Postoperative PainPhase 2NCT06531759
Efficacy of Fentanyl Soaked Nasal Packs on Postoperative Pain in Nasal Surgeries.
A Phase 2 study testing Fentanyl in people with Postoperative Pain, run by Assiut University.
Trial summary
Efficacy of fentanyl soaked nasal packs on postoperative pain in nasal surgeries. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Postoperative Pain
- What is being tested?
- Fentanyl
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 100 participants
- Where
- No sites listed yet
- Study dates
- 1 Sep 2024to Nov 2025
- Phase
- Phase 2
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Patients undergoing nasal surgeries requiring bilateral nasal packs.
- Patients 18 years or older.
Who cannot join
- 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.
Trial locations and contacts
No sites are listed yet.
About this study
Efficacy of fentanyl soaked nasal packs on postoperative pain in nasal surgeries.
Read the detailed description
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.
- Conditions
- Postoperative Pain
- Being tested
- Fentanyl
- Medical subject headings
- Pain, Postoperative
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
FentanylDrug
Fentanyl soaked nasal packs.
| Study group | Role | What they receive |
|---|---|---|
| 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). Receives: Drug: Fentanyl |
What is being measured
The primary outcome is the main question the study is designed to answer.
Efficacy of fentanyl soaked nasal packs on postoperative pain in nasal surgeries
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.
Measured: 24 hours postoperatively
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted1 Aug 2024
- Study start1 Sep 2024 (estimated)
- Primary completionSep 2025 (estimated)
- Study completionNov 2025 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Postoperative PainStudies of the same condition, open and under way.
- More trials run by Assiut UniversityThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase 2
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Enrolment
- 100 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Assiut University
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Aya Mahmoud Abd ElMonem Mahmoud, Assiut University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06531759
- Sponsor's protocol ID
- Pain after nasal surgeries
- Status last verified
- Jul 2024
- First submitted
- 29 Jul 2024
- Last updated
- 1 Aug 2024
- Results posted
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
Study at a glance
From the registry record, last updated by the sponsor on 1 Aug 2024. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Efficacy of Fentanyl Soaked Nasal Packs on Postoperative Pain in Nasal Surgeries.
- ClinicalTrials.gov ID
- NCT06531759
- Acronym / sponsor ID
- Pain after nasal surgeries
- Conditions
- Postoperative Pain
- Phase
- Phase 2
- Study type
- Interventional
- Recruitment status
- Unknown status
- Enrolment
- 100 participants (estimated)
- Lead sponsor
- Assiut UniversityUniversity, hospital or other
- Study start
- 1 Sep 2024 (estimated)
- Primary completion
- Sep 2025 (estimated)
- Study completion
- Nov 2025 (estimated)
- First posted
- 1 Aug 2024 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
Efficacy of fentanyl soaked nasal packs on postoperative pain in nasal surgeries.
Detailed description
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.
Study design
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| Patients undergoing nasal surgeries requiring bilateral nasal packs. | Other | Drug: FentanylAfter 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). |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (2 listed)
- Patients undergoing nasal surgeries requiring bilateral nasal packs.
- Patients 18 years or older.
Key exclusion criteria (5 listed)
- 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.
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| FentanylFentanyl soaked nasal packs. | Drug | Patients undergoing nasal surgeries requiring bilateral nasal packs. |
Primary outcome
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.
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 1 Aug 2024.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Questions about this trial
What is this clinical trial studying?
A Phase 2 study testing Fentanyl in people with Postoperative Pain, run by Assiut University.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 2 inclusion and 5 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: status not confirmed, as of the sponsor's last update on 1 Aug 2024. Status can change between updates, so confirm with the study contact before making plans.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
What does this phase mean?
Phase 2 studies give the treatment to a larger group to see whether it has the intended effect and to keep checking safety.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
Are results available for this study?
Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
Contact Aya M. Abd ElMonem, Bachelor (01098242701, aia90713@gmail.com), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Efficacy of fentanyl soaked nasal packs on postoperative pain in nasal surgeries (time frame: 24 hours postoperatively). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 1 Aug 2024.