Use of Vibration Anesthesia Device in Intratympanic Injections

NCT06885723 | Completed

• 1 other identifier: Desicion No:03 Date:17.06.2020
• Study Type: interventional
• Target: 40
• Locations: 1 country
• Sites: 1

Brief Summary

SUMMARY Intratympanic injections commonly cause pain in the patients. Intratympanic steroid injection (ITS) application can be performed by direct injection without anesthesia or with local anesthesia induced by lidocaine spray, lidocaine injection, topical phenol, pantocaine, EMLA cream (lidocaine+prilocaine) or vibration anesthesia device (VAD). The advantage of VAD application over other anesthetic agents was that it eliminated the need to use local anesthetics that may disrupt wound healing. In addition, inducing anesthesia with VAD can be considered as an alternative method in patients allergic to drugs.

Conditions

Intratympanic Injections; Sudden Hearing Loss

Keywords

sensorineural hearing loss; VAD; intratympanic steroid; pain; Sudden hearing loss

Outcome Measures

Primary Outcomes (3)

• Visual Analogue Scale(VAS)

  Visual Analogue Scale (VAS). the visual analog scale (VAS) scaled between 0-10,were used.

  56 weeks

• Eleven-Point Numeric Rating Scale(NRS-11)

  Eleven-Point Numeric Rating Scale (NRS-11). the numerical rating scale (NRS) scaled between 0-10 were used.

  56 weeks

• Four-Category Verbal Rating Scale(VRS-4)

  Four-Category Verbal Rating Scale (VRS-4). the verbal rating scale (VRS) scaled between 0-4 were used.

  56 weeks

Study Arms (4)

1.group

EXPERIMENTAL

Prior to each ITS, all the four methods including local anesthetic cream (EMLA® cream, AstraZeneca PLC), lidocaine spray (Vemcain® Spray), VAD (Blaine®, Blaine Labs, Santa Fe, USA), and saline drops (control) were administered in each patient. The order of administration was determined for each patient using the randomization software (random.org/lists/). For the fifth ITS, however, the method of administration was selected by the patient. After each ITS, pain assessment was performed using Visual Analogue Scale (VAS), Numerical Rating Scales (NRS), and Verbal Rating Scales (VRS)

Device: Vibration Anesthesia Device (VAD)

2.group

ACTIVE COMPARATOR

Prior to each ITS, all the four methods including local anesthetic cream (EMLA® cream, AstraZeneca PLC), lidocaine spray (Vemcain® Spray), VAD (Blaine®, Blaine Labs, Santa Fe, USA), and saline drops (control) were administered in each patient. The order of administration was determined for each patient using the randomization software (random.org/lists/). For the fifth ITS, however, the method of administration was selected by the patient.

Drug: local anesthetic cream

3.group

ACTIVE COMPARATOR

Prior to each ITS, all the four methods including local anesthetic cream (EMLA® cream, AstraZeneca PLC), lidocaine spray (Vemcain® Spray), VAD (Blaine®, Blaine Labs, Santa Fe, USA), and saline drops (control) were administered in each patient. The order of administration was determined for each patient using the randomization software (random.org/lists/). For the fifth ITS, however, the method of administration was selected by the patient.

Drug: lidocaine spray

4.group

PLACEBO COMPARATOR

Prior to each ITS, all the four methods including local anesthetic cream (EMLA® cream, AstraZeneca PLC), lidocaine spray (Vemcain® Spray), VAD (Blaine®, Blaine Labs, Santa Fe, USA), and saline drops (control) were administered in each patient. The order of administration was determined for each patient using the randomization software (random.org/lists/). For the fifth ITS, however, the method of administration was selected by the patient.

