The Effect of Topical Vibration on Injection Pain in Scalp Block

Not Applicable

Completed

• Conditions: Analgesia
• Interventions: Device: topical vibration

• Registration Number: NCT06038825
• Lead Sponsor: Diskapi Teaching and Research Hospital

Brief Summary

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

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.

Study Timeline

• Study Start: 2023-06-01
• Study First Submitted: 2023-08-01
• Study First Submitted QC: 2023-09-14
• Study First Posted: 2023-09-15
• Primary Completion: 2024-01-30
• Study Completion: 2024-02-28
• Status Verified: 2024-05
• Last Update Submitted: 2024-05-15
• Last Update Posted: 2024-05-16

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 56

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

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: CROSSOVER

Arm && Interventions

Group	Intervention	Description
topical vibration	topical vibration	For all patients one half of the scalp was injected with vibration device.

Primary Outcome Measures

Name	Time	Method
pain score (NRS)	during needling (injection) procedure	0 ; no pain,10; the worst pain ever possible

Secondary Outcome Measures

Name	Time	Method
Mean arterial pressure (mmHg)	baseline, during needling procedure, 1 min after needling
Heart Rate (beat/min)	baseline, during needling procedure, 1 min after needling

Trial Locations

Locations (1)

Ankara Etlik City Hospital; 🇹🇷 Ankara, Turkey