Optimal Postoperative Pain Management by Ultrasound-guided Abdominal Wall Nerve Blockade in Laparoscopic Surgery for Acute Appendicitis - a Randomised Controlled Trial.
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 入组人数
- 56
- 试验地点
- 1
- 主要终点
- Area under the curve (AUC), 0-12 hours, numerical rating score-pain-(NRS)0-10
研究概览
简要总结
Acute appendicitis is a common disease and usually occurs within the ages of 10-30 years old." Ten percent of the population will get this disease during a lifetime." At Bispebjerg hospital it is one of the most common acute surgeries performed. Though at Bispebjerg hospital the surgery is only performed on adults as there is no pediatric ward. The surgical technique is primarily laparoscopic surgery, where the patients have their appendix removed while in general anaesthesia. During the last three years Bispebjerg hospital has had an average of 287 patients per year undergoing laparoscopic surgery. From January to the September 2012 a total of 211 patients have had the operation, with 29% having the operation performed during daytime, 48% in the evening and 22% at night. Open appendectomy is only performed in cases where laparoscopic surgery is impossible, this is often due to adhesions, scar tissue from former abdominal surgery or peritonitis. The scars from laparoscopic surgery are usually smaller than that from an open appendectomy, but it gives the patient three smaller scars divided on three abdominal quadrants instead of one larger scar on one quadrant.
The investigators want to conduct a clinical trial with fifty six patients undergoing laparoscopic surgery due to acute appendicitis. The investigators want to find out if it is possible to improve the post-operative pain management within this very large group of patients undergoing acute surgery. In detail, the investigators wish to explore whether the use of the BD-TAP blockade in the abdominal wall on patients undergoing laparoscopic surgery due to acute appendicitis, can anesthetize the patients completely or partially, so they can avoid morphine intake completely or partially during the post-operative phase (12-24 hours). The research project will be a randomized, double-blinded, controlled clinical trial.
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
- Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
入排标准
- 年龄范围
- 18 Years 至 —（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Age above 18 years
- •Patients undergoing diagnostic laparoscopy for acute appendicitis
- •American Society of Anaesthesiology group 1-3
- •General Anaesthesia
排除标准
- •Inability to cooperate
- •Inability to understand and talk danish
- •Allergic to ropivacaine
- •Drug and alcohol abuse
- •Pregnancy or nursing
研究组 & 干预措施
Active abdominal wall block
60ml ropivacaine 0.375% single shot
干预措施: Ropivacaine (Drug)
Placebo abdominal wall block
60ml saline 9% single shot
干预措施: Saline 9% (Drug)
结局指标
主要结局
Area under the curve (AUC), 0-12 hours, numerical rating score-pain-(NRS)0-10
时间窗: 0-12 hours postoperatively
Pain score (NRS) assessed when sitting up 0-12 hours postoperatively. AUC is calculated over a time frame of 0-12 hours.
次要结局
- Area under the curve (AUC), 0-12 hours postoperatively, numerical rating score - pain-(NRS) 0-10(0-12 hours postoperatively)
- Morphine consumption postoperatively(0-12 hours postoperatively)
- Length of stay (LOS) in the postanesthesia care unit (PACU)(Time from arrival in PACU to time of departure (measured in minutes))
- Side effects related to morphine consumption(0-12 hours postoperatively)
- Time to first mobilisation 0-12 hours postoperatively(0-12 hours postoperatively)
研究者
Jens Borglum Neimann
Associate professor, consultant anesthetist, PhD
Bispebjerg Hospital