Analgesia During Removal of Nasal Pack After Nasal SurgeryPhase 2fentanylNCT04410588
Effect of Fentanyl With Topical Levobupivacaine With Nasal Packing in Endoscopic Nasal Surgery
A Phase 2 study testing Fentanyl + Topical Levobupivacaine and levobupivacaine in people with Analgesia During Removal of Nasal Pack After Nasal Surgery, run by Assiut University at 1 site in Egypt.
Trial summary
the Investigators aim to study the effect of fentanyl with topical levobupivacaine with nasal packing in endoscopic nasal surgery Read more about this study
- Who is it for?
- Ages 18 to 60 years
- Conditions the study is for
- Analgesia During Removal of Nasal Pack After Nasal Surgery
- What is being tested?
- Fentanyl + Topical Levobupivacaine and levobupivacaine
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 75 participants
- Where
- 1 siteEgypt
- Study dates
- 20 Jun 2020to Aug 2021
- 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 to 60 years
- All sexes
- No healthy volunteers
- Adult
Who may be able to join
None listed.
Who cannot join
- Patients will also be excluded if any perioperative cardiovascular or respiratory event occurred which the anaesthetist with clinical responsibility for the patient thought would make the study intervention clinically unacceptable.
- unsatisfactory preoperative peripheral arterial oxygen saturation.
- Unsatisfactory preoperative hemoglobin level.
- Neurological or psychiatric disease.
Trial locations and contacts
1 site in 1 country.
wesam A Nashat contact
Egypt1 site, 1 recruiting
- Recruiting
Wael
Asyut, Asyut Governorate, 11711
Wael m abdelrady, 01006805857, marwarady-2012@hotmail.com
About this study
the Investigators aim to study the effect of fentanyl with topical levobupivacaine with nasal packing in endoscopic nasal surgery
- Being tested
- Fentanyl + Topical Levobupivacaine, levobupivacaine
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Fentanyl + Topical LevobupivacaineDrug
in nasal packing
levobupivacaineDrug
in nasal packing
| Study group | Role | What they receive |
|---|---|---|
| saline | No intervention | saline for pain for nasal packing |
| levobupivacaine | Active comparator | levobupivacaine for pain of nasal packing Receives: Drug: levobupivacaine |
| fentanyl +levobupivacaine | Active comparator | fentanyle with levobupivacaine for pain of nasal packing Receives: Drug: Fentanyl + Topical Levobupivacaine |
What is being measured
The primary outcome is the main question the study is designed to answer.
postoperative pain by visual analoge score
assessment of pain on removal of nasal packing after endoscopic nasal surgery by VAS score. The Visual Analogue Scale (VAS) (0, no discomfort and no pain; 10, a high level of discomfort and maximum pain)
Measured: 24 houres postoperative pain assessment
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted1 Jun 2020
- Study start20 Jun 2020
- Primary completion1 Jul 2021
- Study completionAug 2021 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Analgesia During Removal of Nasal Pack After Nasal SurgeryStudies 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
- Randomised
- Intervention model
- Parallel groups
- Masking
- Quadruple blind
- Who is masked
- Participant, Care provider, Investigator, Outcomes assessor
- Enrolment
- 75 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Assiut University
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Marwa mahmoud Abd El Rady, Assiut University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT04410588
- Sponsor's protocol ID
- marwawael
- Acronym
- fentanyl
- Status last verified
- Jul 2021
- First submitted
- 20 May 2020
- Last updated
- 20 Aug 2021
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- Yes
Study at a glance
From the registry record, last updated by the sponsor on 20 Aug 2021. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Effect of Fentanyl With Topical Levobupivacaine With Nasal Packing in Endoscopic Nasal Surgery
- ClinicalTrials.gov ID
- NCT04410588
- Acronym / sponsor ID
- fentanyl / marwawael
- Phase
- Phase 2
- Study type
- Interventional
- Recruitment status
- Unknown status
- Enrolment
- 75 participants (estimated)
- Lead sponsor
- Assiut UniversityUniversity, hospital or other
- Study start
- 20 Jun 2020 (actual)
- Primary completion
- 1 Jul 2021 (actual)
- Study completion
- Aug 2021 (estimated)
- First posted
- 1 Jun 2020 (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.
the Investigators aim to study the effect of fentanyl with topical levobupivacaine with nasal packing in endoscopic nasal surgery
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Quadruple blind (participant, care provider, investigator, outcomes assessor)
- Number of arms
- 3
| Arm | Type | Receives |
|---|---|---|
| saline | No intervention | –saline for pain for nasal packing |
| levobupivacaine | Active comparator | Drug: levobupivacainelevobupivacaine for pain of nasal packing |
| fentanyl +levobupivacaine | Active comparator | Drug: Fentanyl + Topical Levobupivacainefentanyle with levobupivacaine for pain of nasal packing |
Who may qualify
- Ages
- 18 to 60 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult
Key inclusion criteria (0 listed)
Key exclusion criteria (4 listed)
- Patients will also be excluded if any perioperative cardiovascular or respiratory event occurred which the anaesthetist with clinical responsibility for the patient thought would make the study intervention clinically unacceptable.
- unsatisfactory preoperative peripheral arterial oxygen saturation.
- Unsatisfactory preoperative hemoglobin level.
- Neurological or psychiatric disease.
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 |
|---|---|---|
| Fentanyl + Topical Levobupivacainein nasal packing | Drug | fentanyl +levobupivacaine |
| levobupivacainein nasal packing | Drug | levobupivacaine |
Primary outcome
postoperative pain by visual analoge score
Time frame: 24 houres postoperative pain assessment
assessment of pain on removal of nasal packing after endoscopic nasal surgery by VAS score. The Visual Analogue Scale (VAS) (0, no discomfort and no pain; 10, a high level of discomfort and maximum pain)
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 20 Aug 2021.
- Individual participant dataSharing planned: Yes
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.
wesam A Nashat contact
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 2 study testing Fentanyl + Topical Levobupivacaine and levobupivacaine in people with Analgesia During Removal of Nasal Pack After Nasal Surgery, run by Assiut University at 1 site in Egypt.
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 0 inclusion and 4 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 20 Aug 2021. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Egypt. Whether a site is taking part right now should be confirmed with that site. See every site.
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 Marwa M Abdelrady (01006805857, marwarady-2012@hotmail.com), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
postoperative pain by visual analoge score (time frame: 24 houres postoperative pain assessment). 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 20 Aug 2021.