Ultrasound-guided Subcostal Transversus Abdominis Plane Block in Gastric Cancer Patients Undergoing Laparoscopic Gastrectomy: A Randomized Controlled Double-blinded Study
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 入组人数
- 112
- 试验地点
- 1
- 主要终点
- Total fentanyl consumption during 24 hours
研究概览
简要总结
This prospective, randomized, single blinded study is designed to evaluate the postoperative analgesic efficacy of the ultrasound-guided subcostal transversus abdominis plane block in gastric cancer patients undergoing laparoscopic gastrectomy. We hypothesize that US guided subcostal TAP block with ropivacaine can significantly reduce postoperative opioid comparison in patients with laparoscopic gastrectomy.
详细描述
Adult patients undergoing elective laparoscopic gastrectomy are randomly allocated to receive subcostal TAP block (n=56) or not (n=56), in addition to a standard postoperative analgesic regimen comprising of IV fentanyl-based patient-controlled analgesia (PCA) and NSAIDs as required. At the end of surgery, the TAP group patients will receive bilateral subcostal TAP block under ultrasound guidance with 15ml of 0.375% ropivacaine bilaterally. Each patient was assessed by a blinded investigator at 6, 12, 24, and 48 h postoperatively. The primary outcome is total fentanyl consumption at 24 h after surgery.
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)
盲法说明
We plan to perform TAPB in patients under general anesthesia. Physicians not involved in this study will investigate the outcomes.
入排标准
- 年龄范围
- 18 Years 至 80 Years（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Patients scheduled to undergo elective laparoscopic gastrectomy under general anesthesia
- •American Society of Anesthesiologists (ASA) physical classification I-III
- •Consent to IV-patient controlled analgesia use
- •Willingness and ability to sign an informed consent document
排除标准
- •Do not understand our study
- •Allergies to anesthetic or analgesic medications
- •Wound infiltration analgesia for postoperative pain control
- •Infection or anatomic abnormality at the needle insertion site
- •Pregnancy/Breast feeder
- •Medical or psychological disease that can affect the treatment response
研究组 & 干预措施
Group T
Patients receiving bilateral subcostal TAP block.
干预措施: Ultrasound guided subcostal transversus abdominis plane block (TAPB) (Procedure)
Group T
Patients receiving bilateral subcostal TAP block.
干预措施: Ropivacaine 0.75% Injectable Solution (Drug)
Group T
Patients receiving bilateral subcostal TAP block.
干预措施: 21G 100 mm stimulator needle (Echoplex®, Vygon, Ecouen, France) (Device)
结局指标
主要结局
Total fentanyl consumption during 24 hours
时间窗: postoperative 24 hours
postoperative cumulative fentanyl consumption (mcg)
次要结局
- Rescue nonopioid(ketorolac, nefopam) analgesic requirement(postoperative 6, 12, 24, 48 hours)
- Total fentanyl consumption(postoperative 6, 12, 48 hours)
- Postoperative pain score(postoperative 6, 12, 24, 48 hours)
- occurrence of opioid-related side effects(postoperative 6, 12, 24, 48 hours)
研究者
Hojin Lee, MD
Clinical assistant professor
Seoul National University Hospital