Epidural Morphine for Geriatrics Undergoing Lower Abdominal Cancer Surgery: a Dose Response Study
试验速览
- 阶段
- 4 期
- 状态
- 已完成
- 入组人数
- 96
- 试验地点
- 1
- 主要终点
- Total Patient-controlled Analgesia (PCA) Morphine Sulphate (MS) Consumption.
研究概览
简要总结
This a clinical trial that evaluates the efficacy and safety of three different doses of morphine, namely 1.5 mg, 3 mg and 4.5 mg, via the epidural route regarding reducing pain in elderly patients after a cancer surgery in the lower abdomen
详细描述
Acute postoperative pain is a common complaint for several days after surgery. However, acute postoperative pain remains even more under controlled in elderly patients, especially those with cognitive impairment and malignancy. Geriatric population is reported to be at higher risk for unwanted side effects from analgesic treatments compared to younger patients due to different major risk factors such as: decline in organ function, polypharmacy, pharmacokinetics, drug sensitivity, and frailty. Despite of the higher risk of opioids, especially morphine, causing toxicity and adverse effect; they are still the cornerstone treatment of severe acute postoperative pain. Morphine in those patients is very likely to cause toxicity because of accumulation of its active metabolites compared to other opioids with fewer or no active metabolites. Epidural morphine is an effective route for an effective drug. Furthermore, unwanted side effects with neuraxial opioids are minor and managed easily. Regarding clinical outcomes, clinical studies showed a lot of improvements associated with postoperative opioid analgesia. Now, there is a clinical necessity to achieve the best management of acute postoperative pain in elderly patients with the least possibility of adverse side effects. We aim in this randomized, assessor blinded, clinical trial at Assuit University to determine the optimum dose of epidural morphine for the highest control of acute postoperative pain in geriatrics who are planned to have lower abdominal cancer surgery.
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
- Single (Outcomes Assessor)
入排标准
- 年龄范围
- 60 Years 至 100 Years（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Men and women aged ≥ 60 years, who are planned to undergo lower abdominal cancer surgery.
- •2- ASA I and II classifications.
- •Surgeries via infra-umbilical abdominal incision is considered eligible.
排除标准
- •Patient refusal.
- •Patients who are morbidly obese (body mass index ≥ 40 kg/m2).
- •Those with contraindications to neuraxial analgesia. 4- psychiatric illness that would interfere with the perception and the assessment of pain.
研究组 & 干预措施
Group A
A total volume of 10 mL injection: 5 mL of bupivacaine hydrochloride 0.125% with 1.5 mg of preservative-free morphine diluted in 5 mL preservative-free normal saline by the hospital pharmacist.
干预措施: 1.5 mg of Morphine Sulfate (Drug)
Group C
A total volume of 10 mL injection: 5 mL of bupivacaine hydrochloride 0.125% with 4 mg of preservative-free morphine diluted in 5 mL preservative-free normal saline by the hospital pharmacist.
干预措施: 4.5 mg of Morphine Sulfate (Drug)
Group B
A total volume of 10 mL injection: 5 mL of bupivacaine hydrochloride 0.125% with 3 mg of preservative-free morphine diluted in 5 mL preservative-free normal saline by the hospital pharmacist.
干预措施: 3 mg of Morphine Sulfate (Drug)
Group D
A total volume of 10 mL injection 5 mL of bupivacaine hydrochloride 0.125% diluted in 5 mL preservative-free normal saline by the hospital pharmacist.
干预措施: Normal saline (Drug)
结局指标
主要结局
Total Patient-controlled Analgesia (PCA) Morphine Sulphate (MS) Consumption.
时间窗: 72 hours
The mean total PCA morphine consumption (mg) in the first 72 hr. postoperatively
次要结局
- Visual Analog Scale(72 hours)
- Modified Ramsay Sedation Scale(Modified Ramsay Sedation Scale at 2 hours postoperative)
- Nausea Score(72 hours)
- Vomiting Score(72 hours)
- Pruritus Score(72 hours)
研究者
Muhammad Mostafa Shawqi Abdelnasser
Anesthesia resident at South Egypt Cancer Institute
Assiut University