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临床试验/NCT04368195
NCT04368195已完成不适用

Evaluation of Ultrasound-guided Erector Spinae Plane Block for Postoperative Analgesia in Laparoscopic Sleeve Gastrectomy: A Prospective, Randomized, Controlled Clinical Trial

Security Forces Hospital4 个研究点 分布在 1 个国家目标入组 50 人开始时间: 2020年12月30日最近更新:
适应症

试验速览

阶段
不适用
状态
已完成
入组人数
50
试验地点
4
主要终点
NRS pain score at 18th hours

研究概览

简要总结

This study will help us in understanding the role of erector spinae block (ESPB) for postoperative pain control in patients undergoing upper GI laparoscopy surgeries. The surgeries included in this group include laparoscopic cholecystectomy, laparoscopic gastrectomy, laparoscopic umblical or epigastric hernia repair. Patients aged between 18 and 65 years, scheduled to undergo any upper GI laparoscopy surgeries with an ASA score of 1 or 2 will be included in the study. This is a prospective randomised controlled trial which will compare two groups receiving either erector spinae block or no block for postoperative pain control after upper GI laparoscopy surgeries

详细描述

Research Proposal and significance Postoperative analgesia should include strategies to reduce side effects. Intravenous analgesics are generally considered to be adequate for pain management in upper GI laparoscopic surgeries. However opioids can lead to nausea, vomiting and itching while NSAIDs affect the gastric, hepatic and renal systems and wound healing. Reducing opioid requirements during the perioperative period is among the current goals of enhanced recovery programs. The objective is to reduce all potential opioid-related side-effects. Therefore, multimodal analgesics including regional blocks decrease the use of other analgesics and therefore decrease side effects.

Objective The aim of this study is to evaluate the effect of Erector spinae block (ESPB) on postoperative pain in upper GI laparoscopy surgeries, which leads to both visceral and somatic pain.

Research review In this study, the surgeries included in upper GI laparoscopic surgeries are laparoscopic cholecystectomy, laparoscopic gastrectomy, laparoscopic umblical or epigastric hernia repair.

n upper GI laparoscopy surgeries, postoperative pain is caused by two reasons; one is somatic pain from the trocar entry incisions and additionally peritoneal distention and diaphragm irritation due to high intra-abdominal pressure and CO2 insufflations lead to visceral pain as well. Therefore, any analgesic protocol for these surgeries must be effective on both sources of pain.

Regional block techniques studied and considered part of multimodal anesthesia include transversus abdominis plane block (TAP), oblique subcostal transversus abdominis plane block (OSTAP or STAP) and paravertebral block. Apart from paravertebral block, these techniques only effect somatic pain and can therefore be inadequate in some cases. Ultrasound Guided paravertebral block is an advanced regional anesthesia technique. When considering that the pleura forms one boundary of the paravertebral space, ESPB can be considered an easier technique to perform. It is also safer because the needle remains behind the transverse process. However, non-inferiority studies comparing ESPB and paravertebral block are required. Erector Spinae Plane Block (ESPB) - first recently described for the treatment of thoracic neuropathic pain, is a peri-paravertebral regional anesthesia technique that has since been reported as an effective technique for prevention of postoperative pain in various surgeries. In ESPB, local anesthetic is reported to be administered in to the interfascial plane between the transverse process of the vertebra and the erector spinae muscles, spreading to multiple paravertebral spaces. Case reports have reported that ESPB effects both the ventral and dorsal rami and leading to blockage of both visceral and somatic pain. Anatomical dissection indicates that the likely mechanism of action is diffusion of local anaesthetic anteriorly through the connective tissues and ligaments spanning the adjacent transverse processes and into the vicinity of the spinal nerve roots. This is consistent with other reports of successful analgesia following injection into a similar tissue plane in the thorax.

研究设计

研究类型
Interventional
分配方式
Randomized
干预模型
Parallel
主要目的
Prevention
盲法
Triple (Participant, Investigator, Outcomes Assessor)

盲法说明

Double blind

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 aged between 18 and 65years, scheduled to undergo any upper GI laparoscopy surgeries with an ASA score of 1 or 2 will be included in the study. The surgeries included in this group include laparoscopic cholecystectomy, laparoscopic gastrectomy, laparoscopic umblical or epigastric hernia repair.
  • Written informed consent for general anesthesia and all procedures will be obtained from all patients.

排除标准

  • Patients who refused enrollment or later requested removal for the study, those who are unable to give informed consent and patients with either contraindications for regional anesthesia, known allergy to local anesthetics, bleeding diathesis, use of anticoagulants or corticosteroids, inability to operate patient controlled analgesia (PCA) system, psychiatric disorders or use of psychiatric medications and conversion to open laparotomy will not be included in the study.

结局指标

主要结局

NRS pain score at 18th hours

时间窗: 18th hour

Primary outcome measures at commencement of the study will be NRS pain score at 18th hours postoperatively both at rest and when coughing.

次要结局

  • Adverse events(24 hours)
  • Analgesic consumption(24 hours)

研究者

申办方类型
Other
责任方
Principal Investigator
主要研究者

Anwar ul Huda

Consultant Anaesthetist

Security Forces Hospital

研究点 (4)

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