Ultrasound-guided-transversus Abdominis Plane(TAP) Block Versus Local Anesthetic(LA) Infiltration-the Effectiveness of Post-operative Pain Control in the Abdominal Surgery
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 入组人数
- 108
- 试验地点
- 1
- 主要终点
- Opioid Consumption
研究概览
简要总结
Postoperative analgesia is an important part of the anesthetic care. According to the recent studies, multimodal analgesia can provide better analgesia & patient satisfaction with fewer side effect. For example, combining intravenous, intramuscular or oral analgesics with transversus abdominis plane (TAP) block or local anesthetic (LA) infiltration as the multimodal analgesia, can furnish a more effective pain control after the abdominal surgery.
For abdominal surgery, both local infiltration and TAP block target on relieving somatic pain. Local anesthetic wound infiltration is easy to perform with low risk. As the advancement of ultrasound technology, performing the TAP block also becomes easier, safer and more accurate. But whether LA infiltration or TAP block is better for the multimodal analgesia regimen remains unclear.
This study is to compare the postoperative pain score, opioid consumption, side effects, and quality of recovery between these two analgesic methods in patients undergoing abdominal surgery. The investigators hypothesized that TAP block may be more effective than LA infiltration as a part of the multimodal analgesia, and can improve the recovery after the abdominal surgery.
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Parallel
- 主要目的
- Supportive Care
- 盲法
- Triple (Participant, Care Provider, 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
- •Adult (20~65y/o)
- •American Society of Anesthesiologists (ASA) physical status I~II
- •Patients scheduled for regular abdominal surgery under general anesthesia
排除标准
- •ASA physical status ≥ 3
- •Allergy to morphine or local anesthetics
- •Morphine tolerance
- •Drug abuse or addiction
- •Bleeding tendency
研究组 & 干预措施
TAP block
postoperative analgesia with sono-guided transversus abdominis plane block and intravenous patient controlled analgesia (IV-PCA). Bilateral sono-guided TAP block will be performed after the induction of general anesthesia. 20 ml of 0.25% ropivacaine will be injected to the transversus abdominis plane under ultrasound guidance at each side (total 40 ml). IV-PCA with morphine will be ready for postoperative pain control at the end of the surgery.
干预措施: transversus abdominis plane block (Procedure)
TAP block
postoperative analgesia with sono-guided transversus abdominis plane block and intravenous patient controlled analgesia (IV-PCA). Bilateral sono-guided TAP block will be performed after the induction of general anesthesia. 20 ml of 0.25% ropivacaine will be injected to the transversus abdominis plane under ultrasound guidance at each side (total 40 ml). IV-PCA with morphine will be ready for postoperative pain control at the end of the surgery.
干预措施: Patient controlled analgesia (Procedure)
Local infiltration
postoperative analgesia with local anesthetics infiltration at surgical wound and intravenous patient controlled analgesia (IV-PCA). 20 ml of 0.5% ropivacaine will be injected at the surgical wound by the surgeon before the closure of wound. IV-PCA with morphine will be ready for postoperative pain control at the end of the surgery.
干预措施: local infiltration (Procedure)
Local infiltration
postoperative analgesia with local anesthetics infiltration at surgical wound and intravenous patient controlled analgesia (IV-PCA). 20 ml of 0.5% ropivacaine will be injected at the surgical wound by the surgeon before the closure of wound. IV-PCA with morphine will be ready for postoperative pain control at the end of the surgery.
干预措施: Patient controlled analgesia (Procedure)
PCA only
postoperative analgesia with intravenous patient controlled analgesia. IV-PCA with morphine will be ready for postoperative pain control at the end of the surgery.
干预措施: Patient controlled analgesia (Procedure)
结局指标
主要结局
Opioid Consumption
时间窗: postoperative 48 hour
opioid consumption of the participants will be followed at postoperative 1, 6, 12, 24, 36, 48 hour (up to 48 hours).
Pain Score (NRS: Numerical Rating Scale)
时间窗: postoperative 24 hour dynamic
pain scores of the participants will be followed at postoperative 1, 6, 24, 48 hour (up to 48 hours). (NRS: from 0 to 10, 0 = no pain, 10 = the worst pain) The higher score idicates the worse outcome.
次要结局
- Sedation Scale(postoperative 1, 6, 24, 48 hour)
- Nausea and Vomiting Categorical Score(postoperative 1, 6, 24, 48 hour)
- Rescue Antiemetics Use(postoperative 1, 6, 12, 24, 36, 48 hour)
- Time to the First Request of Analgesics(an expected average of 5 days)
- Heart Rate Variability(preoperative, postoperative 1 hour and 1 day)
- Length of Hospital Stay(an expected average of 5 days)
- Rescue Analgesic Use(postoperative 1, 6, 12, 24, 36, 48 hour)
- Time to Flatus(an expected average of 5 days)
- Quality of Recovery 40(postoperative 48 hour)
- Pruritus(postoperative 1, 6, 24, 48 hour)
- Number of Participants With Intervention-related Complication(an expected average of 5 days)
研究者
hsiao chien tsai
fellow researcher
Taipei Medical University Hospital