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

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

Study Overview

• Status: Unknown
• Conditions: Analgesia; Epistaxis
• Intervention / Treatment: Drug: Xylocaine Mucosal Product; Drug: Placebo

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.

• Study Type: Interventional
• Enrollment (Anticipated): 60
• Phase: Early Phase 1

Contacts and Locations

• Study Contact: Name: Muhamed Masalha, MD; Phone Number: +972-54-635-5305; Email: masalha.muhamed@gmail.com

Study Locations

• Israel
  • Afula, Israel
    • Emek Medical Center
    • Contact: Muhamed Masalha, MD; Phone Number: +972-54-635-5305; Email: masalha.muhamed@gmail.com

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 18 years and older (Adult, Older Adult)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: All

Description

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

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Treatment
• Allocation: Randomized
• Interventional Model: Parallel Assignment
• Masking: Double

Number of Arms

2

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Experimental: Xylocaine; 30 patients who receive Xylocaine 10% nasal spray	Drug: Xylocaine Mucosal Product; Xylocaine 10% Nasal Spray
Placebo Comparator: Saline; 30 patients who receive saline nasal spray	Drug: Placebo; Sodium Chloride 0.9%

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Visual Analogue Scale (VAS)	Visual Analogue Scale (VAS) ranging from 0- no pain at all to 10 - unbearable pain.	Immediately after the procedure

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
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.	Immediately after the procedure

Collaborators and Investigators

• Sponsor: Muhamed Masalha
• Investigators: Principal Investigator: Muhamed Masalha, MD, Emek Medical Center, Afula, Israel.

Publications and helpful links

General Publications

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

Helpful Links

• Lidocaine Drug Information

Study record dates

Study Major Dates

• Study Start (Anticipated): September 1, 2020
• Primary Completion (Anticipated): September 1, 2022
• Study Completion (Anticipated): December 1, 2022

Study Registration Dates

• First Submitted: August 6, 2020
• First Submitted That Met QC Criteria: August 18, 2020
• First Posted (Actual): August 19, 2020

Study Record Updates

• Last Update Posted (Actual): August 19, 2020
• Last Update Submitted That Met QC Criteria: August 18, 2020
• Last Verified: August 1, 2020

More Information

Terms related to this study

• Keywords: Nasal Spray; Epistaxis; Nasal Anesthesia
• Additional Relevant MeSH Terms: Pathologic Processes; Respiratory Tract Diseases; Hemorrhage; Otorhinolaryngologic Diseases; Signs and Symptoms, Respiratory; Nose Diseases; Epistaxis; Physiological Effects of Drugs; Molecular Mechanisms of Pharmacological Action; Anti-Arrhythmia Agents; Central Nervous System Depressants; Peripheral Nervous System Agents; Sensory System Agents; Anesthetics; Membrane Transport Modulators; Anesthetics, Local; Voltage-Gated Sodium Channel Blockers; Sodium Channel Blockers; Lidocaine
• Other Study ID Numbers: 0081-20-EMC

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: No

Drug and device information, study documents

• 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