The Effect Of Ultrasound-guided Modified Pectoral Nerves Block Versus Ketamine Plus Magnesium Infusion On Perioperative Analgesic Profile In Major Breast Cancer Surgeries: Randomized Controlled Study
试验速览
- 阶段
- 3 期
- 发起方
- 入组人数
- 75
- 试验地点
- 1
- 主要终点
- total morphine requirements
研究概览
简要总结
Background: Postoperative pain is one of the greatest patient concerns following surgery. However, general anesthesia cannot provide adequate postoperative pain control and the routine use of parenteral opioids aggravates postoperative sedation, nausea, emesis, impaired oxygenation and depressed ventilation.
Hypothesis:
The investigators assume that both ultrasound guided Modified Pecs Block and combination of Ketamine and Magnesium sulphate infusion can achieve better analgesia in major breast cancer surgery in the form of reducing total amount of intraoperative fentanyl requirement and reducing postoperative morphine requirement and improvement of postoperative VAS scores both at rest and during shoulder movement so we plan this study to evaluate this assumption
详细描述
Surgery on the chest wall is relatively common and can be associated with significant postoperative discomfort and pain; and one of the most common surgical sites on the chest wall is the breast, with the main indication for breast surgery being breast cancer. Breast cancer has continued to be the most common cancer in females, accounting for approximately 31% of all newly detected cancer cases in the female population, worldwide. (1, 2) Thousands of patients undergo surgery in the mammary and axillary regions every year, and these procedures tend to cause significant acute pain and may develop in to cases of chronic pain in 25-60% of cases. (3) Pain can be controlled using systemic opioids which have a respiratory depressant effect and causing nausea and vomiting.
Also can be controlled using epidural catheter that can cause haemodynamic instability, so we are searching about how to devrease pain with less complications.
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Parallel
- 主要目的
- Prevention
- 盲法
- Single (Outcomes Assessor)
入排标准
- 年龄范围
- 18 Years 至 65 Years（Adult, Older Adult）
- 性别
- Female
- 接受健康志愿者
- 否
入选标准
- •female patients with American society of Anesthesia classification(ASA) II physical status undergoing major breast cancer surgery with axillary evacuation under general anesthesia.
- •Patients' age from18 to 65 Years.
- •Body mass index (BMI) are from 20 to 40 kg/m2.
排除标准
- •Pregnant patients
- •Patients having sensitivity or contraindication to test drugs or regional anesthesia.
- •severe respiratory or cardiac disorders.
- •history of psychological disorder.
- •chronic pain .
- •significant liver or renal insufficiency. .
研究组 & 干预措施
pectoral nerves block group
modified pectoral nerves block was performed on the side of surgery
干预措施: pectoral nerves block group (Procedure)
Ktamine plus Magnesium group
Patients received 40 mg/kg of magnesium sulphate infusion in 100cc normal saline, as a bolus dose, in addition to 0.2mg/kg of ketamine as a bolus dose, 15 min before the induction of general anesthesia. This was followed by intraoperative continuous infusion of 10 mg/kg/h of magnesium sulphate combined with infusion of 0.1mg/kg/h ketamine that was started before skin incision and continued until completion of skin closure via infusion pump
干预措施: Ketamine plus magnesium group (Drug)
Control Group
Normal saline infusion with similar rate and volume to KM infusion was used as a placebo
干预措施: Control group (Drug)
结局指标
主要结局
total morphine requirements
时间窗: 24 hours postoperatively
calculating the total dose of morphine consumed in postoperative analgesia
次要结局
- fentanyl consumption(intraoperative period)
- Nausea and vomiting(during the first post-operative 24 hours)
- Visual analogue scale score(immediately after recovery and then at 1, 4, 8, 12, and 24 hours postoperatively.)
- Sedation score(A sedation level recorded upon arrival to the PACU and at 1, 4, 8, 12, and 24 hours postoperatively.)
研究者
Ahmed Salah Ahmed Abd Elgalil
Lecturer of Anesthesia and pain medicine
National Cancer Institute, Egypt