Scalp Block Before Head Pinning or Before Emergence in Supratentorial Tumor Craniotomy: A Randomized Controlled Evaluation of Quality of Recovery and Hemodynamic Responses
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 发起方
- 入组人数
- 60
- 试验地点
- 1
- 主要终点
- Quality of Recovery Score
研究概览
简要总结
This study aims to evaluate the effect of scalp block timing-Group 1 will receive a pre-pinning scalp block, while Group 2 will receive a pre-emergence scalp block.-on postoperative recovery quality in patients undergoing supratentorial tumor craniotomy. The recovery quality will be assessed using the validated Quality of Recovery-40 (QoR-40) questionnaire. A total of 60 patients, aged 18-80 years, classified as ASA I-III and with a Glasgow Coma Scale (GCS) score of 15 upon admission to the recovery unit, will be enrolled. The primary outcome is the QoR-40 score. Secondary outcomes include hemodynamic changes and pain intensity measured by the Visual Analog Scale (VAS).
详细描述
Supratentorial tumor craniotomy is a surgical procedure involving the opening of the skull to access the brain. Awakening patients after craniotomy must be performed gradually to maintain hemodynamic stability. During the procedure, injury to soft tissues and muscles can lead to somatic pain, which may cause hypertension and tachycardia, potentially increasing intracranial pressure and resulting in cerebral edema or hematoma. Therefore, effective postoperative pain management and hemodynamic stability are crucial in neurosurgical patients.
Post-craniotomy pain control methods include opioids, non-steroidal anti-inflammatory drugs (NSAIDs), local anesthetic infiltration at the incision site, and scalp block. However, prolonged opioid use is not recommended due to the risk of dependence and negative cognitive effects. Scalp block has been shown to be effective in controlling post-craniotomy pain and offers prolonged analgesia.
The Quality of Recovery-40 (QoR-40) questionnaire, developed by P.S. Myles, is a validated tool used to assess postoperative recovery. It is a five-point Likert-type scale consisting of 40 items, divided into five subscales: emotional state (9 items), physical comfort (12 items), psychological support (7 items), physical independence (5 items), and pain (7 items). Total scores range from 40 to 200, with higher scores indicating better recovery.
While the efficacy of scalp block in post-craniotomy pain control is well established, limited data exist regarding the influence of timing of block administration on recovery quality. This study aims to compare the effects of preoperative versus postoperative scalp block on recovery, using the QoR-40 questionnaire.
A total of 60 patients undergoing supratentorial tumor craniotomy at Sakarya University Training and Research Hospital will be included. Eligibility criteria include patients aged 18-80 years, classified as ASA I-III, and with a postoperative GCS of 15. Exclusion criteria include chronic preoperative use of analgesics, GCS <15, known allergy to local anesthetics or opioids used in scalp block or patient-controlled analgesia.
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Parallel
- 主要目的
- Supportive Care
- 盲法
- Double (Participant, Outcomes Assessor)
盲法说明
A blinded investigator will monitor intraoperative hemodynamics, evaluate opioid/analgesic use, and assess postoperative recovery using the QoR-40 questionnaire.
入排标准
- 年龄范围
- 18 Years 至 80 Years（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Patients aged between 18 and 80 years.
- •Scheduled for elective supratentorial tumor craniotomy under general anesthesia
- •ASA physical status classification I to III.
- •Glasgow Coma Scale (GCS) score of 15 at the time of emergence from anesthesia.
- •Provide informed consent to participate in the study.
排除标准
- •Chronic use of analgesic medications prior to surgery.
- •Glasgow Coma Scale (GCS) score below 15 postoperatively.
- •Allergy or hypersensitivity to local anesthetics or opioids used in the study.
- •Contraindications for scalp block or patient-controlled analgesia.
- •Patients with severe hepatic, renal, or cardiac dysfunction.
- •Patients unable to comprehend or complete the QoR-40 questionnaire.
研究组 & 干预措施
pre-emergence Group
Patients in this group will receive a scalp block with 0.25% bupivacaine (20 mL) at the end of surgery, before emergence from anesthesia.
干预措施: pre-emergence Group (Procedure)
pre-pinning group
Patients in this group will receive a scalp block with 0.25% bupivacaine (20 mL) after the induction of general anesthesia but prior to head pinning
干预措施: pre-pinning group (Procedure)
结局指标
主要结局
Quality of Recovery Score
时间窗: The observation period extended from the beginning of surgery until 24 hours postoperatively.
Patient recovery will be assessed using the validated Turkish version of the QoR-40 (Quality of Recovery-40) questionnaire, a 40-item Likert-type scale covering five domains: emotional state, physical comfort, psychological support, physical independence, and pain. The total score ranges from 40 (poor recovery) to 200 (excellent recovery).
次要结局
- Perioperative Hemodynamic Changes(Intraoperative (Hemodynamic parameters were monitored from the beginning to the end of surgery.))
- Intraoperative and Postoperative Opioid Consumption(Total opioid consumption will be recorded intraoperatively and within the first 24 hours postoperatively.)
- Postoperative Pain Scores(10 minutes, 2 hours, 6 hours, and 24 hours postoperatively)
研究者
Muhammed Halit Tekeci, MD
Anesthesiology and Reanimation Specialist, M.D.
Sakarya University