Clinical trial NCT06885723: Use of Vibration Anesthesia Device in Intratympanic Injections
Official title: Evaluation of Different Anesthesia Methods to Reduce Pain From Intratympanic Injections: A Prospective, Randomized Clinical Trial
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Intratympanic Injections
Sudden Hearing Loss
Keywords: sensorineural hearing loss
VAD
intratympanic steroid
pain
Sudden hearing loss
Lead sponsor: Yuzuncu Yıl University
Sponsor class: OTHER
First posted: 2025-03-20
Enrollment: 40
Sex: ALL
Minimum age (years): 18
Maximum age (years): 70
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: CROSSOVER
Intervention model description: 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
Primary purpose: HEALTH_SERVICES_RESEARCH

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).

Eligibility criteria: 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

Primary outcomes:
measure: Visual Analogue Scale(VAS)
timeFrame: 56 weeks
measure: Eleven-Point Numeric Rating Scale(NRS-11)
timeFrame: 56 weeks
measure: Four-Category Verbal Rating Scale(VRS-4)
timeFrame: 56 weeks
Secondary outcomes:
Other outcomes:
Locations:
city: VAN
country: Turkey
facility: van yuzuncu yil university, Bardakçı, Yüzüncü Yıl Ünv., 65080 Tuşba/Van
Study officials:
References: