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Pain and Anxiety During Local Block

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

Status
Completed
Phases
NA
Study type
Interventional
Source
ClinicalTrials.gov
Registry ID
NCT06352255
Enrollment
264
Registered
2024-04-08
Start date
2024-03-01
Completion date
2024-07-20
Last updated
2024-07-23

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Anesthesia, Local, Anxiety, Pain

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

Interventions

PROCEDUREDigital block

Frost's H technique

Sponsors

University of Seville
Lead SponsorOTHER

Study design

Allocation
RANDOMIZED
Intervention model
CROSSOVER
Primary purpose
OTHER
Masking
DOUBLE (Subject, Investigator)

Eligibility

Sex/Gender
ALL
Age
18 Years to 80 Years
Healthy volunteers
Yes

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

Design outcomes

Primary

MeasureTime frameDescription
Grade of Pain postinyectionImmediately after the interventionAnalyze 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

MeasureTime frameDescription
Anxiety before the interventionImmediately 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.

Countries

Spain

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Feb 4, 2026