search
Back to results

The Effect of Local Anesthesia With Lidocaine During Insertion and Removal of Nasal Packing

Primary Purpose

Epistaxis, Analgesia

Status
Unknown status
Phase
Early Phase 1
Locations
Israel
Study Type
Interventional
Intervention
Xylocaine Mucosal Product
Placebo
Sponsored by
Muhamed Masalha
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Epistaxis focused on measuring Nasal Spray, Nasal Anesthesia, Epistaxis

Eligibility Criteria

18 Years - undefined (Adult, Older Adult)All SexesAccepts Healthy Volunteers

Inclusion Criteria:

  • 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.

Exclusion Criteria:

  • 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

Sites / Locations

  • Emek Medical Center

Arms of the Study

Arm 1

Arm 2

Arm Type

Experimental

Placebo Comparator

Arm Label

Xylocaine

Saline

Arm Description

30 patients who receive Xylocaine 10% nasal spray

30 patients who receive saline nasal spray

Outcomes

Primary Outcome Measures

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

Secondary Outcome Measures

Patient Questionnaires
Patient symptoms: nausea, vomiting, allergic reaction, localized pain, numbness in the pharynx, bitter taste, dysphagia. For any side effect, the duration until the symptoms had passed. Scale of symptoms severity ranging from 0- no symptoms at all to 10 - worst symptoms severity.

Full Information

First Posted
August 6, 2020
Last Updated
August 18, 2020
Sponsor
Muhamed Masalha
search

1. Study Identification

Unique Protocol Identification Number
NCT04519463
Brief Title
The Effect of Local Anesthesia With Lidocaine During Insertion and Removal of Nasal Packing
Official Title
The Effect of Local Anesthesia With Lidocaine During Insertion and Removal of Nasal Packing
Study Type
Interventional

2. Study Status

Record Verification Date
August 2020
Overall Recruitment Status
Unknown status
Study Start Date
September 2020 (Anticipated)
Primary Completion Date
September 2022 (Anticipated)
Study Completion Date
December 2022 (Anticipated)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Sponsor-Investigator
Name of the Sponsor
Muhamed Masalha

4. Oversight

Studies a U.S. FDA-regulated Drug Product
Yes
Studies a U.S. FDA-regulated Device Product
No
Product Manufactured in and Exported from the U.S.
Yes
Data Monitoring Committee
No

5. Study Description

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.
Detailed Description
Nasal packing has many uses, such as prevention of postoperative bleeding following endoscopic sinus surgery, stabilization of the nasal septum, prevention of adhesions following septoplasty, and treatment of active epistaxis1,2. The utilization of tampons for nasal packing during nasal and sinus surgeries is widely used and safe. Nasal tampons assist in creating a moist supportive environment for tissue healing without causing local irritation or foreign body reaction3. The removal is performed after 24-48 hours. On the other hand, there are some disadvantages to the uses of nasal tampons: trauma to the nasal mucosa, infection of the nose and sinuses, aspiration of part of the tampon, and even toxic shock syndrome3. One of the most troublesome aspects to the patient and the clinician is the pain and discomfort during insertion and removal of the tampons3,4. In our experience, these symptoms are of considerable significance to the patient experience and satisfaction. There is a wide range of commercially available nasal packings such as Merocel and Nasopore. In our practice, Merocel nasal tampons are used, which contain polyvinyl acetate. This type of material expands upon contact with fluids, and it is not soluble. This product is used at the end of endoscopic nasal surgeries and in the treatment of active epistaxis, not amenable to local pressure and without a recognizable source of bleeding. In case of unstoppable bleeding despite the use of nasal tampons, a nasal balloon is inflated in the nasal cavity. Its insertion and inflation are associated with patient pain and discomfort. Lidocaine is a drug commonly used for local anesthesia. It is used for local nasal anesthesia by a variety of commercially available sprays, atomizers, nebulizers, gels, and ointments. Lidocaine causes local anesthesia by affecting sodium channels, causing decreased initiation and conduction of neural impulses. In turn, fewer afferent impulses reach the central nervous system6. In healthy individuals, side effects are negligible, but it could influence patients with cardiac infarction. The main side effects of lidocaine are neurological, which could be of significance in the case of inflamed or damaged tissue because of rapid absorption. The use of Lidocaine spray (Xylocaine 10%) is commonly available worldwide and is routinely used in our institution before fiberoptic laryngoscopy. Previous publications have mentioned the positive effect of local anesthesia during the removal of nasal tampons5,7. In a recent meta-analysis, local anesthetics were associated with less pain during the removal of nasal tampons and shortened time of the procedure. Yet, the authors recognized the need for additional randomized controlled trials7. There are no previous publications on the effect of local anesthetics on the insertions of nasal tampons during active nasal bleeding. In the experience of the senior author, for many years, the application of lidocaine spray 10% before the insertions of nasal tampons for epistaxis was associated with a significant reduction of pain and discomfort. This study aims to investigate the effect of local nasal anesthesia with lidocaine spray on the insertion of nasal tampons during active nasal bleeding. Secondary objectives include the impact on nasal tampons removal after the cessation of nasal bleeding and after endoscopic sinus surgery. Research hypothesis: local anesthesia with lidocaine before the insertion of nasal tampons or inflatable balloon reduces patients' pain, discomfort, and stress during insertion for the treatment of active nasal bleeding, and during removal of nasal tampons either postoperatively or after cessation of epistaxis. The study population involves 30 patients with spontaneous epistaxis and another 30 patients who went tampon removal postoperatively in our institution. Recruitment includes patients who came to the emergency department with active epistaxis and still had active bleeding after the application of local pressure without an identified source of bleeding, requiring treatment with tampons or an inflatable balloon. The second group included patients who require postoperative removal of nasal tampons.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Epistaxis, Analgesia
Keywords
Nasal Spray, Nasal Anesthesia, Epistaxis

