- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT06274073
Double-dorsal Versus Single-volar Digital Block
Double-dorsal Versus Single-volar Digital Subcutaneous Anaesthetic Injection for Finger Injuries in the Emergency Department: A Randomised Controlled Trial
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.
Study Overview
Status
Conditions
Intervention / Treatment
Detailed Description
Study Type
Enrollment (Actual)
Phase
- Not Applicable
Contacts and Locations
Study Locations
-
-
-
Ankara, Turkey
- Ankara City Hospital Emergency Medicine Department
-
-
Participation Criteria
Eligibility Criteria
Ages Eligible for Study
- Adult
- Older Adult
Accepts Healthy Volunteers
Description
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 Plan
How is the study designed?
Design Details
- Primary Purpose: Treatment
- Allocation: Randomized
- Interventional Model: Parallel Assignment
- Masking: Single
Arms and Interventions
Participant Group / Arm |
Intervention / Treatment |
|---|---|
|
Experimental: Single injection palmar digital block
The needle was inserted into the subcutaneous region from the palmar side to the root of the proximal phalanx, perpendicular to the frontal plane and the finger.
For anesthesia, 3 ml of anesthetic agent (prilocaine hydrochloride) was applied to the described point with this single injection and the needle was slowly removed.
|
Palmar regional digital block anesthesia (No drug or device is being investigated here; the two digital block procedures mentioned are compared)
|
|
Experimental: Double injection dorsal digital block
The needle was inserted into the proximal dorsal root of the proximal phalanx, into both the medial and lateral parts, perpendicular to the fingers and the frontal plane.
After the aspiration, the injection was performed slowly and the needle was withdrawn concurently.
A total of 3 ml of anesthetic agent (prilocaine hydrochloride) was injected into both the medial and lateral parts of the finger, 1.5 ml for each side.
|
Dorsal regional digital block anesthesia (No drug or device is being investigated here; the two digital block procedure mentioned are compared)
|
What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
|---|---|---|
|
Anesthesia pain score
Time Frame: 3rd minute
|
Numerical rating scale (NRS): 0 to 10 (min-max); higher scores indicates more pain
|
3rd minute
|
Secondary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
|---|---|---|
|
Anesthesia onset time
Time Frame: Measurements are provided per 30 seconds (30-60-90-120 seconds and more if necessary)
|
Time achieved to total anesthesia
|
Measurements are provided per 30 seconds (30-60-90-120 seconds and more if necessary)
|
Collaborators and Investigators
Sponsor
Investigators
- Principal Investigator: Alp Şener, Assoc prof, Ankara Yıldırım Beyazıt University Faculty of Medicine
Study record dates
Study Major Dates
Study Start (Actual)
Primary Completion (Actual)
Study Completion (Actual)
Study Registration Dates
First Submitted
First Submitted That Met QC Criteria
First Posted (Actual)
Study Record Updates
Last Update Posted (Actual)
Last Update Submitted That Met QC Criteria
Last Verified
More Information
Terms related to this study
Keywords
Additional Relevant MeSH Terms
Other Study ID Numbers
- E2-22-2566
Plan for Individual participant data (IPD)
Plan to Share Individual Participant Data (IPD)?
Drug and device information, study documents
Studies a U.S. FDA-regulated drug product
Studies a U.S. FDA-regulated device product
product manufactured in and exported from the U.S.
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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