Clinical trial NCT06038825: The Effect of Topical Vibration on Injection Pain in Scalp Block
Official title: The Effect of Topical Vibration on Injection Pain in Scalp Block
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Analgesia
Keywords: scalp clock
awake craniotomy
vibration
Lead sponsor: Diskapi Teaching and Research Hospital
Sponsor class: OTHER
First posted: 2023-09-15
Enrollment: 56
Sex: ALL
Minimum age (years): 18
Maximum age (years): 80
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: NON_RANDOMIZED
Intervention model: CROSSOVER
Primary purpose: SUPPORTIVE_CARE

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.

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

Primary outcomes:
measure: pain score (NRS)
timeFrame: during needling (injection) procedure
Secondary outcomes:
measure: Mean arterial pressure (mmHg)
timeFrame: baseline, during needling procedure, 1 min after needling
measure: Heart Rate (beat/min)
timeFrame: baseline, during needling procedure, 1 min after needling
Other outcomes:
Locations:
city: Ankara
country: Turkey
facility: Ankara Etlik City Hospital
Study officials:
affiliation: Ankara Etlik City Hospital
name: nur yilmaz, specialist
role: PRINCIPAL_INVESTIGATOR
References:
citation: Kuwahara H, Ogawa R. Using a Vibration Device to Ease Pain During Facial Needling and Injection. Eplasty. 2016 Feb 4;16:e9. eCollection 2016.