7. Study Design

Primary Purpose
Treatment
Study Phase
Early Phase 1
Interventional Study Model
Parallel Assignment
Model Description
Double-Blind Randomized Controlled Trial
Masking
ParticipantInvestigator
Masking Description
Both Xylocaine spray and Placebo (saline) will be in similar containers with serial numbers, Both clinician and patient are blinded to the content.
Allocation
Randomized
Enrollment
60 (Anticipated)

8. Arms, Groups, and Interventions

Arm Title
Xylocaine
Arm Type
Experimental
Arm Description
30 patients who receive Xylocaine 10% nasal spray
Arm Title
Saline
Arm Type
Placebo Comparator
Arm Description
30 patients who receive saline nasal spray
Intervention Type
Drug
Intervention Name(s)
Xylocaine Mucosal Product
Intervention Description
Xylocaine 10% Nasal Spray
Intervention Type
Drug
Intervention Name(s)
Placebo
Intervention Description
Sodium Chloride 0.9%
Primary Outcome Measure Information:
Title
Visual Analogue Scale (VAS)
Description
Visual Analogue Scale (VAS) ranging from 0- no pain at all to 10 - unbearable pain.
Time Frame
Immediately after the procedure
Secondary Outcome Measure Information:
Title
Patient Questionnaires
Description
Patient symptoms: nausea, vomiting, allergic reaction, localized pain, numbness in the pharynx, bitter taste, dysphagia. For any side effect, the duration until the symptoms had passed. Scale of symptoms severity ranging from 0- no symptoms at all to 10 - worst symptoms severity.
Time Frame
Immediately after the procedure

10. Eligibility

Sex
All
Minimum Age & Unit of Time
18 Years
Accepts Healthy Volunteers
Accepts Healthy Volunteers
Eligibility Criteria
Inclusion Criteria: 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. Exclusion Criteria: 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
Central Contact Person:
First Name & Middle Initial & Last Name or Official Title & Degree
Muhamed Masalha, MD
Phone
+972-54-635-5305
Email
masalha.muhamed@gmail.com
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Muhamed Masalha, MD
Organizational Affiliation
Emek Medical Center, Afula, Israel.
Official's Role
Principal Investigator
Facility Information:
Facility Name
Emek Medical Center
City
Afula
Country
Israel
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Muhamed Masalha, MD
Phone
+972-54-635-5305
Email
masalha.muhamed@gmail.com

12. IPD Sharing Statement

Plan to Share IPD
No
Citations:
PubMed Identifier
2781213
Citation
Watson MG, Campbell JB, Shenoi PM. Nasal surgery: does the type of nasal pack influence the results? Rhinology. 1989 Jun;27(2):105-11.
Results Reference
background
PubMed Identifier
11562881
Citation
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.
Results Reference
background
PubMed Identifier
26511988
Citation
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.
Results Reference
background
PubMed Identifier
18085028
Citation
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.
Results Reference
background
PubMed Identifier
32127341
Citation
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.
Results Reference
background
Links:
URL
https://www.hamichlol.org.il/%D7%9C%D7%99%D7%93%D7%95%D7%A7%D7%90%D7%99%D7%9F
Description
Lidocaine Drug Information

Learn more about this trial

The Effect of Local Anesthesia With Lidocaine During Insertion and Removal of Nasal Packing

We'll reach out to this number within 24 hrs