Enhanced Recovery After Surgery Approach May Mitigate Post-craniotomy Headache and Psychological Derangement
试验速览
- 阶段
- 2 期
- 状态
- 已完成
- 入组人数
- 139
- 试验地点
- 1
- 主要终点
- Success Rate of Treatment in Mitigating Post-Craniotomy Headache (PCH).
研究概览
简要总结
This randomized multicenter study involves patients undergoing intracranial surgeries (Population) to evaluate whether a perioperative analgesia protocol including scalp block (SB) with dexmedetomidine (DEX) infusion (Intervention) reduces the incidence and severity of post-craniotomy headache (PCH) compared to standard opioid-based perioperative analgesia (Comparison). The study aims to determine if this Enhanced Recovery After Surgery (ERAS) approach mitigates postoperative pain, reduces opioid consumption, and improves psychological outcomes, including anxiety, depression, and sleep quality.
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
- Double (Participant, Investigator)
盲法说明
Both the investigators and the participants aren't aware of which arm the patient has been assigned to.
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
- •Patients undergoing supratentorial or intracranial surgery;
- •signed informed consent.
排除标准
- •History of chronic headache disorders;
- •allergy to study medications;
- •emergency surgeries;
- •inability to perform psychological or cognitive testing.
研究组 & 干预措施
ERAS Analgesia Group
Patients undergoing intracranial surgery receiving the suggested ERAS protocol.
干预措施: Scalp block with 0.5% plain Marcaine (Drug)
Standard Opioid-Based Group
Patients undergoing intracranial surgery receiving conventional analgesic management.
干预措施: Intraoperative Analgesia (Drug)
ERAS Analgesia Group
Patients undergoing intracranial surgery receiving the suggested ERAS protocol.
干预措施: dexmedetomidine (Drug)
结局指标
主要结局
Success Rate of Treatment in Mitigating Post-Craniotomy Headache (PCH).
时间窗: Immediately postoperative through 4 weeks of follow-up.
Evaluation of the incidence and severity of PCH using the Visual Analogue Scale (VAS) and the Headache Impact Test-6 (HIT-6).
次要结局
- Impact of Analgesic Regimen on Postoperative Cognitive Function (CF)(Assessed at three specific intervals: Baseline: Preoperatively (to establish the patient's normal function). POW2: Two weeks after surgery. POW4: Four weeks after surgery.)
研究者
Ahmed B. Abo elkheer
Lecturer of Anesthesiology, Pain, and ICU Department
Tanta University