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Clinical Trial Details — Status: Completed

Administrative data

NCT number NCT06274073
Other study ID # E2-22-2566
Secondary ID
Status Completed
Phase N/A
First received
Last updated
Start date October 12, 2022
Est. completion date September 12, 2023

Study information

Verified date February 2024
Source Ankara City Hospital Bilkent
Contact n/a
Is FDA regulated No
Health authority
Study type Interventional

Clinical Trial Summary

The aim of this study is to compare the traditional dorsal double injection digital block with the palmar single injection technique in the suturing of acute traumatic hand finger lacerations in terms of injection pain score (NRS), anesthesia onset time, and success of anesthesia. It is understood that single injection digital block and double injection digital block techniques do not have significant advantages over each other in terms of pain levels and procedure times. However, the need for rescue anesthesia was evaluated to be lower in the single injection digital block technique. This difference is especially due to measurements in the volar region incisions. According to the results of this study, we think that choosing the single injection digital block technique for volar region incisions is a more rational approach, especially in terms of the data of the need for rescue anesthesia.


Description:

Randomized, parallel controlled, open labeled experimental study


Recruitment information / eligibility

Status Completed
Enrollment 160
Est. completion date September 12, 2023
Est. primary completion date July 12, 2023
Accepts healthy volunteers No
Gender All
Age group 18 Years to 65 Years
Eligibility Inclusion Criteria: - Between 18-65 years of age - Isolated traumatic acute hand finger lacerations requiring suturing - Admissions within 6 hours of injury - Patients who can cooperate with the NRS score - Patients who gave consent Exclusion Criteria: - Vein, nerve and tendon lacerations on the hand that require repair - Amputation or bone fracture - Those who have used analgesics in the last 12 hours - Hemodynamically unstable patients - Known allergy to prilocaine hydrochloride

Study Design


Intervention

Procedure:
Dorsal digital block
Dorsal regional digital block anesthesia (No drug or device is being investigated here; the two digital block procedure mentioned are compared)
Palmar digital block
Palmar regional digital block anesthesia (No drug or device is being investigated here; the two digital block procedures mentioned are compared)

Locations

Country Name City State
Turkey Ankara City Hospital Emergency Medicine Department Ankara

Sponsors (1)

Lead Sponsor Collaborator
Ankara City Hospital Bilkent

Country where clinical trial is conducted

Turkey, 

Outcome

Type Measure Description Time frame Safety issue
Primary Anesthesia pain score Numerical rating scale (NRS): 0 to 10 (min-max); higher scores indicates more pain 3rd minute
Secondary Anesthesia onset time Time achieved to total anesthesia Measurements are provided per 30 seconds (30-60-90-120 seconds and more if necessary)
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