Therapeutic Efficacy of Intravenous Lidocaine Infusion Compared With Epidural Analgesia for Postoperative Pain Control in Adult Patients Undergoing Major Abdominal Surgery: Non-Inferiority Clinical Trial
试验速览
- 阶段
- 4 期
- 状态
- 已完成
- 入组人数
- 210
- 试验地点
- 1
- 主要终点
- Posoperative Pain
研究概览
简要总结
Major abdominal surgery continues is one of the most performed surgical procedures in the world, both electively and urgently. One of the main problems of this type of intervention is postoperative pain. it is shown that it increases health costs related to longer recovery times, longer hospital stay and related complications such as the increased risk of presenting chronic POP pain, which it has been estimated up to 20%, much higher if the surgery involves surgery in the gastrointestinal system.
The goal of analgesia in the postoperative setting is precisely to provide comfort to patients, minimize adverse effects and complications arising from the procedure.
The epidural analgesic technique (has been proposed as an analgesic management standard, since multiple studies have shown that it reduces opioid consumption, improves recovery and is a useful strategy for pain control. However, it is an invasive technique, with risk of complications such as hematomas and epidural abscesses, and it may be difficult to perform.
Currently it has been shown in multiple studies that the intravenous infusion of a local anesthetic, such as lidocaine, in this type of surgical scenarios can reduce the intensity of pain, opioid consumption, hospital stay and ileus with few adverse effects. In addition, these studies propose that, being a less invasive technique, it could be easier to implement and even be safer than the epidural technique.
The main hypothesis of this study is precisely that the infusion of lidocaine may be non-inferior to epidural analgesia in the analgesic management of patients undergoing major abdominal 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
- Triple (Participant, Investigator, Outcomes Assessor)
盲法说明
The masking process will be done as follows:
Masking of the data collection and analysis staff: The investigative staff who performs the data collection and who evaluates the outcomes after the anesthetic act, will not have information about the intervention received by the patient. Those who participate in the data analysis phase will also be blind to the intervention.
For practical and ethical point of view, it is not possible to mask the doctors who perform the intervention and neither the patients. A "SHAM" or simulated intervention is not possible given that this would require an unnecessary invasive procedure that would not be used, which would make it ethically questionable.
入排标准
- 年龄范围
- 18 Years 至 —（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 是
入选标准
- •Patient over 18 years.
- •Elective major open intra-abdominal surgery:
- •Cholecystectomy.
- •Total or subtotal gastrectomy.
- •Colectomy or Hemicolectomy.
- •Pancreatoduodenectomy.
- •Hepatectomy 1 or 2 segments.
- •Exploration and / or reconstruction of the bile duct.
- •Abdominal demolition.
- •Sigmoidectomy.
- •Patient classified as ASA (American Association of Anesthesiology) 1, 2 or 3.
排除标准
- •Pregnant woman
- •Patient with contraindication for epidural analgesic techniques:
- •Anticoagulated patient
- •Active infection in the puncture site.
- •Malformation in spinal cord.
- •Sepsis without antibiotic treatment.
- •Patient with contraindication for the use of intravenous lidocaine: Arrhythmias of any type not treated.
- •Patient with known allergy to opioids and / or local anesthetics.
- •Patient with chronic pain in previous management with strong opioids, gabapentinoids or epidural technique.
- •Patient with liver failure or terminal renal failure.
- •Patient who is scheduled for intubated admission to an intensive care unit after the procedure.
- •Patient who refuses to participate in the study or who refuses to receive epidural analgesia.
- •Patient who was technically impossible to place an epidural catheter in surgery.
研究组 & 干预措施
Epidural Analgesia
The placement of the thoracic epidural catheter will be located depending on surgical incision as follows:
- Surgery of the upper abdomen: T7-T8.
- Surgery of lower abdomen: T8-T9. The epidural catheter placement technique will be determined by the treating anesthesiologist. However, once the epidural space is located and the respective catheter is inserted, the correct location of the catheter should be tested with lidocaine at 2% CE 5 cc and a sensitivity test with temperature should be performed on the target dermatomes. A negative test for an adequate location of the catheter indicates that the procedure should be repeated until the epidural space is correctly located. Once this is achieved, the catheter will be left 4 cm away from the skin. The catheter will be fixed according to the institutional protocol.
干预措施: Epidural Analgesia (Procedure)
Lidocaine Infussion
Intravenous lidocaine
干预措施: Lidocaine Infusion (Drug)
结局指标
主要结局
Posoperative Pain
时间窗: 24 hours after surgery
Numerical Rating Scale (NRS) for pain. The NRS for pain is a unidimensional measure of pain intensity in adults.The pain NRS is a single 11-point numeric scale. An 11-point numeric scale (NRS 11) with 0 representing one pain extreme (e.g., "no pain") and 10 representing the other pain extreme (e.g., "pain as bad as you can imagine" and "worst pain imaginable").
次要结局
- Posoperative opioid use(24 hours after surgery)
- Posoperative Pain(2, 6, 12, 48 and 72 hours after surgery)
- Hospital Stay(From date of randomization until the date day of discharge or date of death from any cause, whichever came first, assessed up to 100 months)
- Perioperative Satisfaction(24 hours)
- Toxicity by local anesthetics proportion(24 hours after surgery)
- Posoperative nausea and vomiting(24 hours after surgey)