The Effect of Topical Vibration on Injection Pain in Scalp Block

Analgesia Clinical Trial

Official title:

The Effect of Topical Vibration on Injection Pain in Scalp Block

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT06038825
• Other study ID #: scalp block
• Status: Completed
• Phase: N/A
• Start date: June 1, 2023
• Est. completion date: February 28, 2024

Study information

• Verified date: May 2024
• Source: Diskapi Teaching and Research Hospital
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 56
• Est. completion date: February 28, 2024
• Est. primary completion date: January 30, 2024
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years to 80 Years

Eligibility

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

Related Conditions & MeSH terms

• Analgesia

Intervention

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

Locations

Country	Name	City	State
Turkey	Ankara Etlik City Hospital	Ankara

Sponsors (1)

Lead Sponsor	Collaborator
Diskapi Teaching and Research Hospital

Country where clinical trial is conducted

Turkey, 

References & Publications (1)

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

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	pain score (NRS)	0 ; no pain,10; the worst pain ever possible	during needling (injection) procedure
Secondary	Mean arterial pressure (mmHg)		baseline, during needling procedure, 1 min after needling
Secondary	Heart Rate (beat/min)		baseline, during needling procedure, 1 min after needling