The Effect of Topical Vibration on Injection Pain in Scalp Block

Study Overview
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Brief Summary
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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.

Detailed Description
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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.

Official Title
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The Effect of Topical Vibration on Injection Pain in Scalp Block

Conditions
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Analgesia

Intervention / Treatment
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* Device: topical vibration


Participation Criteria
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Eligibility Criteria
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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

Ages Eligible for Study
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Minimum Age: 18 Years
Maximum Age: 80 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Supportive Care
Allocation: Non-Randomized
Intervention Model: Crossover Assignment
Masking: None (Open Label)


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Active Comparator: topical vibration<br>For all patients one half of the scalp was injected with vibration device. | Device: topical vibration<br>* topical vibration (Aprilla brand, giving 6000 vibrations per minute) is a device for pain relief during injection of local anesthetic.<br>|
| No Intervention: control<br>Same patient's other side of the scalp was injected without vibration device. | |

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| pain score (NRS) | 0 ; no pain,10; the worst pain ever possible | during needling (injection) procedure | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Mean arterial pressure (mmHg) |  | baseline, during needling procedure, 1 min after needling | 
| Heart Rate (beat/min) |  | baseline, during needling procedure, 1 min after needling | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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scalp clock, awake craniotomy, vibration