A Study of efficacy of Ropivacaine Instillation Through Subgaleal Drain for Post Craniotomy Pain Management A Randomized Controlled Trial
试验速览
- 阶段
- 不适用
- 状态
- 尚未招募
- 发起方
- 入组人数
- 46
- 试验地点
- 1
- 主要终点
- To assess postoperative pain scores using the Visual Analog Scale (VAS) at
研究概览
简要总结
Post-craniotomy pain is frequently underestimated, yet evidence shows that most patients experience moderate to severe pain in the first 24 hours after surgery. Effective analgesia is essential, but the use of opioids and sedatives is limited because they can interfere with the neurological assessments required after brain surgery. Therefore, a safe, localized method of pain relief is needed.
This randomized controlled trial aims to evaluate the analgesic efficacy of instilling 15 mL of 0.25% Ropivacaine through the subgaleal drain—a space already created during craniotomy. This technique targets the innervated scalp tissues directly, offering localized analgesia with minimal systemic effects.
A total of 46 adult patients, undergoing elective supratentorial craniotomy, will be randomly assigned into two groups:
- Group R: Subgaleal instillation of Ropivacaine
- Group P: Standard IV Paracetamol 15 mg/kg every 6 hours
Postoperative monitoring will include VAS pain scores, time to first rescue analgesia, total analgesic use, sedation scores (RASS), recovery scores (Modified Aldrete), and adverse events such as nausea/vomiting. Rescue analgesia will be provided when VAS > 4.
The study aims to determine whether ropivacaine instillation provides better pain relief, prolongs time to rescue analgesia, reduces overall analgesic consumption, and enhances postoperative recovery, without affecting neurological evaluation.
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 盲法
- None
入排标准
- 年龄范围
- 18.00 Year(s) 至 70.00 Year(s)(—)
- 性别
- All
入选标准
- •Adults aged 18 to 70 years Patients undergoing supratentorial craniotomy ASA physical status I to III.
排除标准
- •Gcs less than 12 Allergic to local anesthetic Previous history of brain surgery.
结局指标
主要结局
To assess postoperative pain scores using the Visual Analog Scale (VAS) at
时间窗: time intervals 1,4,8,10,12, 24 hour
predefined time intervals (1,4,8,10,12, 24 hours)
时间窗: time intervals 1,4,8,10,12, 24 hour
o To evaluate the time to first rescue analgesia postoperatively
时间窗: time intervals 1,4,8,10,12, 24 hour
次要结局
- To assess total number of analgesics consumption within the first 24 hours(postoperatively)
研究者
Dr AKHIL A G
Shri B M patil medical college hospital and research centre
