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临床试验/NCT04434339
NCT04434339已完成不适用

A Comparison Between Ultrasound-guided Erector Spinae Plane Block and Transversus Abdominis Plane Block for Postoperative Analgesia of Adult Patients Undergoing Ovarian Cancer Surgery Under General Anesthesia: Randomized, Controlled Study.

Cairo University2 个研究点 分布在 1 个国家目标入组 34 人开始时间: 2020年7月15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
34
试验地点
2
主要终点
postoperative tramadol consumption

研究概览

简要总结

Postoperative pain is one of the greatest patient concerns following any surgery. Although an increased emphasis has been placed on pain management, approximately 80% of surgical patients report postoperative pain with 86% of patients rating their pain as moderate, severe, or extreme.

In recent years, the increasing adoption of ultrasound-guided regional anesthesia for acute pain management parallels the rapid rise in the availability of ultrasound machines, facilitating description of a number of important fascial plane blocks blocking the dorsal, lateral and anterior cutaneous nerves of the thorax and abdomen. These new descriptions in blocks are supposed to be an advance in regional anesthesia due to its simplicity and lack of complications. These include the transversus abdominis plane block, rectus sheath block, quadratus lumborum block, pectoralis nerve block, serratus plane block, retrolaminar block, and now the Erector spinae block.

Although ESP and TAB blocks successfully reduced postoperative opioid consumption in previous studies, no study has ever compared their efficacy in postoperative analgesia of adult patients undergoing ovarian cancer surgery under general anesthesia thus in this randomized controlled study we are aiming to fill this gap in the literature.

Hypothesis Analgesia provided by the erector spine plane block is superior to that of transversus abdominis block in patients undergoing ovarian cancer surgery under general anesthesia.

详细描述

Introduction:

Postoperative pain is one of the greatest patient concerns following any surgery. Although an increased emphasis has been placed on pain management, approximately 80% of surgical patients report postoperative pain with 86% of patients rating their pain as moderate, severe, or extreme.

In recent years, the increasing adoption of ultrasound-guided regional anesthesia for acute pain management parallels the rapid rise in the availability of ultrasound machines, facilitating description of a number of important fascial plane blocks blocking the dorsal, lateral and anterior cutaneous nerves of the thorax and abdomen. These new descriptions in blocks are supposed to be an advance in regional anesthesia due to its simplicity and lack of complications. These include the transversus abdominis plane block, rectus sheath block, quadratus lumborum block, pectoralis nerve block, serratus plane block, retrolaminar block, and now the Erector spinae block.

The TAP is a potential anatomical space that lies between transversus abdominis and internal oblique muscles, where local anesthetic can be deposited, creating a non-dermatomal "field block.".This block can be placed before or during a surgery either by ultrasound guidance or by landmarking through the triangle of Petit (inferior lumbar triangle). Blocks can be placed either intra-abdominally prior to abdominal fascial closure or by transdermal injection. Transversus abdominis plane (TAP) blocks can provide reliable relief of somatic incisional pain. However, the lack of reliable visceral pain relief with TAP blocks may necessitate additional modes of analgesia.

Previous studies have investigated the efficacy of TAP blocks in benign gynecology, general surgery,and non-ovarian gynecologic oncology.These studies have had mixed outcomes, but a recent meta-analysis has demonstrated an overall reduction in pain and opioid usage associated with TAP blocks in laparotomy.

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
Double (Participant, Care Provider)

入排标准

年龄范围
18 Years 至 65 Years(Adult, Older Adult)
性别
Female
接受健康志愿者

入选标准

  • female Patients undergoing ovarian cancer surgery under general anesthesia with ASA I-II and Age ≥ 18 and ≤ 65 Years

排除标准

  • Patient refusal.
  • uncooperative patients
  • Cardiovascular disease in the form of Uncontrolled hypertension, IHD, AF, cardiomyopathy with EF <50%
  • Cerebrovascular insufficiency in the form of TIAs, REND, stroke, cerebral hemorrhage, brain tumour, epilepsy
  • Coagulation defects with INR>1.5 platelets count< 80000
  • hepatic insufficiency with ALT and AST > twice normal, total bilirubin >1.5 , PC < 80%.
  • Hypersensitivity to the study drugs.
  • Pregnant patients
  • patients receiving vasoactive drugs or beta blockers

结局指标

主要结局

postoperative tramadol consumption

时间窗: within 24 hours after surgery

postoperative tramadol consumption in mg

次要结局

未报告次要终点

研究者

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

Sherif Abdullah Mohamed

Lecturer of anesthesia

Cairo University

研究点 (2)

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