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临床试验/NCT05755334
NCT05755334尚未招募4 期

Ropivacaine Pharmacokinetics After Erector Spinae Block in Children Undergoing Posterior Spinal Fusion

McGill University Health Centre/Research Institute of the McGill University Health Centre0 个研究点目标入组 46 人开始时间: 2023年6月1日最近更新:
适应症
干预措施
相关药物

试验速览

阶段
4 期
状态
尚未招募
发起方
入组人数
46
主要终点
Opioid Consumption

研究概览

简要总结

The primary aim is to evaluate the analgesic efficacy of either technique by measuring cumulative morphine consumption in the first 24 hours after an erector spinae plane block with 2 ml/kg of ropivacaine 0.1% (2 ml/kg) or 1 ml/kg of ropivacaine 0.2%.

The secondary aim of this study is to describe the pharmacokinetics of ropivacaine 0.1% and ropivacaine 0.2% after erector spinae block in children undergoing posterior spinal fusion.

详细描述

Pain is of particular concern in pediatric patients undergoing posterior spinal fusion surgery. In children, posterior spinal fusion is performed for neuromuscular or adolescent idiopathic scoliosis. Posterior spinal fusion is highly invasive and entails the fusion of multiple adjacent vertebral bodies. The surgery generates profound pain from multiple tissue sources including bones, ligaments, intervertebral discs, nerve root sleeves, fascia and muscles. In these patients, greater perioperative pain has been shown to increase the risk of chronicity, prolonged pain medication use, delayed rehabilitation and delayed return of function. Patients experiencing moderate-to-severe pain in the acute postoperative period were more likely to report higher levels of pain severity, use more pain medication, and miss a greater number of school/workdays due to back pain in the last three month.

The mainstream perioperative pain therapy in patients undergoing posterior spinal fusion is opioid-based. Prolonged intravenous opioids, however, are associate to prolonged length of stay. As a results, adjuvants of such as acetaminophen, nonsteroidal anti-inflammatory drugs and ketamine are routinely used in some centers.

Recently, the erector spinae plane (ESP) block has been proposed as an effective adjuvant in the multimodal analgesia after posterior spinal fusion .

The erector spinae plane block is a paraspinal fascial plane block in which the needle placement is between the erector spinae muscle and the thoracic transverse processes, and a local anesthetic is administered, blocking the dorsal and ventral rami of the thoracic and abdominal spinal nerves. This blockage of the dorsal and ventral rami of the spinal nerves helps to achieve a multi-dermatomal sensory block of the anterior, posterior, and lateral thoracic and abdominal walls. The erector spinae plane block has been successfully implemented in the multimodal analgesia management in both adults and children.

However, there is limited information about the pharmacokinetics of ropivacaine after erector spinae plane blocks. In adults, studies reported potentially neurotoxic plasma concentrations after the injection of a 'safe" (100 mg) dose of ropivacaine in the transversus plane. In contrast, in children, plasma concentrations of ropivacaine after ilioinguinal-iliohypogastric, transversus plane block appear to remain well below the neurotoxic blood concentration for total ropivacaine (2.2 μg/ml). Similarly, plasma concentration after erector spinae plane block have been reported to be safe, but data are limited to a single small investigation. A recent pilot study in children showed high blood concentrations (0.56 μg/L) of unbound ropivacaine exceeding its potential neurotoxic blood concentration (0.15 μg/L), but concentrations of total ropivacaine below the neurotoxic (and cardiovascular) threshold. after erector spinae plane block with ropivacaine at high concentrations (0.5%).

研究设计

研究类型
Interventional
分配方式
Randomized
干预模型
Parallel
主要目的
Other
盲法
None

入排标准

年龄范围
8 Years 至 18 Years(Child, Adult)
性别
All
接受健康志愿者

入选标准

  • Patients ≥ 8 year older and > 25 kg undergoing posterior spinal fusion surgery
  • Parents or legal guardians that are fluent in French of English

排除标准

  • Patients with any contraindication to locoregional anesthesia
  • Patients that are expected to be intubation for a prolonged period of time after surgery
  • Patients with anemia (hematocrit < 30%) before surgery or at time of the first study blood draw
  • Patients that do not receive an erector spinae plane block
  • Parents or legal Patient/legal guardian that to not consent to participate in the study

研究组 & 干预措施

Ropivacaine 0.1%

Active Comparator

Erector spinae plane block with 2 ml/kg of ropivacaine 0.1%.

干预措施: Ropivacaine (Drug)

Ropivacaine 0.2%

Experimental

Erector spinae plane block with 1 ml/kg of ropivacaine 0.2%.

干预措施: Ropivacaine (Drug)

结局指标

主要结局

Opioid Consumption

时间窗: 24 hours after surgery

Total opioid consumption after surgery

Post-operative Complications

时间窗: 24 hours after the surgery

The number of anesthesia and surgical related complications

Pain during surgery

时间窗: During the the surgery

Severity of pain during surgery during measured by heart rate variability

Pain after surgery

时间窗: 24 hours after the surgery

Severity of pain after surgery measured by heart rate variability

次要结局

  • Secondary outcome(During the and 24 hours after the surgery)

研究者

发起方
McGill University Health Centre/Research Institute of the McGill University Health Centre
申办方类型
Other
责任方
Principal Investigator
主要研究者

Gianluca Bertolizio

Principle Inverstigator

McGill University Health Centre/Research Institute of the McGill University Health Centre

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