跳至主要内容
临床试验/NCT07626463
NCT07626463招募中不适用

The Efficacy and Safety of Pre-incisional Infiltration With Ropivacaine Plus Diprospan in Patients Undergoing Laparoscopic Surgery: a Multi-center Randomized Controlled Trial.

Beijing Tiantan Hospital1 个研究点 分布在 1 个国家目标入组 150 人开始时间: 2026年5月30日最近更新:
干预措施

试验速览

阶段
不适用
状态
招募中
发起方
入组人数
150
试验地点
1

研究概览

简要总结

Incisional infiltration is the simplest, safest, and most effective anesthesia method for preventing incision pain after laparoscopic surgery, but even using long-acting local anesthetics, the effectiveness of postoperative analgesia can only last for a relatively short period of time. Studies have shown that up to 80% of patients experience postoperative pain following laparoscopic surgery due to inflammation caused by surgical incisions and surrounding tissues, necessitating pharmacological relief. Inflammatory mediators released from the soft tissues around laparoscopic incisions not only significantly alters the chemical microenvironment at the peripheral terminals of nociceptors, directly inducing pain, but also sensitizes afferent fibers, contributing to peripheral sensitization.

Numerous studies have shown that glucocorticoids not only can achieve anti-inflammatory and analgesic effects by inhibiting inflammatory cytokines and inflammatory responses but also can prolong the duration of action of local anesthetics. Preemptive incisional infiltration using local anesthetics with corticosteroids which have potent local anti-inflammatory properties may play a key role in preventing or reducing postoperative pain. The objective of this trial is to determine whether preemptive incisional infiltration with ropivacaine plus diprospan is superior to ropivacaine alone in relieving postoperative pain for adults undergoing laparoscopic surgery. The investigators also compare the effects of the two intervention measures on postoperative pain management, patient safety, and 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
Prevention
盲法
Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)

入排标准

年龄范围
18 Years 至 64 Years(Adult)
性别
All
接受健康志愿者

入选标准

  • Patients scheduled for elective Laparoscopic Surgery for laparoscopic cholecystectomy, appendectomy, or hernia repair under general anesthesia;
  • Ages 18 to 64 years old;
  • American Society of Anesthesiologists (ASA) physical status of I-III;
  • Patients must be able to understand nature and potential personal; consequences of the clinical trial and cooperation with follow-up investigations;
  • signing of the informed consent form.

排除标准

  • History of allergies to experimental drugs such as opioids or steroids;
  • Alcohol abuse; Long term use of opioid drugs (exceeding 2 weeks or 3 days per week for more than 1 month); Suspected use of sedatives and analgesics;
  • Use analgesic drugs within 24 hours before surgery;
  • Patients undergoing steroid therapy;
  • Serious neurological disorders, severe liver and kidney dysfunction, heart failure, etc;
  • Unable to use pain assessment scale;
  • Pregnant or lactating patients.

研究组 & 干预措施

Pre-incisional infiltration with ropivacaine plus diprospan

Experimental

干预措施: Pre-incisional infiltration with ropivacaine and diprospan (Drug)

Pre-incisional infiltration with ropivacaine alone

Active Comparator

干预措施: Pre-incisional infiltration with ropivacaine alone (Drug)

研究者

发起方
Beijing Tiantan Hospital
申办方类型
Other
责任方
Principal Investigator
主要研究者

Fang Luo

Director, Department of Day Surgery, Principal

Beijing Tiantan Hospital

研究点 (1)

Loading locations...

相似试验