Double-dorsal Versus Single-volar Digital Block

NCT06274073 | Completed

• 1 other identifier: E2-22-2566
• Study Type: interventional
• Target: 160
• Locations: 1 country
• Sites: 1

Brief 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.

Conditions

Laceration of Skin; Anesthesia, Local; Pain; Nerve Block

Keywords

Digital nerve block; Finger lacerations; Single palmar injection; Double dorsal injection; Pain

Outcome Measures

Primary Outcomes (1)

• Anesthesia pain score

  Numerical rating scale (NRS): 0 to 10 (min-max); higher scores indicates more pain

  3rd minute

Secondary Outcomes (1)

• Anesthesia onset time

  Measurements are provided per 30 seconds (30-60-90-120 seconds and more if necessary)

Study Arms (2)

Single injection palmar digital block

EXPERIMENTAL

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.

Procedure: Palmar digital block

Double injection dorsal digital block

EXPERIMENTAL

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 After the aspiration, the injection was performed slowly and the needle was withdrawn concurently.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.

Procedure: Dorsal digital block

Interventions

Dorsal digital block PROCEDURE

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

Double injection dorsal digital block

Palmar digital block PROCEDURE

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

Single injection palmar digital block

Eligibility Criteria

• Age: 18 Years - 65 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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

You may not qualify if:

• 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

Sponsors & Collaborators

• Ankara City Hospital Bilkent: lead

Study Sites (1)

Ankara City Hospital Emergency Medicine Department

Ankara, Turkey (Türkiye)

Location

MeSH Terms

Conditions

Pain

Condition Hierarchy (Ancestors)

Neurologic Manifestations; Signs and Symptoms; Pathological Conditions, Signs and Symptoms

Study Officials

• Alp Şener, Assoc prof

  Ankara Yıldırım Beyazıt University Faculty of Medicine

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: SINGLE
• Who Masked: OUTCOMES ASSESSOR
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Model Details: Two parallel groups (two digital block techniques)

Study Record Dates

• First Submitted: February 8, 2024
• First Posted: February 23, 2024
• Study Start: October 12, 2022
• Primary Completion: July 12, 2023
• Study Completion: September 12, 2023
• Last Updated: February 23, 2024

Record last verified: 2024-02

Data Sharing

• IPD Sharing: Will not share

Locations

TU (1)