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临床试验/NCT06145945
NCT06145945尚未招募不适用

A Randomized Controlled Study of the Effect of Intraperitoneal Ropivacaine on Visceral Pain After Laparoscopic Gastrectomy

SanQing Jin1 个研究点 分布在 1 个国家目标入组 72 人开始时间: 2023年11月25日最近更新:
适应症
干预措施
相关药物

试验速览

阶段
不适用
状态
尚未招募
发起方
入组人数
72
试验地点
1
主要终点
NRS scores of visceral pain

研究概览

简要总结

Visceral pain is obvious and lasts for a long time in patients after laparoscopic gastrectomy.Relieving the visceral pain is of great significance for patients' postoperative emotional experience, functional recovery and reducing the formation of long-term chronic pain. However, there is no clear clinical consensus on relieving visceral pain by now, so effective clinical methods to relieve visceral pain need to be explored urgently.

Intraperitoneal spraying local anesthetics is a simple and inexpensive method, which has been proved to be safe and effective in randomized controlled trials and Meta-analysis of various types of surgery.However, its effect in clinical research is still controversial and many studies lack evaluation of postoperative recovery quality, so it has not been widely used in clinical practice.

This study aims to explore the effect of intraperitoneal spraying ropivacaine (long-acting amide local anesthetic) on visceral pain after laparoscopic gastrectomy, and to systematically evaluate its effect on the recovery of gastrointestinal function and the inflammatory factors (IL-6, TNF-α) in abdominal drainage fluid.

详细描述

Postoperative pain is a common adverse reaction after laparoscopic gastrectomy. Insufficient analgesia can cause severe stress response,affect the recovery of postoperative gastrointestinal function, increase the incidence of postoperative complications and prolong the length of hospital stay. Although laparoscopic surgery significantly reduces postoperative pain compared to traditional open surgery, the management of postoperative pain remains a challenge. Postoperative pain after laparoscopic surgery is mainly divided into three parts: incision pain(somatic pain component), deep abdominal pain (visceral pain component) and shoulder pain (referred pain component). In a prospective study, Blichfeldt-Eckhardt et al. found that visceral pain accumulated in the first week after surgery was identified as an independent risk factor for unexplained chronic pain at 12 months after surgery, and visceral pain was the only pain component that was independently and significantly associated with chronic unexplained pain at 12 months after surgery .

Visceral pain is generally defined as pain caused inside the body, but is usually caused by excessive contraction, stretching, or ischemia of the walls of internal organs . In contrast to pain signals originating from the skin,pain originating from the viscera is described as dull and diffuse, often poorly localized, and can be distant from its origin.Visceral pain is considered more unpleasant and frightening than somatic pain.

Therefore,relieving the visceral pain is of great significance for patients' postoperative emotional experience, functional recovery and reducing the formation of long-term chronic pain. However, there is no clear clinical consensus on relieving visceral pain by now, so effective clinical methods to relieve visceral pain need to be explored urgently.

Intraperitoneal spraying local anesthetics is a simple and inexpensive method, which has been proved to be a safe and effective way to reduce the use of opioid and postoperative pain score in randomized controlled trials and Meta-analysis of various surgical types such as laparoscopic cholecystectomy , laparoscopic appendectomy , laparoscopic gynecology and so on. Intraperitoneal spraying local anesthetics is a type of topical anesthesia.Local anesthetics produce local anesthesia by acting on nerve endings on the surface of the visceral organs.Visceral organs mainly transmit nociceptive signals through the vagus nerve and spinal nerve, among which the spinal nerve mainly transmits mechanical stimulation signals, while the vagus nerve mainly transmits chemical stimulation signals. Arman Kahokehr et al. found that intraperitoneal spraying local anesthetics during colectomy may reduce postoperative pain by blocking intra-abdominal vagus nerve signals. At the same time, it inhibits the corresponding neuroendocrine stress pathway, thus resulting in behavioral benefits. However, it does not separately evaluate the different pain components of patients after surgery.

