Pain and Anxiety During Local Block

Pain Clinical Trial

Official title:

Analysis of Pain and Anxiety With Carpule vs Syringe in Digital Anesthesia of the Hallux

Clinical Trial Details — Status: Not yet recruiting

Administrative data

• NCT number: NCT06352255
• Other study ID #: AR1937
• Status: Not yet recruiting
• Phase: N/A
• Start date: July 2024
• Est. completion date: July 2025

Study information

• Verified date: November 2023
• Source: University of Seville
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial Summary

INTRODUCTION: Currently, there is no scientific evidence about pain in the anesthetic blockage of the first finger according to the application method. However, clinical evidence has valued the use of carpule, due to the low pain it generates in the patient to the application of anesthetic. Most studies on anesthesia and pain, especially with the use of carpule and distracting methods, belong to the field of dentistry.

OBJECTIVES: It is intended to determine the pain after an anesthetic block in H of Frost in the first finger with different application methods, such as syringe and carpule. As secondary objectives, it is intended to establish the difference in pain according to the sex and age of the patients.

METHODOLOGY: Experimental, transverse and random clinical trial type analytical study, in which a sample of 200 individuals will be selected, 100 per group, which would require digital anesthesia of the first finger and that would fulfill the inclusion criteria.

Result: after the completion of the study CONCLUSIONS: After the completion of the study

Recruitment information / eligibility

• Status: Not yet recruiting
• Enrollment: 200
• Est. completion date: July 2025
• Est. primary completion date: December 2024
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: All
• Age group: 18 Years to 80 Years

Eligibility

Inclusion Criteria:

• Subjects over 18 years of age

• Both sexes

• Participants must present nail pathology that requires surgical intervention.

Exclusion Criteria:

• Systemic degenerative

• Neuromuscular diseases

• Pregnant or likely to be pregnant

Related Conditions & MeSH terms

• Anesthesia, Local
• Anxiety
• Anxiety Disorders
• Pain

Intervention

Procedure:
• Digital block
Frost's H technique

Locations

Country	Name	City	State
n/a

Sponsors (1)

Lead Sponsor	Collaborator
University of Seville

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Grade of Pain postinyection	Analyze the pain using the VAS scale (Visual Analog Scale) caused during the anesthetic process. The lowest score on this scale is 0 (no pain) and the highest is 10 (maximum bearable pain).	Immediately after the intervention
Secondary	Anxiety before the intervention	Compare the degree of anxiety of patients undergoing the anesthetic procedure using syringe vs carpule.	Immediately before the intervention, since it is a scale that scores from 1 to 3 the degree of anxiety of the patient prior to the surgical intervention.