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AzTrials

Endoscopic Sinus SurgeryPhase 2/3NCT05145543

Effect of Topically Administered Levobupivacaine- Fentanyl Versus Levobupivacaine- Dexamethasone Combination in the Control of Pain After Endoscopic Sinus Surgery

A Phase 2/3 study testing Saline 0.9%, Levobupivacaine Hydrochloride and Fentanyl in people with Endoscopic Sinus Surgery and Fentanyl, run by Assiut University at 1 site in Egypt.

Unknown status

Status not confirmed. The sponsor has not verified this record for over two years, so it may be out of date.

Official record
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Trial summary

Chronic sinusitis (CRS) is a high incidence disease characterized by pus, nasal obstruction, olfactory disturbance, headache, and other symptoms, lasting for more than 12 weeks, with severe cases having ocular compression and visual impairment, which can cause cranial, eye, and lung complications. Read more about this study

Who is it for?
Ages 18 to 65 years
Conditions the study is for
Endoscopic Sinus Surgery, Fentanyl
What is being tested?
Saline 0.9%, Levobupivacaine Hydrochloride and Fentanyl
Could I receive a placebo?
Yes, some participants may receive a placebo
How many people
80 participants
Where
1 siteEgypt
Study dates
1 Dec 2021to Mar 2022
Phase
Phase 2/3
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 65 years
  • All sexes
  • No healthy volunteers
  • Adult, Older adult

Who may be able to join

  • • ASA physical status I-II patients
  • scheduled for elective FESS surgery. • Age from 18 to 65 years patients

Who cannot join

  • • Age>18 and<65 years patients,
  • Previous history of FESS,
  • Patients with sensitivity to anesthetic agents in the study,
  • Patients who will do additional septoplasty or turbinate surgery,
  • Patients with disturbance of blood coagulation, including pro¬thrombin time (PT)/partial thromboplastin time (PTT) prolon¬gation, purpura, and spontaneous bleeding;

Trial locations and contacts

1 site in 1 country.

Ghada Abo Elfadl, MD contact

01005802086

ghadafadl77@gmail.com

Egypt1 site, 1 recruiting

  • Assiut governorate

    Asyut, 715715

    Ghada M Aboelfadl, MD, 01005802086, ghadafadl77@gmail.com

    Recruiting

Other trials in Egypt

About this study

Official title: Effect of Topically Administered Levobupivacaine- Fentanyl Versus Levobupivacaine- Dexamethasone Combination in the Control of Pain After Endoscopic Sinus Surgery: A Randomized Controlled Trial

Chronic sinusitis (CRS) is a high incidence disease characterized by pus, nasal obstruction, olfactory disturbance, headache, and other symptoms, lasting for more than 12 weeks, with severe cases having ocular compression and visual impairment, which can cause cranial, eye, and lung complications. Chronic sinusitis is a high-risk disease.

Read the detailed description

One of the main concerns about using packing is that the removal is usually very painful and can be very bothersome. This procedure may even result in syncope by the activation of the vasovagal reflex system. There have been a few studies suggesting that nasal packs should not be used because removal from the nose causes serious discomfort and is painful. Many patients who have undergone nasal surgery report that the removal of the pack was the most painful part of the experience.

Postoperative pain is an acute inflammatory pain that starts with surgical trauma and ends with tissue healing. It can be harmful to organ systems by initiating inflamma¬tion through different mechanisms, and the alleviation of postoperative pain is considered important for obtaining homeostasis. Pain may initiate atelectasis due to improper coughing, immobilization may cause thromboembolism and catecholamine discharge may induce cardiovascular side effects and undesired changes in neuroendocrine or meta¬bolic function

Being tested
Saline 0.9%, Levobupivacaine Hydrochloride, Fentanyl, Dexamethasone
Keywords
dexamethasone, Levobupivacaine

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

  • Saline 0.9%Drug

    0.9 NaCl % (Saline) (5 ml) will be applied

  • Levobupivacaine HydrochlorideDrug

    0.25 % levobupivacaine (5 ml) will be applied.