At the same time,the effect of intraperitoneal spraying local anesthetics is still controversial and many studies lack evaluation of postoperative recovery quality,so this technique has not been widely used in clinical practice. Schipper IE et al. spray 20ml 2.5% bupivacaine into the abdominal cavity during laparoscopic gastric bypass surgery, and the test results indicated that the experimental group did not significantly reduce postoperative pain or opioid use, and the use of antiemetic drugs and the length of hospital stay were not significantly reduced.A review in 2021 included 85 clinical trials of intraperitoneal spraying local anesthetics during laparoscopic cholecystectomy, found that intraperitoneal spraying local anesthetics could reduce pain for up to 24 hours in patients undergoing laparoscopic cholecystectomy. However,none of these trials provided postoperation follow-up information and evaluation of postoperative recovery quality.

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
Triple (Participant, Investigator, Outcomes Assessor)

入排标准

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

入选标准

  • Age 18-65 years old
  • The American Society of Anesthesiologists(ASA) grade is I or II, and the heart function grade is 1-2;
  • Elective laparoscopic gastrectomy under general anesthesia

排除标准

  • Patients have severe heart, lung, liver, and kidney diseases (heart function grade>3 / respiratory failure / liver failure / renal failure)
  • BMI<18kg/m2 or >30kg/m2
  • Patients with chronic pain other than stomach pain and taking analgesics for a long time
  • Patients with history of allergy to local anesthetics
  • Patients with high risk of reflux and aspiration such as digestive obstruction
  • Patients who refuse to participate or don't sign or refuse to sign the informed consent form
  • Patients who are unable to communicate effectively
  • Patients participate in other clinical trials

研究组 & 干预措施

Ropivacaine

Experimental

20ml 0.5% ropivacaine is sprayed intraperitoneally

干预措施: 0.5% Ropivacaine (Drug)

Saline

Placebo Comparator

20ml saline is sprayed intraperitoneally

干预措施: Saline (Drug)

结局指标

主要结局

NRS scores of visceral pain

时间窗: 24 hours after surgery

NRS scores of visceral pain at 24 hours after surgery

次要结局

  • NRS scores of referred pain(From surgery completion to the 30th day after surgery)
  • Blood pressure(SBP,DBP,MAP)(From the period of anesthesia to the third day after surgery)
  • Additional analgesics in the ward(From surgery completion to the third day after surgery)
  • Interleukin-6(IL-6)(24 hours after surgery)
  • First drinking time after surgery(From surgery completion to first drinking after surgery,assessed up to 7 days)
  • First eating time after surgery(From surgery completion to first eating after surgery,assessed up to 7 days)
  • Removal of stomach tube time(From surgery completion to removal of stomach tube,assessed up to 30 days)
  • Removal of drainage tube time(From surgery completion to removal of drainage tube,assessed up to 30 days)
  • Incidence of postoperative complications within 30 days after surgery(Within 30 days after surgery)
  • Oxygen saturation(From the period of anesthesia to the third day after surgery)
  • Nausea and vomiting(From surgery completion to the third day after surgery)
  • Use of intravenous analgesia pump(From surgery completion to the third day after surgery)
  • Postoperative recovery score using 15-item quality of recovery scoring system(QoR-15)(From the first day to the 30th day after surgery)
  • Anal exhaust time(From surgery completion to first anal exhaust after surgery,assessed up to 7 days)
  • NRS scores of visceral pain(From surgery completion to the 30th day after surgery)
  • NRS scores of incisional pain(From surgery completion to the 30th day after surgery)
  • Serum C-reactive protein (CRP) concentration(One day before surgery and 24 hours after surgery)
  • Getting out of bed time(From surgery completion to first getting out of bed after surgery,assessed up to 7 days)
  • Tumor necrosis factor-α(TNF-α)(24 hours after surgery)
  • Heart rate(From the period of anesthesia to the third day after surgery)
  • The level of blood glucose(One day before surgery and 24 hours after surgery)
  • Sitting up time(From surgery completion to first sitting up after surgery,assessed up to 7 days)
  • Length of hospital stay after surgery(From surgery completion to actual hospital discharge, assessed up to 30 days)
  • Removal of indwelling urinary catheter time(From surgery completion to removal of indwelling urinary catheter,assessed up to 30 days)

研究者

发起方
SanQing Jin
申办方类型
Other
责任方
Sponsor Investigator
主要研究者

SanQing Jin

professor

Sixth Affiliated Hospital, Sun Yat-sen University

研究点 (1)

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