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临床试验/NCT02923869
NCT02923869已完成2 期

Comparative Study Between Levobupivacaine and Bupivacaine for Nerve Block During Pediatric Primary Cleft Palate Surgery

Assiut University1 个研究点 分布在 1 个国家目标入组 60 人开始时间: 2016年1月最近更新:
适应症
干预措施
相关药物

试验速览

阶段
2 期
状态
已完成
入组人数
60
试验地点
1
主要终点
recovery after surgery

研究概览

简要总结

A cleft deformity of the lip and/or palate is one of the commonest major birth defects.

Primary surgery of cleft palates (CP) varies according to the different surgical teams. Its peculiarity lies in the numerous care management protocols proposed according to the surgical techniques used, operating time (between M3 and M18 of life), anesthetic technique and postoperative management.

This surgery must be associated to a specific care management because of potential associated complications, especially the risk of obstruction of the upper respiratory tract and respiratory distress majored by the use of morphine anesthetics during and after surgery.

Adequate postoperative analgesia in children is a vital part of perioperative care. Regional block given preoperatively in combination with general anesthesia (GA) provides good preemptive analgesia. It is associated with perioperative hemodynamic stability, rapid and complete recovery and reduced analgesic requirement in the postoperative period.

CP repair is painful, necessitating high doses of intravenous (IV) opioids. Therefore, the risk of postoperative respiratory depression and airway obstruction is important, and continuous monitoring is required during the initial 24-h postoperative period. Cleft palate surgery is not only painful, but may also compromise the airway, particularly in children with craniofacial syndromes. Opiate analgesia has the potential to further compromise the airway, whereas bilateral maxillary nerve block can provide analgesia without the risk of respiratory depression in these vulnerable patients. Bilateral maxillary nerve block is performed using a suprazygomatic approach and is based on a computer tomography study.

The nerve supply to the hard and soft palate is from the greater and lesser palatine nerves passing through the sphenopalatine ganglion. The maxillary nerve (MN) provides sensory innervation of the anterior and posterior palate, the upper dental arch, the maxillary sinus, and the posterior nasal cavity. Maxillary nerve block (MNB) through the infrazygomatic route, used for the treatment of trigeminal neuralgia in adults, permits anesthesia of the entire palatine territory. However, this nerve block has led to complications such as orbital puncture, intracranial injection, maxillary artery puncture, or posterior pharyngeal wall injury.

详细描述

A prospective randomized controlled double blind study using a computer generated randomization scheme will be conducted in Assiut University Hospitals and will be carried out on 60 children undergoing primary cleft palate repair surgery. Combined general anesthesia and regional bilateral maxillary nerve block (MNB) will be used for anesthesia in these surgeries.

The study drugs (used in MNB) and randomization will be prepared by the second anesthetist. The MNB and observed parameters (intraoperative and postoperative) will be done by the first anesthetist.

Children will be randomly allocated into one of two groups of 30 patients each:

Group L: children will receive 0.15 ml/kg of 0.2% Levobupivacaine

Group B: children will receive 0.15 ml/kg of 0.2% Bupivacaine

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, 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

入选标准

  • Age 1-10 years
  • Both sexes
  • ASA I or II
  • Primary cleft palate

排除标准

  • Any allergy to local anesthetics
  • Coagulation disorders
  • Local infection or injury at site of MNB
  • Concomitant rhinoplasty
  • Associated other congenital anomalies
  • History of upper or lower airway diseases
  • History of sleep apnea

研究组 & 干预措施

Group L

Active Comparator

Children will receive 0.15 ml/kg of 0.2% Levobupivacaine

干预措施: Levobupivacaine (Drug)

Group B

Active Comparator

Children will receive 0.15 ml/kg of 0.2% Bupivacaine

干预措施: Bupivacaine (Drug)

结局指标

主要结局

recovery after surgery

时间窗: 2 hours

sedation of the child in the recovery room will be monitored

次要结局

  • FLACC score(24 hours)
  • Intraoperative and Postoperative Complications(24 hours)

研究者

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

MOHAMED F. MOSTAFA

Lecturer of Anesthesia and Intensive Care

Assiut University

研究点 (1)

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