Pain and Anxiety During Local Block

July 22, 2024 updated by: ANA MARIA RAYO PEREZ, University of Seville

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

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

Study Overview

Status

Completed

Conditions

Intervention / Treatment

Study Type

Interventional

Enrollment (Actual)

264

Phase

  • Not Applicable

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • Spain
      • Sevilla, Spain, 41008
        • Clinica Rayo

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

  • Adult
  • Older Adult

Accepts Healthy Volunteers

Yes

Description

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 Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Other
  • Allocation: Randomized
  • Interventional Model: Crossover Assignment
  • Masking: Double

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
Experimental: Digital block with carpule.
The study group will be made up of subjects who will undergo anesthetic block with carpule.
Procedure: Digital block
Frost's H technique
Active Comparator: Digital block with syringe.
The control group will be made up of the subjects who will undergo anesthetic block with syringe.
Procedure: Digital block
Frost's H technique

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
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).
Immediately after the intervention

Secondary Outcome Measures

Outcome Measure
Measure Description
Time Frame
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.
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.

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

University of Seville

Investigators

  • Principal Investigator: ANA M RAYO PEREZ, Doctor, University of Seville

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

March 1, 2024

Primary Completion (Actual)

May 1, 2024

Study Completion (Actual)

July 20, 2024

Study Registration Dates

First Submitted

October 26, 2023

First Submitted That Met QC Criteria

April 3, 2024

First Posted (Actual)

April 8, 2024

Study Record Updates

Last Update Posted (Actual)

July 23, 2024

Last Update Submitted That Met QC Criteria

July 22, 2024

Last Verified

July 1, 2024

More Information

Terms related to this study

Additional Relevant MeSH Terms

Other Study ID Numbers

  • AR1937

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

NO

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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