Opioid Sparing Effect of Erector Spinae Block in Patients Undergoing Total Abdominal Hysterectomy; A Randomized Control Trial
试验速览
- 阶段
- 4 期
- 状态
- 招募中
- 发起方
- 入组人数
- 60
- 试验地点
- 1
- 主要终点
- Total Intra-operative Fentanyl consumption
研究概览
简要总结
Hystrectomy is a surgical procedure that involves removal of uterus from the body of patient using a lower abdominal incision. This is an extremely painful procedure which causes discomfort and greatly increases opioids consumption in the peri-operative period. This can be reduced by using nerve blocks such as Erector spinae plane block.
详细描述
Total abdominal hystrectomy is associated with significant pain due to large abdominal incision and significant surgical dissection. This greatly increases the consumption of Opioid in the peri-operative period. High dose opioid consumption is associated with constipation, nausea, vomiting and respiratory depression. This significantly hampers post operative recovery. Fascial plane blocks such as Erector spinae block provides significant analgesia greatly reducing opioid consumption and there by reducing the associated side effects.
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Parallel
- 主要目的
- Treatment
- 盲法
- Double (Participant, Outcomes Assessor)
入排标准
- 年龄范围
- 16 Years 至 80 Years（Child, Adult, Older Adult）
- 性别
- Female
- 接受健康志愿者
- 是
入选标准
- •American Society of Anesthesiologists (ASA) class: I, II and III .
- •Elective Hysterectomy under General Anesthesia.
排除标准
- •Lack of consent
- •Body mass index >35 kg/m2
- •Allergic to study medicine
- •Opioid abuse or misuse disorder
- •Chronic pain
研究组 & 干预措施
Erector spinae group
Patients in this group will receive bilateral erector spinae block at T10 level using 30ml of 0.25% Bupivacaine before surgical incision.
干预措施: Erector Spinae (ESP) Block with Bupivacaine (Marcaine®) (Drug)
Placebo
Patient in this group will receive Norma saline in Erector spinae block at T10 level bilaterally before surgical incision.
干预措施: Placebo (Drug)
结局指标
主要结局
Total Intra-operative Fentanyl consumption
时间窗: From surgical incision till end of surgery
次要结局
- Total amount of IV Tramadol consumed in post operative period(First 24 hours after surgery)
- Post operative pain score(Baseline that is pain score upon arrival in post anesthesia care unit in the post operative period and then at 1hours ,2 hours ,4 hours,6 hours,12 hours and 24 hours in the post operative period)
研究者
Waqas Anjum
Principal Investigator
Kulsoom International Hospital