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The Effect of Topical Vibration on Injection Pain in Scalp Block

D

Diskapi Teaching and Research Hospital

Status

Completed

Conditions

Analgesia

Treatments

Device: topical vibration

Study type

Interventional

Funder types

Other

Identifiers

NCT06038825
scalp block

Details and patient eligibility

About

In this study; it's aimed to reduce injection pain during the practice of scalp block, which is used as a method of anesthesia in patients who underwent awake craniotomy surgery. For this purpose, the investigators used topical vibration stimulation, which is non-invasive procedure.

Full description

Scalp block is an analgesia technique frequently used in neurosurgical procedures. In this block, while providing adequate anesthesia for surgery, it also helps to preserve hemodynamics by inhibiting pain sensation. In this block, there is a certain degree of pain due to multiple injections. The transmission of pain sensation to the cortex is reduced by costimulating the receptors that transmit the pain sensation with vibration stimulus. In this study; it was aimed to investigate the effect of topical vibration on injection pain in participants who received sedoanalgesia with dexmedetomidine in bilateral scalp block practice.

In routine clinical practice, bilateral scalp block (local anesthetic injection into greater occipital, lesser occipital, supratrochlear, supraorbital, auriculotemporal, zygomaticotemporal nerves) is performed in participants who is sedated. While local anesthetic is injecting, vibration device (Aprilla brand, giving 6000 vibrations per minute) will be vibrated for 10 seconds and then local anesthetic will be injected. Meanwhile, participants' numerical pain scores (NRS) and hemodynamic parameters will be monitored.

In this study, the NRS scores and hemodynamic variables of the participants will be compared during the local anesthetic application of each 6 nerves bilaterally and during the injections of the nerves with and without the use of vibration.

Enrollment

56 patients

Sex

All

Ages

18 to 80 years old

Volunteers

No Healthy Volunteers

Inclusion criteria

  • between the ages of 18-75
  • ASA (American Society of Anesthesiologists) Scoring I-III
  • Cases in which scalp block will be applied

Exclusion criteria

  • ASA score IV

    • Uncooperative
    • Known allergy to any of the study drugs

Trial design

Primary purpose

Supportive Care

Allocation

Non-Randomized

Interventional model

Crossover Assignment

Masking

None (Open label)

56 participants in 2 patient groups

topical vibration
Active Comparator group
Description:
For all patients one half of the scalp was injected with vibration device.
Treatment:
Device: topical vibration
control
No Intervention group
Description:
Same patient's other side of the scalp was injected without vibration device.

Trial contacts and locations

1

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Central trial contact

Derya Ozkan, professor

Data sourced from clinicaltrials.gov

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