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Completed

NCT Number: NCT06885723

Use of Vibration Anesthesia Device in Intratympanic Injections

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.

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Key information

Age range

18 year–70 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

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

Van, 65000, Turkey (Türkiye)

About this study

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).

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

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.

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.

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.

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.

Primary outcomes

  1. Visual Analogue Scale(VAS)

    Time frame: 56 weeks

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

  2. Eleven-Point Numeric Rating Scale(NRS-11)

    Time frame: 56 weeks

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

  3. Four-Category Verbal Rating Scale(VRS-4)

    Time frame: 56 weeks

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

Sponsors and collaborators

Lead sponsor

Yuzuncu Yil University

Other

Registry information

Official study title

Evaluation of Different Anesthesia Methods to Reduce Pain From Intratympanic Injections: A Prospective, Randomized Clinical Trial

Important dates

Study start
2020
Primary completion
2021
Study completion
2021
First posted
Mar 20, 2025
Registry last updated
Mar 20, 2025

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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