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临床试验/NCT06531759
NCT06531759尚未招募2 期

Efficacy of Fentanyl Soaked Nasal Packs on Postoperative Pain in Nasal Surgeries.

Assiut University0 个研究点目标入组 100 人开始时间: 2024年9月1日最近更新:
适应症
干预措施

试验速览

阶段
2 期
状态
尚未招募
入组人数
100
主要终点
Efficacy of fentanyl soaked nasal packs on postoperative pain in nasal surgeries

研究概览

简要总结

Efficacy of fentanyl soaked nasal packs on postoperative pain in nasal surgeries.

详细描述

Postoperative pain is one of the commonest feared surgical side effect which can lead to patient dissatisfaction. It occurs due to a combination of inflammatory reaction and an injury to neural tissue caused by the surgical incision. Anterior nasal packing is not an innocuous procedure. It causes discomfort/pain (especially upon removal), nasal mucosa trauma, epiphora, local infection, discomfort in swallowing, sleep disturbances and, very rarely, toxic shock and vagal reflex. Although systemic opioids are traditionally used in the management of postoperative pain, their use is still limited by their possible side effects. Opioid drugs mimic the actions of the endogenous opioid peptides by interacting with specific receptors, the opioid receptors which are μ, δ and κ. The μ receptor is important in sensory processing, including the modulation of nociceptive stimuli, extrapyramidal functioning and in limbic and neuroendrocine regulation. There are two subtypes of the μ receptor, a high-affinity μ receptor and a low-affinity μ2 receptor. Recently a third μ subtype has been described that binds opioid alkaloids such as morphine, but has essentially no, or exceedingly low, affinity for the naturally occurring endogenous opioid peptides or non-alkaloid opioids such as fentanyl. Based on the hypothesis that mu (μ) opioid receptor expression increases at the site of inflammation. our study aims to assess the analgesic effect produced by local application of fentanyl through fentanyl soaked nasal packs following different nasal surgeries.

研究设计

研究类型
Interventional
分配方式
Na
干预模型
Single Group
主要目的
Treatment
盲法
None

入排标准

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

入选标准

  • Patients undergoing nasal surgeries requiring bilateral nasal packs.
  • Patients 18 years or older.

排除标准

  • Patients in whom fentany is contraindicated such as respiratory comorbidites (COPD and Asthma), hypersensitivity to fentanyl, liver diseases or had previous biliary tract surgeries
  • Systemic medical problems interfering with surgery.
  • Patients with traumatic conditions e.g fracture face or fracture nasal bone.
  • patients who refuse to take part in the study.
  • Patients with different nasal pathology in both sides e.g if partial turbinectomy is indicated in one side of the nose or patients with unilateral nasal polyp.

研究组 & 干预措施

Patients undergoing nasal surgeries requiring bilateral nasal packs.

Other

After performing the required nasal surgery, hydroxylated polyvinyl acetate packs (known as merocele packs) will be applied bilaterally in patients. The merocele on the left side will be injected with 5 ml volume of normal saline, while The merocele pack in the right side will be injected with 5 ml volume of the diluted fentanyl solution (1ml of fentanyl 50mcg diluted in 10 ml of normal saline).

干预措施: Fentanyl (Drug)

结局指标

主要结局

Efficacy of fentanyl soaked nasal packs on postoperative pain in nasal surgeries

时间窗: 24 hours postoperatively

Assessment of pain intensity will be done using The 11-point Numeric pain rating scale, subjects will be asked to give a pain score ranging from 0 to 10 interpreted as 0 is no pain and 10 is the worst pain they ever felt at intervals of 3, 6, 12 and 24 hours postoperatively.

次要结局

未报告次要终点

研究者

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

Aya Mahmoud Abd ElMonem Mahmoud

Aya Mahmoud Abd ElMonem

Assiut University

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