Skip to main content
OpenTrials
Completed

NCT Number: NCT06352255

Pain and Anxiety During Local Block

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

Completed

Looking for future studies?

Notify Me

Key information

Conditions

Anesthesia, Local Anxiety Anxiety Disorders Mental Disorders Neurologic Manifestations Pain Pathological Conditions, Signs and Symptoms Signs and Symptoms

Age range

18 year–80 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

Clinica Rayo

Seville, 41008, Spain

Who can participate

Healthy volunteers accepted: Yes

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

Digital block

Procedure

Frost's H technique

Primary outcomes

  1. Grade of Pain postinyection

    Time frame: 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 outcomes

  1. Anxiety before the intervention

    Time frame: 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.

Sponsors and collaborators

Lead sponsor

University of Seville

Other

Registry information

Official study title

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

Important dates

Study start
2024
Primary completion
2024
Study completion
2024
First posted
Apr 8, 2024
Registry last updated
Jul 23, 2024

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

Related clinical trials

Published trials that share one or more normalized conditions with this study.