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临床试验/NCT04039321
NCT04039321已完成不适用

The Effect of Erector Spina Plane Block on Pulmonary Functions and Analgesic Consumption in Laparoscopic Sleeve Gastrectomy Surgery

Antalya Training and Research Hospital1 个研究点 分布在 1 个国家目标入组 40 人开始时间: 2019年8月1日最近更新:
适应症
干预措施
相关药物

试验速览

阶段
不适用
状态
已完成
发起方
入组人数
40
试验地点
1
主要终点
pulmonary function test

研究概览

简要总结

The aim of the study is to evaluate the effect of erector spina plane (ESP) block on pulmonary functions and postoperative analgesic consumption in patients undergoing bariatric surgery.

详细描述

Optimal pain management is very important in obese patients. In the postoperative period, narcotic analgesics are often used to pain management. However, the use of narcotic analgesics in the postoperative period causes many undesirable adverse effects, especially sedation, dizziness, constipation, nausea, vomiting, muscle rigidity, tolerance, and respiratory depression.

The morbidly obese patients treated with narcotic analgesics increased risk for adverse effects such as atelectasis, hypoxemia, and postoperative ileus. Consequently, these are caused postoperative pulmonary complications, hypoxemia and longer lenght of hospital stay. Multimodal analgesia including local and regional anesthesia is recommended for morbidly obese patients.

In recent years, the ultrasound (USG) guided ESP block has been frequently used to eliminate postoperative pain and reduce narcotic analgesic use. In the literature, it has been shown that bilateral USG guided ESP block provides effective analgesia and decrease the analgesia requirements after laparoscopic cholecystectomy. Some case series and case reports has also been reported that ESP block provides effective analgesia after abdominal and bariatric surgeries.

The aim of the study is to evaluate the effect of erector spina plane (ESP) block on pulmonary functions and postoperative analgesic consumption in patients undergoing bariatric surgery. For this purpose, ASA II-III, patients over 18 years of age, BMI 40-60 kg/m2 and elective bariatric surgery planned patients will be included in the study.

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
Single (Care Provider)

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

  • American Society of Anesthesiology (ASA) II-III
  • 18-65 years
  • body mass index (BMI) 40-60 kg/m2
  • elective bariatric surgery

排除标准

  • under 18 years of age or over 65 years of age
  • declining to give written informed consent
  • have neurological and/or psychiatric disorders
  • cooperation cannot be established
  • accompanying laparoscopic cholecystectomy or paraumbilical hernia repair
  • history of bariatric surgery
  • the block cannot be applied due to bleeding disorders or localized skin infection at the injection site
  • with hepatic, neuromuscular, cardiac and/or renal failure
  • history of allergy to the local anesthetics
  • patients undergoing open surgery
  • patients with severe obstructive or restrictive lung disease

研究组 & 干预措施

ESPB group

Active Comparator

Before anaesthesia induction; bilateral ESP block will be performed under the guidance of USG. Patients will be administered paracetamol 1 gr IV every 8 hours in the postoperative period. If patients' NRS score will ≥4/10, 100 mg IV tramadol will be performed.

干预措施: ESPB group (Drug)

Control group

Sham Comparator

Patients will be administered paracetamol 1 gr IV every 8 hours in the postoperative period. If patients' NRS score will ≥4/10, 100 mg IV tramadol will be performed.

干预措施: Control group (Drug)

结局指标

主要结局

pulmonary function test

时间窗: perioperative

Pulmonary function test will be performed for all of them in the day before operation and 24 hours after the operation. Pulmonary function tests will assess via a portable spirometer with the patient in the sitting or semi-recumbent position.

analgesia consumption

时间窗: 24 hours

postoperative 24 hours

次要结局

  • arterial blood gases(during the surgery)
  • Postoperative Numeric Rating Scale (NRS) score(postoperative 0, 1, 3, 6, 9, 12, 18, 24 hours)

研究者

发起方
Antalya Training and Research Hospital
申办方类型
Other Gov
责任方
Principal Investigator
主要研究者

Arzu Karaveli

study director

Antalya Training and Research Hospital

研究点 (1)

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