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NCT Number: NCT06531759

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

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

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Key information

About this study

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.

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

Inclusion criteria

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

Exclusion criteria

  • 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.

Treatment and study plan

Fentanyl

Drug

Fentanyl soaked nasal packs.

Primary outcomes

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

    Time frame: 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.

Study contacts

Contact information is provided by the study sponsor or research team.

Aya M. Abd ElMonem, Bachelor

CONTACT

[email protected]

01098242701

Hamza ElShafiy

CONTACT

[email protected]

01002906798

Sponsors and collaborators

Lead sponsor

Assiut University

Other

Registry information

Important dates

Study start
2024
Primary completion
2025
Study completion
2025
First posted
Aug 1, 2024
Registry last updated
Aug 1, 2024

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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