Pain and Anxiety During Local Block

Not Applicable

Completed

• Conditions: Anxiety; Anesthesia, Local; Pain
• Interventions: Procedure: Digital block

• Registration Number: NCT06352255
• Lead Sponsor: University of Seville

Brief 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

Detailed Description

Not available

Study Timeline

• Study First Submitted: 2023-10-26
• Study Start: 2024-03-01
• Study First Submitted QC: 2024-04-03
• Study First Posted: 2024-04-08
• Primary Completion: 2024-05-01
• Status Verified: 2024-07
• Study Completion: 2024-07-20
• Last Update Submitted: 2024-07-22
• Last Update Posted: 2024-07-23

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 264

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

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: CROSSOVER

Arm && Interventions

Group	Intervention	Description
Digital block with carpule.	Digital block	The study group will be made up of subjects who will undergo anesthetic block with carpule.
Digital block with syringe.	Digital block	The control group will be made up of the subjects who will undergo anesthetic block with syringe.

Primary Outcome Measures

Name	Time	Method
Grade of Pain postinyection	Immediately after the intervention	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).

Secondary Outcome Measures

Name	Time	Method
Anxiety before the intervention	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.	Compare the degree of anxiety of patients undergoing the anesthetic procedure using syringe vs carpule.

Trial Locations

Locations (1)

Clinica Rayo; 🇪🇸 Sevilla, Spain