跳至主要内容
临床试验/NCT03481517
NCT03481517已完成4 期

The Interest of Wound Infiltration With Local Anesthetic Agent for Laparoscopic Appendectomy in Adult: a Double Blind, Prospective, Randomized Control Trial

National Taiwan University Hospital1 个研究点 分布在 1 个国家目标入组 47 人开始时间: 2018年4月23日最近更新:
适应症
干预措施
相关药物

试验速览

阶段
4 期
状态
已完成
入组人数
47
试验地点
1
主要终点
Pain score of surgical wound of the patient

研究概览

简要总结

Acute appendicitis is one of the most common acute abdomens that need surgical intervention. Laparoscopic surgery much decreases postoperative pain of wound, however, pain remains an important determinant of recovery after surgery. Intraoperative local anesthetic agent infiltrated locally into surgical wound to relieve postoperative pain is a feasible and safe method suggested in some literature. However, there is no routine use of this method in clinical practice because its benefit is still unknown. Besides, very few evidence could be found in literature review. To date, there is still no double blinded, prospective, randomized control trial addressing in evaluation of its interest. In this study, the investigators aim at investigating the benefit of wound infiltration with local anesthetic agent (bupivacaine) for laparoscopic appendectomy in adult. The study design is a double blind, prospective, randomized control trial with a 1:1 allocation ratio. Fifty adult patients with appendicitis will be included. The control group undergo laparoscopic appendectomy without wound infiltration with local anesthetic agent, the intervention group undergo laparoscopic appendectomy with wound infiltration with local anesthetic agent intraoperatively. The clinical characteristics, outcomes, and patient's satisfaction will be recorded and analyzed. The investigators hope this study can provide a high level evidence in pain management of patient undergo laparoscopic 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, Investigator)

入排标准

年龄范围
20 Years 至 —(Adult, Older Adult)
性别
All
接受健康志愿者

入选标准

  • 未提供

排除标准

  • 未提供

研究组 & 干预措施

Wound with local anesthesia

Experimental

5 mL Bupivacaine is injected into subcutaneous area near surgical wound

干预措施: Bupivacaine (Drug)

结局指标

主要结局

Pain score of surgical wound of the patient

时间窗: within 24 hours after surgery

Using Visual Analog Score (from 0 to 10, 0 indicate no pain and 10 indicate maximal pain) to evaluate pain of surgical wound of the patient

次要结局

  • Satisfaction of the patient(up to one month after surgery)

研究者

申办方类型
Other
责任方
Sponsor

研究点 (1)

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