The Effect of Topical Vibration on Injection Pain in Scalp Block

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.

Study Overview

• Status: Not yet recruiting
• Conditions: Analgesia
• Intervention / Treatment: Device: topical vibration

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 Type: Interventional
• Enrollment (Estimated): 40
• Phase: Not Applicable

Contacts and Locations

• Study Contact: Name: Derya Ozkan, professor; Phone Number: 5425843638; Email: derya_z@yahoo.com

Study Locations

• Turkey
  • Ankara, Turkey
    • Ankara Etlik City Hospital
    • Contact: derya ozkan, professor

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: Adult; Older Adult
• Accepts Healthy Volunteers: No

Description

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 Plan

How is the study designed?

Design Details

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

Number of Arms

2

Arms and Interventions

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

What is the study measuring?

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	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

Collaborators and Investigators

• Sponsor: Diskapi Teaching and Research Hospital
• Investigators: Principal Investigator: nur yilmaz, specialist, Ankara Etlik City Hospital

Publications and helpful links

General Publications

• Kuwahara H, Ogawa R. Using a Vibration Device to Ease Pain During Facial Needling and Injection. Eplasty. 2016 Feb 4;16:e9. eCollection 2016.

Study record dates

Study Major Dates

• Study Start (Estimated): October 18, 2023
• Primary Completion (Estimated): October 30, 2023
• Study Completion (Estimated): December 30, 2023

Study Registration Dates

• First Submitted: August 1, 2023
• First Submitted That Met QC Criteria: September 14, 2023
• First Posted (Actual): September 15, 2023

Study Record Updates

• Last Update Posted (Actual): October 3, 2023
• Last Update Submitted That Met QC Criteria: October 2, 2023
• Last Verified: October 1, 2023

More Information

Terms related to this study

• Keywords: vibration; awake craniotomy; scalp clock
• Other Study ID Numbers: scalp block

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: NO

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No
• product manufactured in and exported from the U.S.: No