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临床试验/NCT06253208
NCT06253208招募中不适用

Postoperative Analgesia in Laparoscopic Sleeve Gastrectomies: Laparoscopic Versus Ultrasound-guided Transversus Abdominis Plane Block

Biruni University1 个研究点 分布在 1 个国家目标入组 50 人开始时间: 2024年1月1日最近更新:
适应症

试验速览

阶段
不适用
状态
招募中
发起方
入组人数
50
试验地点
1
主要终点
postoperative pain

研究概览

简要总结

Comparison of pain conditions in the first 24 hours after surgery in terms of two different analgesia methods

详细描述

Introduction and purpose:

Morbid obesity (MO) is a disease that has become a worldwide epidemic, and in the last three decades, the average body mass index (BMI) has increased by 0.4 kg/m2 per decade worldwide. Parallel to this situation, the number of obesity surgery operations is increasing steadily. In 2017, this number reached 228,000 surgeries in the United States. In particular, due to its technical simplicity and positive outcomes, laparoscopic sleeve gastrectomy (LSG) has become the dominant bariatric operation, accounting for approximately 60% of all bariatric procedures (1) These individuals are at high risk for postoperative adverse respiratory events, nosocomial infections, cardiovascular complications, and pulmonary embolism (the second leading cause of death in the bariatric surgery population). Therefore, given the increasing number of patients living with obesity and seeking elective weight loss surgery, it is crucial to understand and optimize the analgesic requirements of this patient population. However, no ideal analgesic regimen exists for this patient population and limited evidence-based recommendations (2) Pain management of the MO patient is an evolving issue and remains extremely important in terms of patient safety and possible addiction risk. Effective postoperative pain management is crucial to encouraging early walking and deep breathing, which are known to reduce the risk of complications. Multimodal analgesia has been advocated by many authors as part of Enhanced Recovery After Surgery (ERAS) programs to reduce the incidence and severity of postoperative pain (3).

Similar to the increase in the number of MOs over the past three decades, opioid use has also increased dramatically. In the United States, opioid overdose has become the leading cause of unintentional death, surpassing motor vehicle crashes. Frequently, the first exposure to opioids may occur during the perioperative period of an elective surgery. It has been reported that approximately 6-8% of opioid-naïve patients undergoing non-cancer procedures develop new persistent opioid use (1). Increased opiate use is associated with increased rates of delirium, ileus, urinary retention, and respiratory depression and may have strong addictive potential. Opioid-induced cardiopulmonary arrest usually occurs within the first 24 hours of surgery (3). Therefore, the surgical team has a critical role in patient management in terms of opioid-independent analgesia control.

To optimize pain control, multimodal anesthesia and regional analgesia have become key components of improved clinical recovery pathways and therefore recommended methods for perioperative pain control. One of these is the transversus abdominis plane (TAP) block, whose effectiveness has been proven in this patient group.

TAP blocks are widely used for intraoperative and postoperative analgesia in various abdominal and gynecological surgeries. There is evidence in the literature that TAP blocks are beneficial in laparoscopic (minimally invasive) surgeries such as laparoscopic cholecystectomy, hernia repair and laparoscopic colorectal resection (4-8). Similarly, in two of the studies demonstrating the feasibility of TAP blocks in laparoscopic bariatric surgery (9,10), it was shown that there was a decrease in pain scores and in another (9) it was shown that it reduced opioid consumption.

研究设计

研究类型
Observational
观察模型
Case Crossover
时间视角
Prospective

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

  • Patients who can tolerate general anesthesia and pneumoperitoneum.
  • Patients who can give informed consent for surgery.
  • Patients over 18 years of age
  • patients with body mass index (BMI) > 30 kg/m2
  • Patients with American Society of Anesthesiologists (ASA) physical status I and II

排除标准

  • Patients allergic to local anesthetics.
  • Patients with serious underlying cardiovascular disease (e.g. congestive heart failure, conduction disorders and ischemic heart disease).
  • Patients with chronic kidney disease stage 3 or greater (creatinine clearance less than 60 mL/min).
  • Patients who have had previous abdominal surgery, including resection of the esophagus, stomach, liver and pancreas.
  • Patients with chronic pain and chronic opioid use
  • Patients with ASA class IV
  • patients with psychiatric disorders
  • pregnant or breastfeeding patients
  • patients with a history of seizures

结局指标

主要结局

postoperative pain

时间窗: 4 month

postoperative pain

次要结局

未报告次要终点

研究者

发起方
Biruni University
申办方类型
Other
责任方
Principal Investigator
主要研究者

ilke dolğun

anesthesia and reanimation

Biruni University

研究点 (1)

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