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临床试验/NCT04382209
NCT04382209Unknown不适用

Evaluation of Ultrasound-Guided Erector Spinae Plane Block for Postoperative Analgesia in Adult Patients Undergoing Major Abdominal Surgery: A Prospective Randomized Controlled Clinical Trial

Suez Canal University2 个研究点 分布在 1 个国家目标入组 56 人开始时间: 2020年6月1日最近更新:
适应症

试验速览

阶段
不适用
入组人数
56
试验地点
2
主要终点
Opioid consumption

研究概览

简要总结

Aim of the work To evaluate the efficacy of ultrasound-guided erector spinae plane block for management of postoperative pain in patients undergoing major abdominal surgery under general anesthesia.

Hypothesis

  • Null hypothesis: The investigators suppose that ultrasound-guided erector spinae plane block has no post-operative analgesic effect in patients undergoing major abdominal surgery.
  • Alternative hypothesis: The investigators suppose that ultrasound-guided erector spinae plane block has post-operative analgesic effect in patients undergoing major abdominal surgery.

Study objectives

Primary Objective:

Comparison of opioid consumption in patients receiving erector spinae plane block in relation to control group.

Secondary Objective:

  1. Evaluate the hemodynamics (blood pressure, heart rate) and respiratory rate in patients receiving erector spinae plane block during postoperative period at 0, 2, 4, 6, 8, 12,24 hours.
  2. Assessment of numeric rating scale (NRS) in patients receiving erector spinae plane block during rest and movement during postoperative period at 0, 2, 4, 6, 8, 12,24 hours.

详细描述

Introduction:Thoracic epidural analgesia is still considered the gold standard for postoperative analgesia in abdominal surgery; however, concerns regarding side effects such as hypotension and motor blockade, as well as the risk of major complications such as epidural hematoma and abscess, have led some to question its role. Abdominal wall blocks such as the transversus abdominis plane (TAP) block have been proposed as alternatives; nevertheless they have their own limitations: dermatomal coverage is limited, catheter techniques are cumbersome to perform given the proximity to the surgical field, and a recent meta-analysis found the TAP block to be marginally effective in this context. The erector spinae plane (ESP) block is a novel paraspinal plane block first described for thoracic analgesia when performed at the T5 level, but more recently has also been shown to be effective in providing extensive somatic and visceral abdominal analgesia when performed at the T7-9 level.

Morphine administration is the cornerstone of pain therapy, but acute tolerance after opioid exposure has been described as early as the immediate postoperative period.Enhanced recovery after surgery, which involves implementation of evidence-based multimodal procedure- specific perioperative care pathways, has been shown to improve postoperative outcome and reduce length of hospital stay. One of the major elements of a successful program for enhanced recovery after surgery is the provision of optimal postoperative analgesia to facilitate ambulation and rehabilitation therapy.

An ideal multimodal analgesic technique would include local/regional analgesic techniques (i.e., neuraxial blocks [epidural and paravertebral analgesia], field blocks [e.g., transversus abdominis plane blocks and rectus sheath block], and surgical site infiltration) combined with acetaminophen and either a nonsteroidal antiinflammatory drug or a cyclooxygenase-2 selective inhibitor and also analgesic adjuncts such as single intraoperative dose dexamethasone.

The origin of pain from abdominal surgery is multifactorial, including a parietal (or somatic) component originating from the surgical incision and a visceral component originating from the peritoneum and the manipulation of the intra-abdominal structures. The somatic innervation of the anterior abdominal wall arises from the thoracolumbar spinal nerves (i.e., T6-L1).A recent cadaveric study assessing the course of anterior abdominal wall nerves found that there is extensive branching and communications between the abdominal nerves.The communications occur at several sites, including the intercostal plexus, anterolateral large branch communication, the transversus abdominis plane plexus that lies between the internal oblique and the transversus abdominis muscles (T9-L1 segmental nerves adjacent to the deep circumflex iliac artery), and the rectus sheath plexus that comprises all the segmental nerves (i.e., T9-L1) adjacent to the deep inferior epigastric artery. In most cases, these nerves also pierce the posterior surface of the rectus abdominis muscle.The muscular and cutaneous branches of these segmental nerves enter the muscle and finally terminate in the skin. The skin above the umbilicus is supplied by the cutaneous nerves derived from T6 to T9, the area around the umbilicus is innervated by T10, and the skin below the umbilicus is derived from T11, T12, and L1.

It is now evident that the peritoneum is a metabolically active organ and responds to surgical insult by manifesting a local and systemic immunologic and inflammatory response.The peritoneum consists of "silent nociceptors" that are activated by surgical injury and intraperitoneal inflammation and contribute to visceral pain. The neuro-immuno-humoral pain pathways involved in abdominal surgery include somatic and autonomic nerves such as the afferent fibers of the abdominal vagus nerve. Parasympathetic activation has been shown to influence perioperative outcome, as reduced vagal tone augments inflammation and increases gastrointestinal dysfunction.

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
Triple (Participant, Care Provider, Investigator)

入排标准

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

入选标准

  • Patients aged between 21 - 60 years
  • Patients undergoing major abdominal surgery:
  • The indication for operation may be for benign or malignant disease.
  • Major surgery is defined as an operation of anticipated duration of more than one hour.

排除标准

  • Patients with history of bleeding diathesis or on anticoagulant.
  • Patients with relevant drug allergy.
  • Patients with psychiatric illnesses, opioid dependence; alcohol or drug abuse that would interfere with perception and assessment of pain were excluded from the study.
  • Compensated or decompensated myocardial insufficiency.
  • Decreased renal function (serum creatinine <2.0 mg/dL).
  • Infection of the skin at the site of needle puncture area

结局指标

主要结局

Opioid consumption

时间窗: 24 hours after surgery

Meperidine consumptions for both group will be recorded

次要结局

  • Numeric rating scale (NRS)(24 hours after surgery)

研究者

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

Bassem Mohammad Kamel EL-Ayashy

Assistant lecturer

Suez Canal University

研究点 (2)

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