Impact of Ultrasound-Guided Transversus Abdominis Plane Block on Postoperative Nausea and Vomiting and Early Outcome After Laparoscopic Bariatric Surgery: a Randomized Double-Blinded Controlled Trial
试验速览
- 阶段
- 不适用
- 入组人数
- 90
- 主要终点
- Postoperative nausea and vomiting
研究概览
简要总结
To explore and compare Ultrasound-Guided Transversus Abdominis Plane Block on Postoperative nausea and vomiting and Early Outcome After Laparoscopic Bariatric Surgery To evaluate and examine TAPB can reduce the application of intraoperative and postoperative opioids and the duration of analgesia
详细描述
Poor postoperative nausea and vomiting control is a leading factor that hinders the physical rehabilitation, and causes acute cognitive impairment and chronic pain syndrome. Recently, the multimodal analgesia strategies to minimise opioid-related side effects are highly desirable in open surgical procedures. The transversus abdominis plane block is a novel technique involving injection of local anaesthetic between the internal oblique and the transversus abdominis muscles of the abdominal wall. Although ropivacaine is most commonly used for this technique, the analgesic duration remains not dissatisfied. Herein, investigators will evaluate the efficacy of ultrasound-guided transversus abdominis plane(USG- TAP) block with ropivacaine in Laparoscopic Bariatric Surgery.
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
- Double (Investigator, Outcomes Assessor)
盲法说明
Double (Investigator, Outcomes Assessor)
入排标准
- 年龄范围
- 20 Years 至 60 Years（Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Subject is scheduled to undergo Laparoscopic Bariatric Surgery
- •Subject's American Society of Anesthesiologists physical status is I-III.
- •BMI>35kg/m2
- •The subject's parent/legally authorized guardian has given written informed consent to participate
排除标准
- •Subject has a diagnosis of renal or liver failure.
- •Subject has a diagnosis of mental illness
- •Subject is allergy and contraindication to Ropivacaine.
- •Subject has a history of chronic pain, a history of alcohol or opioid abuse, pre-existing therapy with opioids, intake of any analgesic drug within 48 hours before surgery.
- •Subject has any contraindication for the use
- •Subject is pregnant or breast-feeding.
研究组 & 干预措施
Normal Saline
Before the induction of anesthesia, normal saline is used for bilateral transversus abdominis plane block in a volume of 20 mL of each side.
干预措施: Normal saline (Drug)
Ropivacaine at high concentration
Before the induction of anesthesia, 0.375% Ropivacaine is used for bilateral transversus abdominis plane block in a volume of 20 mL of each side
干预措施: Ropivacaine at high concentration (Drug)
Ropivacaine and dexamethasone
Before the induction of anesthesia, 0.375% Ropivacaine and 5.0mg dexamethasone are used for bilateral transversus abdominis plane block in a volume of 20 mL of each side
干预措施: Ropivacaine and dexamethasone (Drug)
结局指标
主要结局
Postoperative nausea and vomiting
时间窗: 72 hours after surgery
The Apfel score was recorded for evaluating risk for developing postoperative nausea and vomiting (PONV).
次要结局
- cumulative Sufentanyl Consumption during surgery(during surgery)
- Mean time until passage of flatus(72 hours after surgery)
- Diffusion area of local anesthetics after transversus abdominis plane block(30 minutes after transversus abdominis plane block)
- Time of First Postoperative Analgesic Requiremen(1hour after surgery)
- Apfel score(The 1 day before the surgery)
- The incidence of Side Effects(48 hours after surgery)
- Total Dose of First Postoperative Analgesic Requirement(1hour after surgery)
- cumulative Sufentanyl Consumption after surgery(48 hours after surgery)
- Time to ambulation(12 hours after surgery)
- Normalized Area of Hyperalgesia Around the Incision(48 hours after surgery)
研究者
Guolin Wang
Professor
Tianjin Medical University General Hospital