Use of Vibration Anesthesia Device in Intratympanic Injections

Not Applicable

Completed

• Conditions: Intratympanic Injections; Sudden Hearing Loss
• Interventions: Device: Vibration Anesthesia Device (VAD); Drug: local anesthetic cream; Drug: lidocaine spray; Other: saline drops

• Registration Number: NCT06885723
• Lead Sponsor: Yuzuncu Yıl University

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.

Detailed Description

ABSTRACT In this study, we aimed to compare the efficacy of four methods including topical lidocaine spray, local anesthetic cream, vibration anesthesia device (VAD), and saline drops (control group) in the reduction of pain after intratympanic steroid injections (ITS's) and to demonstrate the effectiveness of VAD use. The prospective study included 40 patients aged 18-70 years with idiopathic sudden sensorineural hearing loss. 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. After each ITS, pain assessment was performed using Visual Analogue Scale (VAS), Numerical Rating Scales (NRS), and Verbal Rating Scales (VRS).

Study Timeline

• Study Start: 2020-07-25
• Primary Completion: 2021-08-25
• Study Completion: 2021-12-25
• Study First Submitted: 2024-12-23
• Status Verified: 2025-03
• Study First Submitted QC: 2025-03-19
• Last Update Submitted: 2025-03-19
• Study First Posted: 2025-03-20
• Last Update Posted: 2025-03-20

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 40

Inclusion Criteria

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

Exclusion Criteria

• 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

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: CROSSOVER

Arm && Interventions

Group	Intervention	Description
1.group	Vibration Anesthesia Device (VAD)	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)
2.group	local anesthetic cream	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	lidocaine spray	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	saline drops	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.

Primary Outcome Measures

Name	Time	Method
Visual Analogue Scale(VAS)	56 weeks	Visual Analogue Scale (VAS). the visual analog scale (VAS) scaled between 0-10,were used.
Eleven-Point Numeric Rating Scale(NRS-11)	56 weeks	Eleven-Point Numeric Rating Scale (NRS-11). the numerical rating scale (NRS) scaled between 0-10 were used.
Four-Category Verbal Rating Scale(VRS-4)	56 weeks	Four-Category Verbal Rating Scale (VRS-4). the verbal rating scale (VRS) scaled between 0-4 were used.

Trial Locations

Locations (1)

van yuzuncu yil university, Bardakçı, Yüzüncü Yıl Ünv., 65080 Tuşba/Van; 🇹🇷 VAN, Turkey