Other: saline drops

Interventions

Vibration Anesthesia Device (VAD) DEVICE

In conclusion, induction of anesthesia with VAD in patients treated with ITS provided pain palliation in a similar way to other local anesthetic techniques. Moreover, the advantage of VAD application over other anesthetic agents was that it eliminated the need to use local anesthetics that may disrupt wound healing. In addition, inducing anesthesia with VAD can be considered as an alternative method in patients allergic to drugs. Our study will shed light on different techniques such as the application of ventilation tube in anesthesia with VAD.

1.group

local anesthetic cream DRUG

Prior to each ITS, all the four methods including local anesthetic cream (EMLA® cream, AstraZeneca PLC), lidocaine spray (Vemcain® Spray), VAD (Blaine®, Blaine Labs, Santa Fe, USA), and saline drops (control) were administered in each patient. The order of administration was determined for each patient using the randomization software (random.org/lists/). For the fifth ITS, however, the method of administration was selected by the patient.

2.group

lidocaine spray DRUG

Prior to each ITS, all the four methods including local anesthetic cream (EMLA® cream, AstraZeneca PLC), lidocaine spray (Vemcain® Spray), VAD (Blaine®, Blaine Labs, Santa Fe, USA), and saline drops (control) were administered in each patient. The order of administration was determined for each patient using the randomization software (random.org/lists/). For the fifth ITS, however, the method of administration was selected by the patient.

3.group

saline drops OTHER

Prior to each ITS, all the four methods including local anesthetic cream (EMLA® cream, AstraZeneca PLC), lidocaine spray (Vemcain® Spray), VAD (Blaine®, Blaine Labs, Santa Fe, USA), and saline drops (control) were administered in each patient. The order of administration was determined for each patient using the randomization software (random.org/lists/). For the fifth ITS, however, the method of administration was selected by the patient.

4.group

Eligibility Criteria

• Age: 18 Years - 70 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• Aged 18-70 years with idiopathic sudden sensorineural hearing loss

You may not qualify if:

• History of otologic surgery,
• Recent ototoxic drug use,
• Congenital inner ear malformation,
• History of chemoradiotherapy due to malignant neoplasia,
• Presence of acute or chronic otitis media,
• Age under 18 years, over 70 years
• History of local anesthesia allergy,
• Coagulation abnormality,
• Pregnant and lactating women,
• Hearing cases with other neurootological diseases

Sponsors & Collaborators

• Yuzuncu Yil University: lead

Study Sites (1)

van yuzuncu yil university, Bardakçı, Yüzüncü Yıl Ünv., 65080 Tuşba/Van

Van, 65000, Turkey (Türkiye)

Location

MeSH Terms

Conditions

Hearing Loss, Sudden; Hearing Loss, Sensorineural; Pain

Condition Hierarchy (Ancestors)

Hearing Loss; Hearing Disorders; Ear Diseases; Otorhinolaryngologic Diseases; Sensation Disorders; Neurologic Manifestations; Nervous System Diseases; Signs and Symptoms; Pathological Conditions, Signs and Symptoms

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: SINGLE
• Who Masked: PARTICIPANT
• Purpose: HEALTH SERVICES RESEARCH
• Intervention Model: CROSSOVER
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: MEDİCAL DOCTOR

Model Details: Prior to each intratimpanik steroid injection (ITS), all the four methods including local anesthetic cream (EMLA® cream, AstraZeneca PLC), lidocaine spray (Vemcain® Spray), VAD (Blaine®, Blaine Labs, Santa Fe, USA), and saline drops (control) were administered in each patient. The order of administration was determined for each patient using the randomization software (random.org/lists/). For the fifth ITS, however, the method of administration was selected by the patient. After each ITS, pain assessment was performed using Visual Analogue Scale , Numerical Rating Scales, and Verbal Rating Scales

Study Record Dates

• First Submitted: December 23, 2024
• First Posted: March 20, 2025
• Study Start: July 25, 2020
• Primary Completion: August 25, 2021
• Study Completion: December 25, 2021
• Last Updated: March 20, 2025

Record last verified: 2025-03

Locations

TU (1)