The Effect of Topical Vibration on Injection Pain in Scalp Block

NCT ID: NCT06038825

Last Updated: 2024-05-16

Basic Information

• Recruitment Status: COMPLETED
• Clinical Phase: NA
• Total Enrollment: 56 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2023-06-01
• Study Completion Date: 2024-02-28

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.

Conditions

Analgesia

Study Design

• Allocation Method: NON_RANDOMIZED
• Intervention Model: CROSSOVER
• Primary Study Purpose: SUPPORTIVE_CARE
• Blinding Strategy: NONE

Study Groups

topical vibration

For all patients one half of the scalp was injected with vibration device.

Group Type: ACTIVE_COMPARATOR

topical vibration

Intervention Type: DEVICE

topical vibration (Aprilla brand, giving 6000 vibrations per minute) is a device for pain relief during injection of local anesthetic.

control

Same patient's other side of the scalp was injected without vibration device.

Group Type: NO_INTERVENTION

No interventions assigned to this group

Interventions

topical vibration

topical vibration (Aprilla brand, giving 6000 vibrations per minute) is a device for pain relief during injection of local anesthetic.

Intervention Type: DEVICE

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

• Minimum Eligible Age: 18 Years
• Maximum Eligible Age: 80 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

Diskapi Teaching and Research Hospital

OTHER

Sponsor Role: lead

Responsible Party

derya özkan

professor medical doctor

Responsibility Role: PRINCIPAL_INVESTIGATOR

Principal Investigators

nur yilmaz, specialist

Role: PRINCIPAL_INVESTIGATOR

Ankara Etlik City Hospital

Locations

Ankara Etlik City Hospital

Ankara, , Turkey (Türkiye)

Countries

Turkey (Türkiye)

References

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

Reference Type: BACKGROUND

PMID: 26933468 (View on PubMed)

Other Identifiers

scalp block

Identifier Type: -

Identifier Source: org_study_id