Skip to main content
Clinical Trials/NCT06038825
NCT06038825
Completed
N/A

The Effect of Topical Vibration on Injection Pain in Scalp Block

Diskapi Teaching and Research Hospital1 site in 1 country56 target enrollmentJune 1, 2023
ConditionsAnalgesia

Overview

Phase
N/A
Intervention
Not specified
Conditions
Analgesia
Sponsor
Diskapi Teaching and Research Hospital
Enrollment
56
Locations
1
Primary Endpoint
pain score (NRS)
Status
Completed
Last Updated
last year

Overview

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.

Registry
clinicaltrials.gov
Start Date
June 1, 2023
End Date
February 28, 2024
Last Updated
last year
Study Type
Interventional
Study Design
Crossover
Sex
All

Investigators

Responsible Party
Principal Investigator
Principal Investigator

derya özkan

professor medical doctor

Diskapi Teaching and Research Hospital

Eligibility Criteria

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

Outcomes

Primary Outcomes

pain score (NRS)

Time Frame: during needling (injection) procedure

0 ; no pain,10; the worst pain ever possible

Secondary Outcomes

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

Study Sites (1)

Loading locations...

Similar Trials