Comparative study of intrathecal morphine versus thoracic epidural for post operative analgesia in patients undergoing hepato pancreato biliary surgery : A Randomised Control Trial
试验速览
- 阶段
- 4 期
- 状态
- 尚未招募
- 发起方
- 入组人数
- 88
- 试验地点
- 1
- 主要终点
- To evaluate total opioid consumption over 48 hours postoperatively in adult patients undergoing hepatopancreatobiliary surgeries, comparing those receiving intrathecal morphine with those receiving thoracic epidural analgesia.
研究概览
简要总结
This study aims to compare two common methods of pain relief—intrathecal morphine and thoracic epidural analgesia—in patients recovering from hepato-pancreato-biliary (HPB) surgery. Eighty-eight adult patients will be randomly assigned to receive either a single injection of intrathecal morphine or a continuous thoracic epidural infusion for postoperative pain control. The main focus is to measure total opioid use in the first 48 hours after surgery, along with side effects, time to additional pain relief, fluid needs, and hospital stay. The goal is to find out whether intrathecal morphine can provide pain relief that is just as effective and safe as the epidural method, while being simpler to use and more comfortable for patients during their recovery.
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
- •Patients undergoing Elective hepato-pancreato-biliary surgery American Society of Anaesthesiologists status I, II, III.
- •BMI – 18-24kg/m2.
排除标准
- •Patients with contraindications to neuraxial anesthesia (e.g., coagulopathy, infection at injection site, severe spine deformity, known allergy or hypersensitivity).
- •Chronic opioid use or opioid dependence prior to surgery.
- •Patients who couldn’t understand the technique of operating the PCA pump
- •Patients who are not extubated within 48hours after surgery.
结局指标
主要结局
To evaluate total opioid consumption over 48 hours postoperatively in adult patients undergoing hepatopancreatobiliary surgeries, comparing those receiving intrathecal morphine with those receiving thoracic epidural analgesia.
时间窗: Total opioid consumption after 48 hours
次要结局
- To evaluate the incidence of analgesia-related complications such as hypotension, vomiting, respiratory depression among both groups
- To assess time to first rescue analgesia among both groups
- To compare the length of hospital stay among both groups(Till the patient is discharged from the hospital)
- To compare peri-operative fluid use among both groups
研究者
Dr Santosh
AIIMS Patna