  • FentanylDrug

    fentanyl plus 0.25 % levobupivacaine (5 ml) will be applied.

  • DexamethasoneDrug

    Dexamethasone plus levobupivacaine (5 ml) will be applied.

Study groups in NCT05145543
Study groupRoleWhat they receive
Group CPlacebo comparator0.9 NaCl % (Saline) (5 ml)
Receives: Drug: Saline 0.9%
Group LActive comparator0.25 % levobupivacaine (5 ml) will be applied.
Receives: Drug: Levobupivacaine Hydrochloride
Group LFExperimentalfentanyl plus 0.25 % levobupivacaine (5 ml) will be applied.
Receives: Drug: Levobupivacaine Hydrochloride; Drug: Fentanyl
Group LDExperimentaldexamethasone plus levobupivacaine (5 ml) will be applied.
Receives: Drug: Levobupivacaine Hydrochloride; Drug: Dexamethasone

What is being measured

The primary outcome is the main question the study is designed to answer.

  1. time to first post-operative analgesic request

    when patient require analgesia

    Measured: 24 hours postoperative

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

  1. First posted6 Dec 2021
  2. Study start1 Dec 2021 (estimated)
  3. Primary completionMar 2022 (estimated)
  4. Study completionMar 2022 (estimated)

Resources

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 2/3
Primary purpose
Prevention
Allocation
Randomised
Intervention model
Parallel groups
Masking
Quadruple blind
Who is masked
Participant, Care provider, Investigator, Outcomes assessor
Enrolment
80 participants (estimated)
IDs, dates and publications
ClinicalTrials.gov ID
NCT05145543
Sponsor's protocol ID
17300428
Status last verified
Nov 2021
First submitted
26 Nov 2021
Last updated
6 Dec 2021
Results posted
No
Data monitoring committee
No
FDA-regulated drug
No
FDA-regulated device
No
Individual data sharing
Undecided

Publications

  • Krings JG, Kallogjeri D, Wineland A, Nepple KG, Piccirillo JF, Getz AE. Complications of primary and revision functional endoscopic sinus surgery for chronic rhinosinusitis. Laryngoscope. 2014 Apr;124(4):838-45. doi: 10.1002/lary.24401. Epub 2013 Oct 9.

    PubMed 24122737

  • Chaaban MR, Rana N, Baillargeon J, Baillargeon G, Resto V, Kuo YF. Outcomes and Complications of Balloon and Conventional Functional Endoscopic Sinus Surgery. Am J Rhinol Allergy. 2018 Sep;32(5):388-396. doi: 10.1177/1945892418782248. Epub 2018 Jun 27.

    PubMed 29947260

  • Stankiewicz JA, Lal D, Connor M, Welch K. Complications in endoscopic sinus surgery for chronic rhinosinusitis: a 25-year experience. Laryngoscope. 2011 Dec;121(12):2684-701. doi: 10.1002/lary.21446. Epub 2011 Nov 15.

    PubMed 22086769

Questions about this trial

What is this clinical trial studying?

A Phase 2/3 study testing Saline 0.9%, Levobupivacaine Hydrochloride and Fentanyl in people with Endoscopic Sinus Surgery and Fentanyl, 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 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 6 Dec 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. Some participants in this study may receive a placebo. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.

What does this combined 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.

Phase 3 studies compare the treatment with the current standard treatment or a placebo in a large group, to confirm how well it works and watch for side effects.

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 Ghada Abo Elfadl, MD (01005802086, ghadafadl77@gmail.com), or a site near the patient. AzTrials does not enrol participants or take referrals.

What does the primary outcome measure?

time to first post-operative analgesic request (time frame: 24 hours postoperative). It is what the study was designed to measure, not a finding.

Where can I read the original study information?

On the ClinicalTrials.gov record for NCT05145543, which also lists 3 linked publications.

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 6 Dec 2021.

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