Bilateral Ultrasound Guided Erector Spinae Plane Block Versus Transversus Abdominis Plane Block on Post-operative Analgesia After Total Abdominal Hysterectomy
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 入组人数
- 48
- 试验地点
- 2
- 主要终点
- The total amount of morphine given to each patient
研究概览
简要总结
- Abdominal hysterectomy is an open surgical procedure associated with considerable post-operative pain. Narcotics are often required during patient recovery but can result in adverse side effects. Transversus abdominis plane block(TAP block) is a regional anesthetic technique that is found to be effective as post-operative analgesia after total abdominal hysterectomy. Recently, erector spinae plane block(ESP)block is found to be safe, and simple regional anesthetic technique that decrease total opioid consumption in patient undergoing breast, or abdominal surgery.
- The aim is to compare the efficacy of bilateral erector spinae plane block, and bilateral transversus abdominis plane block on postoperative analgesia in patients after abdominal hysterectomy under general anesthesia, and their need for opioid.
Hypothesis
- Null hypothesis (H0): No difference between the analgesic effects of bilateral erector spinae plane block, and bilateral transversus abdominis plane block in patients after abdominal hysterectomy under general anesthesia.
- Alternative hypothesis (H1): There are difference between the analgesic effects of bilateral erector spinae plane block, and bilateral transversus abdominis plane block in patients after abdominal hysterectomy under general anesthesia.
详细描述
Sample size: Assuming that Mean±SD of reduced pain scores in erector spinae plane block is 4.7±3.7 versus 2.5±1 in transversus abdominis plane block.So, the total sample size is 48 cases (24 in each group) using Open Source Statistics for Public Health (open Epi) with confidence interval 95% and power of test is 80%.
d) Method of sample collection:
Forty eight female patients will be divided into two groups by a computer-generated randomization table:
Group (ES) (n=24): will receive bilateral ultrasound guided erector spinae plane block with each block 20 ml of bupivacaine 0.375% plus 5ug/ml adrenaline (1:200000) at the level of T9.
Group (TA) (n=24): will receive bilateral ultrasound guided transversus abdominis plane block with each block 20 ml of bupivacaine 0.375% plus 5ug/ml adrenaline (1:200000).
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
- 40 Years 至 60 Years（Adult）
- 性别
- Female
- 接受健康志愿者
- 是
入选标准
- •Female Patient.
- •Patient acceptance.
- •Age (40-60) years old.
- •American Society of Anaesthesiologist (ASA) I / II
- •Elective total abdominal hysterectomy under general anesthesia.
- •patient With Body Mass Index (BMI) (25-35kg/m²)
排除标准
- •Patient refusal.
- •Local infection at site of puncture.
- •Altered mental status.
- •History of allergy to study drugs ( bupivacaine, morphine).
- •Patients with chronic pain.
- •Patients with severe hepatic or kidney impairment.
- •Patients having a history of hematological disorders, including coagulation abnormality.
研究组 & 干预措施
Erector Spinae Plane Block
Bilateral Ultrasound Guided Erector Spinae Plane Block
干预措施: 1) Ultrasound guided Erector spinae block (Procedure)
transversus abdominis plane block
Ultrasound guided transversus abdominis plane block
干预措施: Ultrasound guided transversus abdominis plane block (Procedure)
结局指标
主要结局
The total amount of morphine given to each patient
时间窗: the first 24 hours postoperative.
The total amount of morphine given to each patient during the first 24h of postoperative period
The time to first call to analgesia (morphine)
时间窗: first call to morphine up to 24 hours postoperative.
morphine (rescue analgesic) will be given if VAS\>3.
Pain intensity using Visual analogue Scale (VAS) (McCormack et al., 1988).
时间窗: at 30 minutes postoperative.
1- Pain intensity using Visual analogue Scale (VAS) (McCormack et al., 1988). A commonly used visual analog scale is a 10-cm line labeled with "worst pain imaginable" on the right border and "no pain" on the left border. The patient is instructed to make a mark along the line to represent the intensity of pain currently being experienced. VAS score will be assessed at 30 minutes, 2hs, 4hs, 6hs, 12hs, and 24hs postoperative and IV increment of 3mg morphine (rescue analgesic) will be given if VAS\>3.
Pain intensity using Visual analogue Scale (VAS)
时间窗: at 24 hours postoperative.
visual analogue scale is a 10-cm line labeled with "worst pain imaginable" on the right border and "no pain" on the left border.
"Number of Participants with nausea, Vomiting, nausea or vomiting, hypotension, bradycardia, or any other complication"
时间窗: Up to 24 hours postoperative.
"Number of Participants with nausea, Vomiting, nausea or vomiting, hypotension, bradycardia, or any other complication"
次要结局
- Over all patient satisfaction(all over 24 hours postoperative)
研究者
Alshaimaa Abdel Fattah Kamel
lecturer of Anaesthesia ,and surgical intensive care
Zagazig University