Effect of Ultrasound-guided Transversus Abdominis Plane Block With Compound Lidocaine and Esketamine on Postoperative Pain in Patients Undergoing Colorectal Cancer Surgery: a Randomized Double-blind Controlled Trial
试验速览
- 阶段
- 不适用
- 入组人数
- 160
- 主要终点
- Postoperative opioid consumption
研究概览
简要总结
Purpose:
To explore effects of ultrasound-guided transversus abdominis plane block with compound lidocaine and esketamine on postoperative pain after colorectal cancer surgery.
详细描述
Poor post-surgical pain 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. Compared with ropivacaine, compound lidocaine injection has a better and longer analgesic activity since it contains menthol and ethanol with appropriate concentrations. However, whether compound lidocaine injection is efficiency in the transversus abdominis plane block for abdominal surgery lacks investigations. Herein, we will evaluate the efficacy of ultrasound-guided transversus abdominis plane (USG-TAP) block with compound lidocaine injection and esketamine for postoperative analgesia in patients undergoing colorectal 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
- Prevention
- 盲法
- Double (Investigator, Outcomes Assessor)
入排标准
- 年龄范围
- 20 Years 至 65 Years（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Subject is scheduled to undergo colorectal cancer surgery under general anesthesia
- •Subject's American Society of Anesthesiologists physical status is I-II.
- •The subject's parent/legally authorized guardian has given written informed consent to participate.
排除标准
- •Subject has a diagnosis of bronchial asthma, coronary heart disease, severe hypertension, renal failure or liver failure.
- •Subject has a diagnosis of Insulin dependent diabetes.
- •Subject is allergy and contraindication to local anesthetics or any components of local anesthetics.
- •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 of patient-controlled analgesia (PCA).
- •Subject is pregnant or breast-feeding.
- •Subject is obese (body mass index >30kg/m^2).
- •Subject is incapacity to comprehend pain assessment and cognitive assessment.
研究组 & 干预措施
Normal saline in transversus abdominis plane block
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 in transversus abdominis plane block
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 (Drug)
Compound lidocaine in transversus abdominis plane block
Before the induction of anesthesia, 0.4% compound lidocaine is used for bilateral transversus abdominis plane block in a volume of 20 mL of each side.
干预措施: Compound lidocaine (Drug)
Compound lidocaine and esketamine in transversus abdominis plane block
Before the induction of anesthesia, 0.4% compound lidocaine and 0.4mg/kg esketamine are used for bilateral transversus abdominis plane block in a volume of 20 mL of each side.
干预措施: Compound lidocaine (Drug)
Compound lidocaine and esketamine in transversus abdominis plane block
Before the induction of anesthesia, 0.4% compound lidocaine and 0.4mg/kg esketamine are used for bilateral transversus abdominis plane block in a volume of 20 mL of each side.
干预措施: Esketamine (Drug)
结局指标
主要结局
Postoperative opioid consumption
时间窗: 48 hours after surgery
Each patient was administered analgesics using a PCA (Patient-controlled analgesia) pump containing opioid in normal saline after leaving PACU (Postanesthesia care unit). Opioid cumulative consumption is recorded for 48 hours postoperatively.
次要结局
- Time of First Postoperative Analgesic Requirement(1 hour after surgery)
- Mean time until passage of flatus(96 hours after surgery)
- Diffusion area of local anesthetics after transversus abdominis plane block(30 minutes after transversus abdominis plane block)
- Pain Score (NRS)(48 hours after surgery)
- The level of cytokines in blood By ELISA kits(48 hours after surgery)
- The incidence of Side Effects(48 hours after surgery)
- Apfel score(The 1 day before the surgery)
- Normalized Area of Hyperalgesia Around the Incision(48 hours after surgery)
- Total Dose of First Postoperative Analgesic Requirement(1 hour after surgery)
- The level of chemokines in blood By ELISA kits(48 hours after surgery)
研究者
Guolin Wang
Professor
Tianjin Medical University General Hospital