Effect of Ultrasound-guided Transversus Abdominis Plane Block With Compound Lidocaine on Postoperative Pain in Patients Undergoing Gynecological Laparotomy：a Randomized Double-blind Controlled Trial
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 入组人数
- 164
- 试验地点
- 1
- 主要终点
- Pain Score (NRS)
研究概览
简要总结
Purpose:
To explore effects of ultrasound-guided transversus abdominis plane block with compound lidocaine on postoperative pain after gynecological laparotomy.
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 open sugery lacks investigations. Herein, we will evaluate the efficacy of ultrasound-guided transversus abdominis plane (USG-TAP) block with compound lidocaine injection for postoperative analgesia in patients undergoing gynecological laparotomy.
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 60 Years（Adult）
- 性别
- Female
- 接受健康志愿者
- 否
入选标准
- •Subject is scheduled to undergo gynecological laparotomy 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 at low-concentration 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 at low concentration (Drug)
Compound lidocaine at high-concentration in transversus abdominis plane block
Before the induction of anesthesia, 0.6% 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 at high concentration (Drug)
结局指标
主要结局
Pain Score (NRS)
时间窗: 72 hours after surgery
The pain score at rest or after movement was evaluated by pain 11-point numerical rating scale (NRS): 0 = no pain, 10 = greatest imaginable pain.
次要结局
- Cumulative Sufentanyl Consumption(72 hours after surgery)
- Normalized Area of Hyperalgesia Around the Incision(72 hours after surgery)
- Time of First Postoperative Analgesic Requirement(1 hour after surgery)
- Total Dose of First Postoperative Analgesic Requirement(1 hour after surgery)
- Occurrence of Side Effects(72 hours after surgery)
- The onset time of sensory block(30 minutes after transversus abdominis plane block)
- Diffusion area of local anesthetics after transversus abdominis plane block(30 minutes after transversus abdominis plane block)
- Apfel score(The day before the surgery)
- Mean time until passage of flatus(72 hours after surgery)
研究者
Guolin Wang
Professor
Tianjin Medical University General Hospital