, these hemodynamic changes are often managed with general anaesthesia and systemic medications such as opioids. However, opioids can delay recovery, cause nausea and vomiting, and interfere with neurological assessments after surgery. Regional anaesthesia techniques, like a scalp block, can reduce the body's stress response to surgery, provide better pain relief, and decrease the need for systemic pain medications. Ultrasound guidance allows anesthesiologists to locate nerves more accurately and perform the block safely, reducing potential complications.
In this study, participants will be randomly assigned to one of two groups. One group will receive a standard surgical site infiltration with local anaesthetic, while the other group will receive an ultrasound-guided scalp block in addition to general anaesthesia. All participants will be closely monitored during surgery, with measurements of heart rate, blood pressure, and other vital signs taken at key points, including before induction, during intubation, at skull pin placement, at skin incision, and at skin closure.
After surgery, participants will receive routine pain management and will be monitored for the first 24 hours. Pain levels will be recorded at multiple time points, and the total use of opioid pain medications, time to first analgesic, and any side effects or complications will be documented.
The main goal of the study is to determine whether the ultrasound-guided scalp block can provide better control of heart rate and blood pressure during surgery and improve postoperative pain relief compared with surgical site infiltration. Secondary goals include assessing the amount of pain medication needed after surgery and the incidence of any side effects, such as nausea, vomiting, or sedation.
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 (Outcomes Assessor)
入排标准
- 年龄范围
- 18 Years 至 64 Years(Adult)
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Age 18-64 years.
- •ASA (American Society of Anesthesiologists) physical status I or II.
- •Patients scheduled for elective supratentorial craniotomy.
- •BMI of 18 to 30 kg/m².
- •GCS score of 9 to 15.
排除标准
- •Patient with instable blood pressure and heart rate.
- •Known allergy or hypersensitivity to local anesthetics.
- •Coagulation disorders or current anticoagulant therapy.
- •Infection at the injection site or systemic infection.
- •Patients with open skull defects.
结局指标
主要结局
Changes in heart rate (beats per minute)
时间窗: 1. Baseline 2. During surgery (Before Induction (T0) After Intubation (T1) After USB/SSI (T2) After the Scull pin insertion (T3) During skin incision (T4) During Dural Opening (T5) During skin closure (T6))
Postoperative pain intensity by Numeric Rating Scale (NRS)
时间窗: Immediately after shifting to the recovery room, 1 hour, 2 hours, 3 hours, 6 hours, 12 hours, 24 hours
Change in Systoloic Blood Pressure (SBP) (in mmHg)
时间窗: 1. Baseline 2. During surgery (Before Induction (T0) After Intubation (T1) After USB/SSI (T2) After the Scull pin insertion (T3) During skin incision (T4) During Dural Opening (T5) During skin closure (T6))
Change in diastolic blood pressure (DBP) (in mmHg)
时间窗: 1. Baseline 2. During surgery (Before Induction (T0) After Intubation (T1) After USB/SSI (T2) After the Scull pin insertion (T3) During skin incision (T4) During Dural Opening (T5) During skin closure (T6))
Change in mean arteial pressure (MAP) (in mmHg)
时间窗: 1. Baseline 2. During surgery (Before Induction (T0) After Intubation (T1) After USB/SSI (T2) After the Scull pin insertion (T3) During skin incision (T4) During Dural Opening (T5) During skin closure (T6))
次要结局
- Total consumption of morphine sulfate(mg) in 24 hours(24 hours)
研究者
Kazi Mahzabin Arin
Assistant Professor
Bangladesh Medical University
