The Effect of Gallbladder Bed Infiltration on Analgesia in Laparoscopic Cholecystectomy
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 发起方
- 入组人数
- 70
- 试验地点
- 1
- 主要终点
- The total postoperative analgesic consumption
研究概览
简要总结
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.
详细描述
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.
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Parallel
- 主要目的
- Prevention
- 盲法
- Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
盲法说明
the infiltration cocktail of local anesthetic will be replaced by saline in the same volume.
入排标准
- 年龄范围
- 20 Years 至 60 Years（Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Scheduled to undergo elective laparoscopic cholecystectomy.
- •American Society of Anesthesiologists physical status (ASA) I or II.
排除标准
- •Patient in receipt of analgesics or sedatives 24 h before scheduled surgery.
- •Patient with spillage or cholelithiasis with known common bile duct pathology.
- •Body Mass Index > 40 Kg/m
- •Patient underlying severe systemic disease.
- •Patient with a history of abdominal surgery, a chronic pain disorder other than gallbladder disease or allergy to lidocaine.
研究组 & 干预措施
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).
干预措施: the infiltration group (Drug)
the control group
the same technique but the 50 ml for gallbladder infiltration will be replaced by saline.
干预措施: the control group (Drug)
结局指标
主要结局
The total postoperative analgesic consumption
时间窗: postoperative, for 24 hours
ketorolac and morphine in mg .
次要结局
- The intraoperative fentanyl requirements.(intraoperative)
- postoperative pain score: VAS(postoperative at 0, 2, 4, 8, 12, 16 and 24 hours)
- heart rate(basal and intraoperatively every 30 minutes, then at 0, 2, 4, 8, 12, 16 and 24 hours post-operatively.)
- mean blood pressure(basal and intraoperatively every 30 minutes, then at 0, 2, 4, 8, 12, 16 and 24 hours post-operatively.)
- incidence of vomiting(postoperatively, during the first 24 hours)
- The time to the first request of analgesia(postoperative, for 24 hours)
- Patient satisfaction regards analgesia:(postoperative after 24 hour.)
- the sleep quality(postoperatively, after the first night.)
- Surgeon satisfaction regards the technique:(postoperative within 1 hour.)
研究者
Alaa Mazy Mazy
associate prosseor
Mansoura University