NCT05145543

Brief 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. Chronic sinusitis is a high-risk disease.

Trial Health

43
At Risk

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Trial has exceeded expected completion date
Enrollment
80

participants targeted

Target at P50-P75 for phase_2

Timeline
Completed

Started Dec 2021

Shorter than P25 for phase_2

Geographic Reach
1 country

1 active site

Status
unknown

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

First Submitted

Initial submission to the registry

November 26, 2021

Completed
5 days until next milestone

Study Start

First participant enrolled

December 1, 2021

Completed
5 days until next milestone

First Posted

Study publicly available on registry

December 6, 2021

Completed
3 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

March 1, 2022

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

March 1, 2022

Completed
Last Updated

December 6, 2021

Status Verified

November 1, 2021

Enrollment Period

3 months

First QC Date

November 26, 2021

Last Update Submit

December 3, 2021

Conditions

Endoscopic Sinus SurgeryFentanyl

Keywords

dexamethasoneLevobupivacaine

Outcome Measures

Primary Outcomes (1)

  • time to first post-operative analgesic request

    when patient require analgesia

    24 hours postoperative

Study Arms (4)

Group C

PLACEBO COMPARATOR

0.9 NaCl % (Saline) (5 ml)

Drug: Saline 0.9%

Group L

ACTIVE COMPARATOR

0.25 % levobupivacaine (5 ml) will be applied.

Drug: Levobupivacaine Hydrochloride

Group LF

EXPERIMENTAL

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

Drug: Levobupivacaine HydrochlorideDrug: Fentanyl

Group LD

EXPERIMENTAL

dexamethasone plus levobupivacaine (5 ml) will be applied.

Drug: Levobupivacaine HydrochlorideDrug: Dexamethasone

Interventions

Saline 0.9%DRUG

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

Group C
Levobupivacaine HydrochlorideDRUG

0.25 % levobupivacaine (5 ml) will be applied.

Group LGroup LDGroup LF
FentanylDRUG

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

Group LF
DexamethasoneDRUG

Dexamethasone plus levobupivacaine (5 ml) will be applied.

Group LD

Eligibility Criteria

Age18 Years - 65 Years
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

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

You may not qualify if:

  • 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;

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Assiut governorate

Asyut, 715715, Egypt

RECRUITING

Related Publications (3)

  • 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.

    PMID: 24122737BACKGROUND

  • 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.

    PMID: 29947260BACKGROUND

  • 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.

    PMID: 22086769BACKGROUND

MeSH Terms

Interventions

Sodium ChlorideLevobupivacaineFentanylDexamethasone

Intervention Hierarchy (Ancestors)

ChloridesHydrochloric AcidChlorine CompoundsInorganic ChemicalsSodium CompoundsBupivacaineAnilidesAmidesOrganic ChemicalsAniline CompoundsAminesPiperidinesHeterocyclic Compounds, 1-RingHeterocyclic CompoundsPregnadienetriolsPregnadienesPregnanesSteroidsFused-Ring CompoundsPolycyclic CompoundsSteroids, Fluorinated

Central Study Contacts

Ghada Abo Elfadl, MD

CONTACT

01005802086ghadafadl77@gmail.com

Study Design

Study Type
interventional
Phase
phase 2
Allocation
RANDOMIZED
Masking
QUADRUPLE
Who Masked
PARTICIPANT, CARE PROVIDER, INVESTIGATOR, OUTCOMES ASSESSOR
Purpose
PREVENTION
Intervention Model
PARALLEL
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
Principal investigator

Study Record Dates

First Submitted

November 26, 2021

First Posted

December 6, 2021

Study Start

December 1, 2021

Primary Completion

March 1, 2022

Study Completion

March 1, 2022

Last Updated

December 6, 2021

Record last verified: 2021-11

Locations

EG(1)