The Efficacy and Safety of Pre-incisional Infiltration With Ropivacaine Plus Diprospan in Patients Undergoing Laparoscopic Surgery: a Multi-center Randomized Controlled Trial.
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
- 否
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
干预措施: Pre-incisional infiltration with ropivacaine and diprospan (Drug)
Pre-incisional infiltration with ropivacaine alone
干预措施: Pre-incisional infiltration with ropivacaine alone (Drug)
研究者
Fang Luo
Director, Department of Day Surgery, Principal
Beijing Tiantan Hospital
