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Gall Bladder Bed Infiltration Analgesia

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合作者:
信息的提供 (责任方):
Alaa Mazy,Mansoura University
October 1, 2018
October 3, 2018
October 3, 2018
September 10, 2018
September 1, 2019   (主要结果测量的最终数据收集日期)
The total postoperative analgesic consumption[ Time Frame: postoperative, for 24 hours ]
ketorolac and morphine in mg .

与当前相同
  • The time to the first request of analgesia[ Time Frame: postoperative, for 24 hours ]
    hours
  • The intraoperative fentanyl requirements.[ Time Frame: intraoperative ]
    microgram
  • postoperative pain score: VAS[ Time Frame: postoperative at 0, 2, 4, 8, 12, 16 and 24 hours ]
    visual analog score from 0-10, zero is no pain, 10 is the most imaginable pain,
  • heart rate[ Time Frame: basal and intraoperatively every 30 minutes, then at 0, 2, 4, 8, 12, 16 and 24 hours post-operatively. ]
    beat/ minute
  • mean blood pressure[ Time Frame: basal and intraoperatively every 30 minutes, then at 0, 2, 4, 8, 12, 16 and 24 hours post-operatively. ]
    mmHg
  • incidence of vomiting[ Time Frame: postoperatively, during the first 24 hours ]
    number
  • the sleep quality[ Time Frame: postoperatively, after the first night. ]
    through a score 0-2, where 0= good quite sleep, 1= fair sleep, 2= bad quality of sleep.
  • Patient satisfaction regards analgesia:[ Time Frame: postoperative after 24 hour. ]
    using visual analog score from 0-10. zero = no satisfaction, 12= maximum satisfaction.
  • Surgeon satisfaction regards the technique:[ Time Frame: postoperative within 1 hour. ]
    using visual analog score from 0-10. zero = no satisfaction, 10= maximum satisfaction.
 
Gall Bladder Bed Infiltration Analgesia
The Effect of Gallbladder Bed Infiltration on Analgesia in Laparoscopic Cholecystectomy

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.

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.
Interventional
N/A
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
  • Drug: the infiltration group
    15-20 ml periportal, 50 ml in gallbladder bed, The rest (about 150 ml in 70 Kg patient) will be intraperitoneal
  • Drug: the control group
    the 50 ml prepared for gallbladder bed infiltration will be replaced by saline.
  • Active Comparator: the infiltration group
    a cocktail of 5 mg/Kg lidocaine normal saline in a volume of 3 ml/Kg 5 mcg/ml adrenaline. We will administrate 5 ml lidocaine at each port site before incision, then immediately after the 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 over the parietal peritoneum. The Trendelenburg position will be maintained for 2 minutes. Then 50 ml will be infiltrated in the bladder bed and pedicle after clamping of the cystic duct and artery. Infiltration will be through a laparoscopic suction needle, diameter 0.9 /330 mm (Zhejiang, China).
  • Placebo Comparator: the control group
    the same technique but the 50 ml for gallbladder infiltration will be replaced by saline.
 
Recruiting
88
与当前相同
September 1, 2019
September 1, 2019   (主要结果测量的最终数据收集日期)
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.
参与研究的性别: All
最小年龄:20 Years ,最大年龄:60 Years  
没有
Egypt
 
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
计划分享 IPD:
Alaa Mazy,Mansoura University
Alaa Mazy
Study Director: alaa mazy, MD faculty of medicine, Mansoura
Mansoura University
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
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