跳至主要内容
临床试验/NCT05676892
NCT05676892Unknown不适用

Effects of Intravenous Ibuprofen on Acute Pain After Laparoscopic Cholecystectomy; a Double-blind, Randomized, Placebo-controlled Trial

Seoul St. Mary's Hospital1 个研究点 分布在 1 个国家目标入组 140 人开始时间: 2023年3月1日最近更新:
适应症
干预措施

试验速览

阶段
不适用
入组人数
140
试验地点
1
主要终点
VAS (Visual Analogue Scale) score

研究概览

简要总结

This clinical trial is a medical intervention study to evaluate the necessity and effectiveness of intravenous ibupropan for postoperative acute pain relief after laparoscopic cholecystectomy in benign gallbladder disease. Comparison and evaluation of changes in pain scores after surgery according to the presence or absence of use.

详细描述

Cholecystectomy is the most common abdominal surgical procedure and is usually performed laparoscopically. Laparoscopic cholecystectomy is considered the standard surgery for gallstone disease, and this procedure has the advantages of less postoperative pain, better cosmetic results, shorter hospital stay, and faster wound healing than open cholecystectomy.

There are several factors that can cause pain after laparoscopic cholecystectomy, including stimulation of the phrenic nerve due to CO2 injection into the abdominal cavity, incision pain at the port site, and pain at the gallbladder removal site. Postoperative pain is an acute sensation that accompanies the surgical trauma and the observed inflammatory process and decreases as the tissue heals.

Postoperative analgesics are known to prevent pain-related effects in patients after surgery, such as increased cardiovascular system workload and increased stress response due to neuroendocrine and sympathetic nervous system activation. Like other NSAIDs, ibupropan is a propionic acid derivative that has anti-inflammatory, antipyretic and analgesic effects. The oral form has been used safely for a long time and is one of the most commonly used NSAIDs. Ibuprofan in the intravenous (IV) form has been used in the United States since 2009 for the treatment of mild to moderate and severe pain in combination with narcotic analgesics. Research on ibuprolan for intravenous injection is still insufficient, and there are very few studies showing its effect on pain relief after surgery. Therefore, this study was conducted in a double-blind, prospective, randomized, placebo-controlled clinical trial to investigate the evidence for clinical usefulness of the effect of intravenous ibupropan on postoperative pain in patients who underwent laparoscopic cholecystectomy.

Study population

  1. Inclusion criteria

研究设计

研究类型
Interventional
分配方式
Non Randomized
干预模型
Parallel
主要目的
Treatment
盲法
Triple (Participant, Care Provider, Investigator)

入排标准

年龄范围
19 Years 至 65 Years(Adult, Older Adult)
性别
All
接受健康志愿者
否

入选标准

  • •Patients who underwent elective gallbladder surgery (cholelithiasis, chronic cholecystitis, gallbladder polyps, gallbladder adenomyomatosis)
  • •Patients between the ages of 19 and 65 ③ A person who voluntarily signed a written consent form after hearing and understanding the explanation of this clinical trial

排除标准

  • •Patients with acute cholecystitis
  • •② Gallbladder cancer
  • •Cholecystitis with a gallbladder thickness of 4 mm or more on CT or ultrasound
  • •Cholecystitis with adhesions with surrounding organs due to inflammation of the gallbladder
  • •Pregnant or lactating women
  • •Those who undergo surgery at the same time due to other organ diseases ⑤ Those with immunosuppression and hemorrhagic tendencies
  • •Persons who have undergone preoperative percutaneous cholecystectomy (PTGBD)
  • •Persons who need drainage tube installation during surgery ⑧ Those who participated in other clinical trials within 3 months before screening ⑨ Persons judged by other investigators to be inappropriate to participate in this clinical trial

研究组 & 干预措施

The experimental group in benign gallbladder disease

Experimental

inclusion criteria

  • Patients who underwent elective gallbladder surgery (cholelithiasis, chronic cholecystitis, gallbladder polyps, gallbladder adenomyomatosis) ② Patients between the ages of 19 and 65 ③ A person who voluntarily signed a written consent form after hearing and understanding the explanation of this clinical trial

intravenous ibuprofen 800mg/8ml was used after surgery.

干预措施: Laparoscopic cholecystectomy (Procedure)

The controled group in benign gallbladder disease

Experimental

inclusion criteria

  • Patients who underwent elective gallbladder surgery (cholelithiasis, chronic cholecystitis, gallbladder polyps, gallbladder adenomyomatosis) ② Patients between the ages of 19 and 65 ③ A person who voluntarily signed a written consent form after hearing and understanding the explanation of this clinical trial

normal saline (Isotonic Sodium Chloride Injection Daihan(50mL/bag)) was used after surgery.

干预措施: Laparoscopic cholecystectomy (Procedure)

结局指标

主要结局

VAS (Visual Analogue Scale) score

时间窗: 7 days

Postoperative pain score in patients who underwent a laparoscopic cholecystectomy with the ibuprofen and normal saline. pain score : minimum 0 to maximum 10 (0:no pain - 10: worst pain)

次要结局

  • consumption of analgesics(Participants will be followed for the duration of hospital stay, an expected average of 2 days)

研究者

申办方类型
Other
责任方
Principal Investigator
主要研究者

Taeho Hong

Professor

Seoul St. Mary's Hospital

研究点 (1)

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