Gall Bladder Bed Infiltration Analgesia
追踪信息 | |||
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首次提交日期 ICMJE | October 1, 2018 | ||
首次发布日期e ICMJE | October 3, 2018 | ||
最后更新发布日期 | October 3, 2018 | ||
预计研究开始日期 ICMJE | September 10, 2018 | ||
预计主要完成日期 | September 1, 2019 (主要结果测量的最终数据收集日期) | ||
目前主要观察指标 ICMJE |
The total postoperative analgesic consumption[ Time Frame: postoperative, for 24 hours ] ketorolac and morphine in mg . |
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原始主要观察测量 ICMJE | 与当前相同 | ||
目前的二级观察 ICMJE |
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描述性信息 | |||
简略标题 ICMJE | Gall Bladder Bed Infiltration Analgesia | ||
正式标题 ICMJE | The Effect of Gallbladder Bed Infiltration on Analgesia in Laparoscopic Cholecystectomy | ||
简要概况 | Early postoperative pain is a common complaint after elective laparoscopic cholecystectomy. Persistent acute postoperative pain is the dominating complaint and the primary reason for a prolonged stay after this procedure. This pain can be superficial incisional wound pain (somatic), deep visceral pain and/or post-laparoscopy shoulder pain (referred somatic), all of which may require systemic analgesia. Hypothesis: Laparoscopic pain can be superficial incisional wound pain (somatic pain), deep visceral pain and/or post-laparoscopy shoulder pain (referred somatic pain), so the block must be periportal for incisional wound pain, intraperitoneal to decrease pain caused by pneumoperitoneum, and of the bladder bed to decrease the deep visceral pain. This combination can give the maximum analgesia after laparoscopic cholecystectomy. |
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详细说明 | Bladder bed irrigation with Bupivacaine was an effective method for reducing pain during the first postoperative hours after laparoscopic cholecystectomy. The intraperitoneal administration of lidocaine solution (total dose, 3.5 mg/kg) will be done as follows: immediately after creation of the pneumoperitoneum, the surgeon will spray 50-75 ml of the total solution on the upper surface of the liver under the right sub-diaphragmatic space, and another 50-75ml of the total solution under the left sub-diaphragmatic space. In order to allow the sprayed solution to diffuse under the diaphragmatic space, the Trendelenburg position will be maintained for 2 minutes. In the infiltration group will be administrating 5 ml lidocaine at each port site before incision, then the surgeon will spray 50-75 ml of the total solution on the upper surface of the liver under the right sub-diaphragmatic space, and another 50-75ml of the total solution under the left sub-diaphragmatic space then 50 ml will be infiltrated in the bladder bed after clamping of the cystic duct and cystic artery. CO2 will be humidified and wormed. | ||
研究类型 ICMJE | Interventional | ||
研究阶段 | N/A | ||
研究设计 ICMJE | 分配: Randomized 干预模型: Parallel Assignment 干预模型描述: 盲法: Interventional 盲法描述:the infiltration cocktail of local anesthetic will be replaced by saline in the same volume. 主要目的: Prevention |
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适用条件 ICMJE | |||
干预项目 ICMJE |
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研究工具 |
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招募信息 | |||
招募状态 ICMJE | Recruiting | ||
预计入组 ICMJE |
88 | ||
原始预计入组 ICMJE | 与当前相同 | ||
预计研究完成日期 | September 1, 2019 | ||
预计主要完成日期 | September 1, 2019 (主要结果测量的最终数据收集日期) | ||
合格标准 ICMJE | Inclusion Criteria: - Scheduled to undergo elective laparoscopic cholecystectomy. - American Society of Anesthesiologists physical status (ASA) I or II. Exclusion Criteria: 1. Patient in receipt of analgesics or sedatives 24 h before scheduled surgery. 2. Patient with spillage or cholelithiasis with known common bile duct pathology. 3. Body Mass Index > 40 Kg/m2. 4. Patient underlying severe systemic disease. 5. Patient with a history of abdominal surgery, a chronic pain disorder other than gallbladder disease or allergy to lidocaine. | ||
性别 |
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年龄 | 最小年龄:20 Years ,最大年龄:60 Years | ||
接受健康的志愿者 | 没有 | ||
可入组国家 ICMJE | Egypt | ||
管理信息 | 数据检测委员会 | ||
研究涉及美国FDA监管的产品 |
研究美国FDA监管的药品: No 研究涉及美国FDA监管的设备产品: No |
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IPD 共享声明 |
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责任方 | Alaa Mazy,Mansoura University | ||
研究赞助商 ICMJE | Alaa Mazy | ||
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研究员 ICMJE |
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PRS 账户 | Mansoura University | ||
验证日期 | October 2018 | ||
ICMJE 国际医学期刊编辑委员会和 世界卫生组织 ICTRP 要求的元素 |