Investigation of the Effects of Preoperative Ultrasound-Guided Scalp Block on Perioperative Opioid Consumption, Hemodynamic Stability, and Inflammatory Response in Patients Undergoing Craniotomy With a Skull Pin Head Holder
试验速览
- 阶段
- 不适用
- 状态
- 尚未招募
- 发起方
- 入组人数
- 60
- 试验地点
- 1
- 主要终点
- Total opioid consumption within 24 hours postoperatively (morphine milligram equivalents, mg)
研究概览
简要总结
This study shows that in craniotomy patients using a skull pin head holder, an ultrasound-guided scalp block reduces perioperative opioid consumption, improves hemodynamic stability, and decreases the inflammatory response.
详细描述
Craniotomy is a surgical procedure performed to access brain tissue or vascular structures through temporary removal of a portion of the skull (1). The primary goal of neuroanesthesia is to preserve cerebral autoregulation, prevent increases in intracranial pressure, and maintain adequate cerebral perfusion pressure by controlling autonomic nervous system activation induced by surgical stress and nociceptive stimuli (2).
The pin head holder (Mayfield type), which is used to stabilize the surgical field during intracranial procedures, generates intense nociceptive stimulation due to the dense sensory innervation of the scalp. This stimulation may lead to sudden increases in blood pressure and heart rate, thereby raising intracranial pressure (3). Although deep levels of anesthesia and high-dose opioids are commonly used to control this hemodynamic response, such approaches may result in undesirable perioperative outcomes, including respiratory depression, postoperative nausea and vomiting, and prolonged recovery time associated with increased opioid consumption (4,5).
Scalp block is an effective regional anesthesia technique frequently used in intracranial surgery and is based on blocking the sensory nerves of the scalp using local anesthetic agents (3). This technique targets the supraorbital, supratrochlear, zygomaticotemporal, auriculotemporal, greater occipital, and lesser occipital nerves, thereby reducing the transmission of painful stimuli to the central nervous system (6). Scalp block was first described by Pinosky et al. in 1996, and it has been demonstrated that bupivacaine-based scalp block reduces increases in blood pressure and heart rate associated with pin head holder placement and decreases intraoperative anesthetic requirements (3,6).
The use of ultrasonography (USG) in scalp block enhances block accuracy through real-time visualization of superficial nerves and vascular structures, ensures appropriate distribution of local anesthetics within fascial planes, and reduces the risk of complications such as intravascular injection and local anesthetic systemic toxicity (7).
In addition to hemodynamic alterations, surgical trauma and pain also trigger a systemic inflammatory response. During this process, changes in neutrophil, lymphocyte, and platelet counts are reflected in peripheral blood parameters. The neutrophil-to-lymphocyte ratio (NLR), platelet-to-lymphocyte ratio (PLR), systemic inflammatory response index (SIRI), and systemic immune-inflammation index (SII) are used as indicators of surgical stress and inflammation (8,9).
研究设计
- 研究类型
- Observational
- 观察模型
- Cohort
- 时间视角
- Prospective
入排标准
- 年龄范围
- 18 Years 至 —(Adult, Older Adult)
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Aged 18 years and older
- •Scheduled for elective intracranial surgery with skull pin head holder fixation
- •Classified as American Society of Anesthesiologists (ASA) physical status I-III
- •Provided written informed consent in the preoperative period
排除标准
- •Allergy to local anesthetics
- •Coagulopathy or anticoagulant use
- •Local infection at injection site
- •Pregnancy or breastfeeding
- •Chronic opioid use (>3 months) or chronic pain syndrome
- •Severe psychiatric disorders affecting pain assessment
- •Emergency surgery
- •Active infection or rheumatic disease
- •Hematological disease or malignancy (active or within 5 years)
- •Recent use of biological agents, chemotherapy, or corticosteroids (within 30 days)
- •NSAID use within 24 hours before surgery
- •Advanced organ failure (NYHA III-IV, Child-Pugh C, eGFR <30 mL/min)
- •Refusal to participate
- •Communication difficulties preventing pain assessment
研究组 & 干预措施
patient who scalp block applied
Patients who receive an ultrasound-guided preoperative scalp block before skull pin placement and surgical incision
patient without scalp block applied
Patients who do not receive a scalp block and instead undergo local infiltration anesthesia performed by the surgical team before skull pin placement and surgical incision
结局指标
主要结局
Total opioid consumption within 24 hours postoperatively (morphine milligram equivalents, mg)
时间窗: 0-24 hours postoperatively
All opioid analgesics administered within 24 hours postoperatively will be converted to morphine milligram equivalents (mg) for each participant. The outcome will be reported as a single total value per participant.
次要结局
- Mean resting pain score at 24 hours postoperatively measured using the Numeric Rating Scale (0-10)(24 hours postoperatively)
- Mean arterial pressure during pin head holder placement (mmHg)(Perioperative/Periprocedural)
- Mean systemic immune-inflammation index at 24 hours postoperatively(24 hours postoperatively)
- Mean systemic inflammation response index at 24 hours postoperatively(24 hours postoperatively)
- Number of participants requiring rescue analgesia within 24 hours postoperatively(0-24 hours postoperatively)
- Number of participants experiencing postoperative nausea and vomiting within 24 hours(0-24 hours postoperatively)
研究者
Sevgi Duymaz
resident doctor
Fatih Sultan Mehmet Training and Research Hospital
