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临床试验/NCT06167187
NCT06167187招募中不适用

Is Inferior Alveolar Nerve Block Beneficial in Fracture Mandibular Surgeries? A Randomised Controlled Trial

Ain Shams University1 个研究点 分布在 1 个国家目标入组 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
不适用
状态
招募中
入组人数
46
试验地点
1
主要终点
The time of the first dose of fentanyl rescue analgesia intraoperative

研究概览

简要总结

The aim of the study is to assess the efficacy of adding of pre-emptive inferior alveolar nerve block compared to the conventional systemic intravenous analgesia in controlling perioperative pain in fracture mandibular surgeries.

详细描述

Opioid drug administration is a common technique to reduce pain from surgical trauma. However, the use of large doses of opioid drugs during and after surgery can be associated with an increased incidence of multiple side effects such as; ventilatory depression, sedation, nausea, vomiting, pruritus, difficult voiding and ileus.

In maxillofacial surgeries in which patients often receive maxillomandibular fixation these side effects are troublesome to the patient and at worst case scenario can cause a life-threatening complications. Ventilatory depression and vomiting are the most serious side effects especially in early postoperative hours. Various methods have been proposed to minimize these side effects. Nerve block with long-acting local anesthesia is a proposed technique in this regard.

In maxillofacial operations, bupivacaine is a highly efficient long-acting local anesthetic and has been used as a safe local anesthetic for neuroanalgesia after cleft lip operation or third molar surgery alone or in combination with low-power laser and diclofenac.

Inferior alveolar nerve block is considered as gold standard for sensory block of the hemi mandible. It can provide adequate anesthesia and analgesia for one side of the mandibular teeth and gingival mucosa, the body and inferior ramus of the mandible, the anterior two-thirds of the tongue and floor of the mouth cavity.

The inferior alveolar nerve (IAN) block is a widely used regional anaesthetic nerve block for the mandible. The most commonly used technique for IAN block is called the direct approach which include inserting the needle into the pterygomandibular raphae by penetrating the buccinators muscle. Once in this space, the aim is to inject the local anaesthetic solution besides the inferior alveolar nerve before it enters the mandibular foramen.

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, Care Provider)

入排标准

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

入选标准

  • Age group: 18 - 65 years old.
  • American Society of Anesthesiologists (ASA) Physical Status Class I to III
  • Scheduled for fracture mandible fixation.

排除标准

  • Refusing to participate in the study.
  • History of allergy to the medications used in the study.
  • Contraindications to regional anesthesia (including coagulopathy and local infection).
  • Psychiatric disorders.

研究组 & 干预措施

Study group (IAN block group)

Active Comparator

patients will receive bilateral inferior alveolar nerve block. 23 patients

干预措施: bilateral inferior alveolar nerve block (Procedure)

control group

Active Comparator

patients will not receive the block and will receive intravenous multimodal analgesia according to standard protocol.

23 patients

干预措施: Ketorolac and fentanyl (Drug)

结局指标

主要结局

The time of the first dose of fentanyl rescue analgesia intraoperative

时间窗: Throughout the surgery

guided by hemodynamic changes

Total amount of additional intraoperative fentanyl rescue analgesia

时间窗: Throughout the surgery

guided by hemodynamic changes

The time from recovery to the first dose pethidine rescue analgesic

时间窗: 24 hours postoperatively

guided by visual analogue scale.

Total amount of pethidine postoperative rescue analgesic

时间窗: 24 hours postoperatively

guided by visual analogue scale.

次要结局

  • Incidence of complications related to the block(24 hours postoperatively)

研究者

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

mohamed atef

assistant lecturer of anesthesia

Ain Shams University

研究点 (1)

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