Comparison of Efficacy of Patient Controlled Epidural Analgesia Versus Continuous Epidural Infusion Following Thoraco-abdominal Surgeries in Cancer Patients
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 入组人数
- 70
- 试验地点
- 2
- 主要终点
- To compare the pain scores during rest and movement with continuous epidural infusion (CEI) vs. patient controlled epidural analgesia (PCEA)
研究概览
简要总结
This study aims to compare the efficacy of pain control, the consumption of local anesthetic and opioids, side effects, and patient satisfaction between continuous epidural infusion and patient controlled epidural analgesia after thoraco-abdominal surgeries in cancer patients.
详细描述
Aim-
- To compare the pain scores during rest and movement with continuous epidural infusion (CEI) vs. patient controlled epidural analgesia (PCEA)
- To compare the incidence of side effects between 2 groups
- Comparison of local anaesthetic and opioids requirement by PCA attempts and also rescue analgesia requirement.
- To compare patient satisfaction with the two different modalities of pain management
Sample size- Based on our hospital data for postoperative pain management after thoraco-abdominal surgeries, it was found that 69.7 % patients experience moderate to severe pain (pain score 4-10) on first day postoperatively.
Considering a 50% reduction as meaningful, group sample size of 62 with 31 in each group was calculated using a chi square test. Assuming a 10% loss to follow up or drop outs from study we require 35 in each group with total sample size of 70.
Variables- age, sex, demographic factors, surgery, duration of surgery, pain score, nausea score, hypotension episode, pruritis, Vomiting episode, patients satisfaction score, requirement of rescue analgesia.
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Crossover
- 主要目的
- Supportive Care
- 盲法
- Double (Participant, Investigator)
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
- •All adult patients, American Society of Anaesthesia class I-II, posted for thoraco-abdominal surgeries and planned for epidural catheter insertion for perioperative pain management, will be included. The surgeries will include gastrectomy, radical & revision cholecystectomy, whipples procedure, pancreatectomy, lobectomy, metastectomy, pneumonectomy will be included.
排除标准
- •Patients with contraindication to epidural catheter placement or use of opioids or local anesthetic
- •Patients with contraindication to use of rescue analgesia like paracetamol and diclofenac both in postoperative period
- •Multiple incision not covered with epidural like TTE, THE
- •Patients with failed epidural insertion
- •Patients with epidural band not covering the incision sites completely
- •Patient with hemodynamic instability leading to inability to use epidural within the first 4-6 hours.
- •Patient shifted on ventilator or needing ventilator support the within first 6-12 hours.
结局指标
主要结局
To compare the pain scores during rest and movement with continuous epidural infusion (CEI) vs. patient controlled epidural analgesia (PCEA)
时间窗: 72 hours
pain scores to be assessed using Numerical Rating scale(1-10)
次要结局
- To compare patient satisfaction between the two groups using Verbal Rating scale(36 hours and 72 hours)
- To assess the incidence of side effects in both groups including hypotension, motor weakness, pruritus, nausea, vomiting and any other(72 hours)
研究者
parmanand jain
Professor
Tata Memorial Centre