跳至主要内容
临床试验/NCT06377605
NCT06377605已完成不适用

The Efficacy of Thoracic Erector Spinae Plane Block For Perioperative Analgesia in Laparoscopic Bariatric Surgery for Super Obese Patients: Randomized Controlled Trial

Amany Ahmed Eissa1 个研究点 分布在 1 个国家目标入组 60 人开始时间: 2024年3月10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
60
试验地点
1
主要终点
Total opioid consumption

研究概览

简要总结

The epidemic of overweight and obesity presents a major challenge to chronic disease prevention and health across the life course around the world. [1] Bariatric surgery has proved to be an efficient intervention in the management of obesity. As a result, the number of post-bariatric surgery patients in the population is growing [2].

Postoperative analgesia presents various challenges in vulnerable patient groups suffering from obesity. With the high potential risk of respiratory depression and postoperative pulmonary complications associated with opioid use, such as atelectasis and pneumonia, the availability of other pain management modalities is essential [14].

Ultrasound-guided erector spinae plane block (ESPB) is a regional anesthesia technique where local anesthetic agent is injected deep to the erector spinae muscle to fascial plane and allowed to diffuse caudally and cranially. It is supposed to provide both visceral and somatic abdominal analgesia [3].

ESPB is effective, easy to perform, and can be performed in a short time. [4] It has been shown efficacy in different conditions such as thoracic surgery, trauma, cardiac surgery, breast surgery, and abdominal surgery [5]. However, the main concern with the ESPB block is feasibility together with the potency of the block in challenging populations, such as patients suffering from obesity.

Peripheral nerve blocks in the obese may pose challenges, like difficulties in proper patient positioning and landmark identification. However, Ultrasound guidance may help overcome many difficulties in regional techniques. But as expected, targets are more deeply situated in obese patients and the ultrasound beams are attenuated as they travel a greater distance through tissue layers. Additionally, when crossing a tissue boundary, a portion is reflected back to the transducer creating artifacts like speckling and clutter which are particular problems in the obese patient. [15] Few studies examined the use of ESPB in bariatric surgery [3,6,7], all indicating potential benefits of the technique in terms of opioid sparing and pain control. To date, the efficacy of ESPB has not been examined in superobese patient.

So we aim to compare the perioperative analgesic effect of bilateral ultrasound-guided ESPB with controls, Local bupivacaine infiltration to the trocar sites, in super obese patients undergoing bariatric surgery We hypothesis that ESBP provides good applicable modality of perioperative analgesia for superobese patients undergoing bariatric surgeries.

详细描述

Following approval from Ethics and Research Committee of Anaesthesia Department, Faculty of Medicine, Cairo University; 60 patients fulfilling inclusion criteria will be included in this randomized prospective comparative trial.

A.preoperative:

History will be taken from all patients. Age and then American Society Anaesthesiologists' (ASA) score will be recorded.

Preoperatively patients' laboratory investigations as complete blood picture, coagulation profile, liver and renal functions will be recorded. General examination will be carried out with examination of the back to exclude infection at the injection site and anatomical deformities.

Baseline vital signs will be recorded including non-invasive measurement of systolic, mean, diastolic arterial pressures, and HR and oxygen saturation. After inserting an intravenous (IV) access, the patient will be pre-medicated with metoclopramide in a dose 0.1-0.2 mg/kg.

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 (Participant)

盲法说明

Computer-generated sequence will be used for randomization and opaque envelopes will be used for concealment.

入排标准

年龄范围
18 Years 至 60 Years(Adult)
性别
All
接受健康志愿者

入选标准

  • Patient age >18 <60
  • Super Obese patients ; Body mass index(BMI) > 50 kg/m2
  • Both sexes
  • American Society of Anesthesiologists(ASA) physical status classes II and III
  • Patients scheduled for laparoscopic bariatric surgery i.e. sleeve gastrectomy and/or Roux-en-Y gastric bypass (RYGB)surgeries

排除标准

  • • Refusal of regional block
  • Patients with neurological, psychological disorders or those lacking cooperation
  • Patients scheduled for concomitant laparoscopic cholecystectomy or paraumbilical hernia repair or those with history of previous bariatric surgery or obstructive sleep apnea
  • Patients with anatomic abnormalities at site of injection, skin lesions or wounds at site of proposed needle insertion.
  • Patients with bleeding disorders defined as (INR >1.4) and/ or (platelet count <100,000/µL)
  • Patients with hepatic disease e.g. liver cell failure or hepatic malignancy or hepatic enlargement.
  • Patients who are allergic to amide local anesthetics.
  • Cases converted to open surgery will also be excluded from the study

研究组 & 干预措施

Erector Spinae block .

Active Comparator

the block will be performed preoperatively with 1mg midazolam administration intravenous , and 5 cm lidocaine 1% infiltration at each side prior to the block .

the patient will be placed in the lateral or sitting position . The block will be performed bilaterally by injecting 60 mL of 0.25% bupivacaine (30 mL into each side) [16] into the fascial plane between the deep surface of the Erector Spinae muscle and the transverse processes of the lumbar vertebrae laterally (at the most lateral part of the transverse process) and since it is a fascial plane block , the greater the volume of the local anaesthetic injected , the distribution will be better.

干预措施: ESPB (Procedure)

Erector Spinae block .

Active Comparator

the block will be performed preoperatively with 1mg midazolam administration intravenous , and 5 cm lidocaine 1% infiltration at each side prior to the block .

the patient will be placed in the lateral or sitting position . The block will be performed bilaterally by injecting 60 mL of 0.25% bupivacaine (30 mL into each side) [16] into the fascial plane between the deep surface of the Erector Spinae muscle and the transverse processes of the lumbar vertebrae laterally (at the most lateral part of the transverse process) and since it is a fascial plane block , the greater the volume of the local anaesthetic injected , the distribution will be better.

干预措施: midazolam and lidocaine (Drug)

local anaesthetic infiltration

Active Comparator

: the participant will receive 5 ml bupivacaine infiltration to each trocar site (total of 25 ml 0.5 %) at the beginning of the operation.

干预措施: local anaesthetic infiltration (Procedure)

local anaesthetic infiltration

Active Comparator

: the participant will receive 5 ml bupivacaine infiltration to each trocar site (total of 25 ml 0.5 %) at the beginning of the operation.

干预措施: Bupivacain (Drug)

结局指标

主要结局

Total opioid consumption

时间窗: 24 hours

(morphine equivalent dose) in both groups in 24hr postoperative (including Intraoperative fentanyl , and postoperative nalluphine).

次要结局

  • VAS score during first 24 hour postoperative(24 hours)

研究者

发起方
Amany Ahmed Eissa
申办方类型
Other
责任方
Sponsor Investigator
主要研究者

Amany Ahmed Eissa

lecturer of anesthesia& ICU

Kasr El Aini Hospital

研究点 (1)

Loading locations...

相似试验