Double-dorsal Versus Single-volar Digital Block

February 15, 2024 updated by: Ankara City Hospital Bilkent

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

Detailed Description

Randomized, parallel controlled, open labeled experimental study

Study Type

Interventional

Enrollment (Actual)

160

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

      • Ankara, Turkey
        • Ankara City Hospital Emergency Medicine Department

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

No

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

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: 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

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

Investigators

  • Principal Investigator: Alp Şener, Assoc prof, Ankara Yıldırım Beyazıt University Faculty of Medicine

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)

October 12, 2022

Primary Completion (Actual)

July 12, 2023

Study Completion (Actual)

September 12, 2023

Study Registration Dates

First Submitted

February 8, 2024

First Submitted That Met QC Criteria

February 15, 2024

First Posted (Actual)

February 23, 2024

Study Record Updates

Last Update Posted (Actual)

February 23, 2024

Last Update Submitted That Met QC Criteria

February 15, 2024

Last Verified

February 1, 2024

More Information

Terms related to this study

Additional Relevant MeSH Terms

Other Study ID Numbers

  • E2-22-2566

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

product manufactured in and exported from the U.S.

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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