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临床试验/NCT06873906
NCT06873906尚未招募3 期

Comparative Study Between Deep Parasternal Intercostal Plane Block Versus Erector Spinae Plane Block in Pediatric Cardiac Patients Undergoing Primary Repair of Septal Defects Via Median Sternotomy

Ain Shams University1 个研究点 分布在 1 个国家目标入组 45 人开始时间: 2025年3月20日最近更新:
适应症
干预措施
相关药物

试验速览

阶段
3 期
状态
尚未招募
入组人数
45
试验地点
1
主要终点
Time of the first request for postoperative analgesics

研究概览

简要总结

In this study we are aiming to compare the Erector Spinae Plane Block and the Deep Parasternal intercostal plane block as regard to their technique, application and outcome in order to describe the most suitable method for pediatric cardiac patients undergoing primary repair of septal defects

The primary outcome of this study will be the time of the first request for postoperative analgesics by FLACC pain scale more than 4 The secondary outcomes will be the total postoperative analgesic consumption, time for extubation, the incidence of nausea and vomiting, hemodynamic instability, onset of ambulation and any other complications on the first day after surgery

Participants will be enrolled in this double-blinded randomly allocated using computer-based randomization into three groups. Group 1 will receive bilateral deep parasternal intercostal plane block. Group 2 will receive bilateral erector spinae plane block. Group 3 will receive conventional analgesic regimen without having a regional block

详细描述

Pediatric cardiac surgery involving median sternotomy can be associated with significant postoperative pain. Poorly controlled pain following cardiac surgery has been shown to be a risk factor for increased morbidity, including severe cardiopulmonary dysfunction, hypercoagulability, and immunosuppression.

Post-operative pain management, which provides effective analgesia, minimizes side effects and contributes to enhanced recovery after surgery, is a unique challenge in the pediatric cardiac surgery population. The ideal post-operative analgesic regimen would enable early separation from mechanical ventilation, decrease opioid consumption, and expedite discharge from the intensive care unit.

Systemic opioids and non-steroidal anti-inflammatory drugs have been the mainstay for treating pain during the perioperative period in children undergoing median sternotomy for cardiac surgery. The traditional high-dose opioid approach is associated with a decreased stress response but at the expense of prolonged mechanical ventilation, and increased opioid-related side effects. NSAIDs are effective as part of a multimodal analgesic approach, but their use can be limited due to concerns regarding coagulopathy or impairment of renal function.

Regional anesthesia is becoming increasingly popular in pediatric cardiac surgery for its opioid sparing effects. By blocking the afferent impulses from surgical sites, the need for supplemental opioids is reduced. Neuraxial catheters, while effective, are often not utilized in the setting of full heparinization and coagulopathy due to the small yet significant risk of epidural hematoma formation. Paravertebral blocks have similar risk and side effect profiles to neuraxial catheters and require blocks to be performed bilaterally with a posterior approach. Truncal blocks such as erector spinae plane blocks, as well as superficial and deep parasternal blocks, have been shown to provide adequate pain relief for cardiac surgery, and have been gaining popularity.

Appropriate pain relief from a sternotomy incision can be achieved by blocking the second to sixth thoracic intercostal nerves. The newer ultrasound-guided deep parasternal block (previously known as transversus thoracic muscle plane block, involves deposition of a local anesthetic between the internal intercostal and transversus thoracic muscles and effectively blocks the anterior branches of intercostal nerves T2-6.

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
1 Year 至 10 Years(Child)
性别
All
接受健康志愿者
否

入选标准

  • •Pediatric patients with acyanotic heart disease
  • •Patients with septal defect undergoing primary repair
  • •ASA Ⅰ and Ⅱ

排除标准

  • •Patient's guardian refusal of procedure or participation in the study.
  • •Patients with hemodynamic instability
  • •Preexisting infection at the block site
  • •Allergy to local anesthetics
  • •Psychiatric illness
  • •Abnormal coagulation profile
  • •Preoperative ejection fraction less than 35%
  • •Recurrent ventricular arrhythmias
  • •Emergency Surgery
  • •Redo surgeries

研究组 & 干预措施

Deep Parasternal Intercostal Plane Block

Active Comparator

Patients will receive bilateral deep parasternal intercostal plane block.

干预措施: Deep Parasternal intercostal plane block (Procedure)

Erector Spinae plane block

Active Comparator

Patients will receive bilateral erector spinae plane block

干预措施: Erector Spinae Plane Block (Procedure)

conventional analgesic regimen

Active Comparator

patients will receive conventional analgesic regimen

干预措施: conventional analgesic regimen (Drug)

结局指标

主要结局

Time of the first request for postoperative analgesics

时间窗: 24 hours

The time of the first request for postoperative analgesics by Face, Legs, Activity, Cry, and Consolability (FLACC) pain scale more than 4. Patients will be assessed at 0, ½, 1, 2, 4, 6, 8, 12, 24 hours.

次要结局

  • Total postoperative analgesic consumption.(24 hours)
  • Time for extubation(24 hours)
  • Incidence of nausea(24 hours)
  • Hemodynamic instability(24 hours)
  • Onset of ambulation(24 hours)
  • incidence of vomiting(24 hours)

研究者

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

Sarah Ahmed Hanee Abdelmohaimen Bakr

Assisstant Lecturer

Ain Shams University

研究点 (1)

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