NCT04519463

Brief Summary

This study aims to investigate the effect of local nasal anesthesia with lidocaine spray on the insertion of nasal tampons during active nasal bleeding.

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
60

participants targeted

Target at P75+ for early_phase_1

Timeline
Completed

Started Sep 2020

Typical duration for early_phase_1

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

August 6, 2020

Completed
13 days until next milestone

First Posted

Study publicly available on registry

August 19, 2020

Completed
13 days until next milestone

Study Start

First participant enrolled

September 1, 2020

Completed
2 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

September 1, 2022

Completed
3 months until next milestone

Study Completion

Last participant's last visit for all outcomes

December 1, 2022

Completed
Last Updated

August 19, 2020

Status Verified

August 1, 2020

Enrollment Period

2 years

First QC Date

August 6, 2020

Last Update Submit

August 18, 2020

Conditions

EpistaxisAnalgesia

Keywords

Nasal SprayNasal AnesthesiaEpistaxis

Outcome Measures

Primary Outcomes (1)

  • Visual Analogue Scale (VAS)

    Visual Analogue Scale (VAS) ranging from 0- no pain at all to 10 - unbearable pain.

    Immediately after the procedure

Secondary Outcomes (1)

  • Patient Questionnaires

    Immediately after the procedure

Study Arms (2)

Xylocaine

EXPERIMENTAL

30 patients who receive Xylocaine 10% nasal spray

Drug: Xylocaine Mucosal Product

Saline

PLACEBO COMPARATOR

30 patients who receive saline nasal spray

Drug: Placebo

Interventions

Xylocaine Mucosal ProductDRUG

Xylocaine 10% Nasal Spray

Xylocaine
PlaceboDRUG

Sodium Chloride 0.9%

Saline

Eligibility Criteria

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

You may qualify if:

  • Age of 18 years or older
  • Both sexes
  • No known allergy for local anesthetics agents
  • Patients with active nasal bleeding requiring the insertion of a tampon or an inflatable balloon, or patients requiring tampon removal postoperatively.

You may not qualify if:

  • Age under 18 years.
  • Known allergy to local anesthetics
  • Lack of willingness to participate in a clinical trial
  • Patient unable to give informed consent from any reason
  • Pregnancy

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Emek Medical Center

Afula, Israel

Location

Related Publications (5)

  • Watson MG, Campbell JB, Shenoi PM. Nasal surgery: does the type of nasal pack influence the results? Rhinology. 1989 Jun;27(2):105-11.

    PMID: 2781213BACKGROUND

  • Weber R, Keerl R, Hochapfel F, Draf W, Toffel PH. Packing in endonasal surgery. Am J Otolaryngol. 2001 Sep-Oct;22(5):306-20. doi: 10.1053/ajot.2001.26499.

    PMID: 11562881BACKGROUND

  • Haytoglu S, Kuran G, Muluk NB, Arikan OK. Different anesthetic agents-soaked sinus packings on pain management after functional endoscopic sinus surgery: which is the most effective? Eur Arch Otorhinolaryngol. 2016 Jul;273(7):1769-77. doi: 10.1007/s00405-015-3807-2. Epub 2015 Oct 28.

    PMID: 26511988BACKGROUND

  • Karaaslan K, Yilmaz F, Gulcu N, Yigit B, Kocoglu H. The effect of prilocaine and prilocaine plus meperidine infiltration on the pain during nasal packing removal. Rhinology. 2007 Dec;45(4):321-4.

    PMID: 18085028BACKGROUND

  • Tsai SC, Lai MT, Kao YL, Wu CC. Effect of infiltrating nasal packing with local anesthetics in postoperative pain and anxiety following sinonasal surgeries: a systemic review and meta-analysis. Braz J Otorhinolaryngol. 2020 May-Jun;86(3):376-382. doi: 10.1016/j.bjorl.2019.12.011. Epub 2020 Feb 12.

    PMID: 32127341BACKGROUND

Related Links

MeSH Terms

Conditions

EpistaxisAgnosia

Condition Hierarchy (Ancestors)

Nose DiseasesRespiratory Tract DiseasesOtorhinolaryngologic DiseasesHemorrhagePathologic ProcessesPathological Conditions, Signs and SymptomsSigns and Symptoms, RespiratorySigns and SymptomsPerceptual DisordersNeurobehavioral ManifestationsNeurologic ManifestationsNervous System Diseases

Study Officials

  • Muhamed Masalha, MD

    Emek Medical Center, Afula, Israel.

    PRINCIPAL INVESTIGATOR

Central Study Contacts

Muhamed Masalha, MD

CONTACT

+972-54-635-5305masalha.muhamed@gmail.com

Study Design

Study Type
interventional
Phase
early phase 1
Allocation
RANDOMIZED
Masking
DOUBLE
Who Masked
PARTICIPANT, INVESTIGATOR
Masking Details
Both Xylocaine spray and Placebo (saline) will be in similar containers with serial numbers, Both clinician and patient are blinded to the content.
Purpose
TREATMENT
Intervention Model
PARALLEL
Model Details: Double-Blind Randomized Controlled Trial
Sponsor Type
OTHER
Responsible Party
SPONSOR INVESTIGATOR
PI Title
Dr, Muhamed Masalha; Principal Investigator; Senior Surgeon in the Endoscopic Sinus Surgery Unit, the Department of Otolaryngology-Head and neck surgery

Study Record Dates

First Submitted

August 6, 2020

First Posted

August 19, 2020

Study Start

September 1, 2020

Primary Completion

September 1, 2022

Study Completion

December 1, 2022

Last Updated

August 19, 2020

Record last verified: 2020-08

Data Sharing

IPD Sharing
Will not share

Locations

IL(1)