Pain and Anxiety During Local Block

NCT06352255 | Completed

• 1 other identifier: AR1937
• Study Type: interventional
• Target: 264
• Locations: 1 country
• Sites: 1

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

Conditions

Anesthesia, Local; Pain; Anxiety

Outcome Measures

Primary Outcomes (1)

• 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 Outcomes (1)

• 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.

Study Arms (2)

Digital block with carpule.

EXPERIMENTAL

The study group will be made up of subjects who will undergo anesthetic block with carpule.

Procedure: Digital block

Digital block with syringe.

ACTIVE COMPARATOR

The control group will be made up of the subjects who will undergo anesthetic block with syringe.

Procedure: Digital block

Interventions

Digital block PROCEDURE

Frost's H technique

Digital block with carpule.; Digital block with syringe.

Eligibility Criteria

• Age: 18 Years - 80 Years
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• Subjects over 18 years of age
• Both sexes
• Participants must present nail pathology that requires surgical intervention.

You may not qualify if:

• Systemic degenerative
• Neuromuscular diseases
• Pregnant or likely to be pregnant

Sponsors & Collaborators

• University of Seville: lead

Study Sites (1)

Clinica Rayo

Seville, 41008, Spain

Location

MeSH Terms

Conditions

Pain; Anxiety Disorders

Condition Hierarchy (Ancestors)

Neurologic Manifestations; Signs and Symptoms; Pathological Conditions, Signs and Symptoms; Mental Disorders

Study Officials

• ANA M RAYO PEREZ, Doctor

  University of Seville

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: DOUBLE
• Who Masked: PARTICIPANT, INVESTIGATOR
• Purpose: OTHER
• Intervention Model: CROSSOVER
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Principal Investigator

Study Record Dates

• First Submitted: October 26, 2023
• First Posted: April 8, 2024
• Study Start: March 1, 2024
• Primary Completion: May 1, 2024
• Study Completion: July 20, 2024
• Last Updated: July 23, 2024

Record last verified: 2024-07

Data Sharing

• IPD Sharing: Will not share

Locations

ES (1)