跳至主要内容
临床试验/NCT07069101
NCT07069101招募中不适用

The Effect of Continuous Erector Spinae Block Versus Continuous Edge of Laminar Block on The Quality of Analgesia and Diaphragmatic Excursion in Patients With Multiple Rib Fractures. A Prospective Randomized Trail.

Tanta University1 个研究点 分布在 1 个国家目标入组 70 人开始时间: 2024年11月1日最近更新:
适应症
干预措施

试验速览

阶段
不适用
状态
招募中
入组人数
70
试验地点
1
主要终点
Total morphine consumption

研究概览

简要总结

This prospective randomized clinical trial aims to compare the effect of continuous erector spinae plane block versus continuous edge of laminar block on the quality of analgesia and diaphragmatic excursion in patients with unilateral traumatic multiple rib fractures.

详细描述

Rib fractures occur in up to 12% of all trauma patients, most commonly due to blunt thoracic trauma, and pose a significant health care burden with their associated morbidity and mortality.

The erector spinae plane block (ESB) is a myofascial plane technique in which a needle is inserted under ultrasound guidance deep to the erector spinae muscle group, allowing an infusion of local anesthetic to diffuse to both the dorsal and ventral rami of the spinal nerves, thereby supplying the rib cage. This technique can be used as a single-shot method or to facilitate the placement of a catheter, allowing for continuous infusion and/or intermittent bolus to provide long-lasting analgesia.

The edge of laminar block (ELB) is a novel technique in which local anesthetics are injected at the lateral edge of the lamina. It has been proven to provide sensory analgesia during rib fractures.

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
Double (Participant, Outcomes Assessor)

入排标准

年龄范围
21 Years 至 65 Years(Adult, Older Adult)
性别
All
接受健康志愿者
否

入选标准

  • •Aged between 21 and 65 years.
  • •Both sexes.
  • •With unilateral traumatic multiple fracture ribs (≥ 3), admitted to the surgical intensive care unit within the first day of trauma.

排除标准

  • •Patients' rejection.
  • •Body mass index ≥ 35 (kg/m2).
  • •Bleeding and Coagulation disorders.
  • •Known hypersensitivity to the study drugs.
  • •Vertebral deformity.
  • •Respiratory, cardiac, renal or hepatic dysfunction.
  • •Patients with major trauma involving extra-thoracic structures (e.g., head, spine, pelvis, and abdominal visceral injuries).
  • •Mental or cognitive dysfunction,
  • •History of chronic analgesic or drug abuse.
  • •Local infection at the site of the block.

研究组 & 干预措施

Erector spinae group

Experimental

Patients will receive continuous ipsilateral erector spinae plane block.

干预措施: Erector spinae block (Other)

Edge of lamina group

Experimental

Patients will receive continuous ipsilateral edge of laminar block.

干预措施: Edge of lamina block (Other)

结局指标

主要结局

Total morphine consumption

时间窗: 4 days postoperatively

If the Numeric Rating Scale (NRS) is 4 or more IV morphine 3mg will be given.

次要结局

  • Degree of pain(4 days postoperatively)
  • Diaphragmatic excursion(4 days postoperatively)
  • Incidence of adverse events(4 days postoperatively)
  • Forced vital capacity(4 days postoperatively)
  • Forced expiratory volume 1(4 days postoperatively)
  • Forced expiratory volume 1 (FEV1)/Forced vital capacity (FVC)(4 days postoperatively)

研究者

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

Heba Abdel Hamid Muhammed

Assistant Lecturer of Anesthesiology, Surgical Intensive Care and Pain Medicine Department, Faculty of Medicine, Tanta University, Tanta, Egypt.

Tanta University

研究点 (1)

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