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临床试验/NCT04915521
NCT04915521已完成不适用

Effect of Ultrasound-guided Erector Spinalis Plane Block on Postoperative Pain and Intraoperative Opioid Consumption in Bariatric Surgery

Meliha Orhon2 个研究点 分布在 1 个国家目标入组 62 人开始时间: 2020年1月10日最近更新:
适应症

试验速览

阶段
不适用
状态
已完成
发起方
入组人数
62
试验地点
2
主要终点
total intraoperative opioid consumption,

研究概览

简要总结

Background/objective: Bariatric surgery is often associated with moderate to severe pain. In obese individuals, opioids have the potential to induce ventilatory impairment; thus, opioid use needs to be limited. This study aimed to compare the novel ultrasound-guided erector spinalis plane block (ESPB) technique with controls in terms of intraoperative opioid consumption and postoperative pain control. Methods: A total of 63 patients with morbid obesity who underwent laparoscopic bariatric surgery were included in this randomized study. Patients were randomly assigned to the bilateral erector spina plane block (ESPB) group or the control group. To evaluate perioperative pain and to adjust opioid dose, analgesia nociception index (ANI) was monitored during surgery. Total opioid dose was recorded for each patient. In addition, pain was evaluated using visual analogue scale (VAS) scores for 24 hours following the operation.

详细描述

Obesity represents a major disease burden and healthcare challenge globally due to its increasing prevalence over the last decades. From 1980 to 2013, worldwide prevalence of overweight/obesity increased by 27·5% for adults and 47·1% for children, resulting in an estimated global total number of obese/overweight individuals slightly more than two billion. Obesity is associated with serious conditions including cardiovascular disease, diabetes, some cancers, kidney disease, sleep apnea, gout, osteoarthritis, hepatobiliary disease, resulting in increased mortality and decreased life expectancy among obese individuals. On the other hand, weight loss leads to improvement of these conditions and outcomes. Life-style modifications with diet, exercise, and behavioral therapy, pharmacotherapy, and surgery are used for the management of obesity. Bariatric surgery represents an effective and a sustainable treatment modality in patients with morbid obesity, laparoscopic sleeve gastrectomy and gastric bypass being the most common procedures. However, these procedures are mostly associated with moderate to severe postoperative pain, which is often a combination of abdominal wall pain and visceral pain.Postoperative pain, when not adequately controlled, has unfavorable consequences such as impaired quality of life and recovery as well as increased risk of surgical complications and persistent postsurgical pain. Patients with morbid obesity represent a special group when it comes to perioperative pain management. These patients have a higher incidence of sleep-disordered breathing; therefore, opioids have the potential to induce ventilatory impairment resulting in increased morbidity/mortality. Stepwise and severity based-multi-modal analgesia with opioid-sparing approach can improve safety; thus, Enhanced Recovery After Surgery (ERAS) guidelines for bariatric surgery currently recommend opioid reduction in bariatric surgery. Both systemic analgesics and regional approaches such as transversus abdominis plane (TAP) block, intraperitoneal and wound modalities, and neuraxial techniques are being used for postoperative pain control in bariatric surgery with some success.

Ultrasound-guided erector spinae plane block is a novel regional anesthesia technique where local anesthetic agent is injected deep into the erector spinae muscle to the fascial plane and allowed to diffuse in caudal and cranial direction. It has been shown effective in a number of conditions such as thoracic surgery/trauma, painful conditions of the limbs, cardiac surgery, breast surgery, and abdominal surgery. To date, only few studies examined the use of ESPB in bariatric surgery, all indicating potential benefits of the technique in terms of opioid sparing and pain control.

This study aimed to compare bilateral ultrasound-guided erector spinalis plane block technique with controls who received bupivacaine injection to the trocar sites, in terms of intraoperative opioid consumption, postoperative pain control in the first 24 hours, and need for rescue analgesic.

METHODS

Patients Sixty-two patients with morbid obesity who underwent laparoscopic bariatric/metabolic surgery (sleeve gastrectomy or gastric bypass) were included in this randomized study.

研究设计

研究类型
Interventional
分配方式
Non Randomized
干预模型
Crossover
主要目的
Prevention
盲法
Single (Participant)

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 were required to have a BMI ≥40 kg/m
  • ASA physical status class 2 or 3.

排除标准

  • any complication (allergic reaction or local anesthesia-related complication)
  • failure, or patient refusal during the block procedure
  • switch to open surgery or a change in the planned surgical protocol
  • analgesia nociception index (ANI) and/or bispectral index (BIS) monitoring not possible
  • patient does not provide consent or withdraws consent at any point after inclusion.

结局指标

主要结局

total intraoperative opioid consumption,

时间窗: postoperatif first 24 hours

To evaluate intraoperatif opioid consumption, ANI was continuously monitored throughout the surgical procedure.

次要结局

  • measure vas the change in postoperative pain(up to 6, 12, and 24 hours.)

研究者

发起方
Meliha Orhon
申办方类型
Other
责任方
Sponsor Investigator
主要研究者

Meliha Orhon

assistant professor

Marmara University

研究点 (2)

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