Laceration of SkinNCT06274073
Double-dorsal Versus Single-volar Digital Block
A study testing Dorsal digital block and Palmar digital block in people with Laceration of Skin and Anesthesia, Local, run by Ankara City Hospital Bilkent at 1 site in Turkey (Türkiye).
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. Read more about this study
- Who is it for?
- Ages 18 to 65 years
- Conditions the study is for
- Laceration of Skin, Anesthesia, Local, Pain
- What is being tested?
- Dorsal digital block and Palmar digital block
- Type of treatment
- Injection or infusion, Surgery or procedure
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 160 participants
- Where
- 1 siteTurkey (Türkiye)
- Study dates
- 12 Oct 2022to 12 Sep 2023
- Phase
- Interventional
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 to 65 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- 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
Who cannot join
- 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
Trial locations and contacts
1 site in 1 country.
Turkey (Türkiye)1 site
Ankara City Hospital Emergency Medicine Department
Ankara
About this study
Official title: 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.
Read more
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.
Read the detailed description
Randomized, parallel controlled, open labeled experimental study
- Conditions
- Laceration of Skin, Anesthesia, Local, Pain, Nerve Block
- Being tested
- Dorsal digital block, Palmar digital block
- Keywords
- Digital nerve block, Finger lacerations, Single palmar injection, Double dorsal injection, Pain
- Medical subject headings
- Pain
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Dorsal digital blockProcedure or surgery
Dorsal regional digital block anesthesia (No drug or device is being investigated here; the two digital block procedure mentioned are compared)
Palmar digital blockProcedure or surgery
Palmar regional digital block anesthesia (No drug or device is being investigated here; the two digital block procedures mentioned are compared)
| Study group | Role | What they receive |
|---|---|---|
| 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. Receives: 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. Receives: Procedure: Dorsal digital block |
What is being measured
The primary outcome is the main question the study is designed to answer.
Anesthesia pain score
Numerical rating scale (NRS): 0 to 10 (min-max); higher scores indicates more pain
Measured: 3rd minute
Secondary outcomes (1)
Anesthesia onset time
Time achieved to total anesthesia
Measured: Measurements are provided per 30 seconds (30-60-90-120 seconds and more if necessary)
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted23 Feb 2024
- Study start12 Oct 2022
- Primary completion12 Jul 2023
- Study completion12 Sep 2023
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Laceration of SkinStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Model description
- Two parallel groups (two digital block techniques)
- Masking
- Single blind
- Who is masked
- Outcomes assessor
- Enrolment
- 160 participants (actual)
Sponsor and investigators
- Lead sponsor
- Ankara City Hospital Bilkent
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
- Investigators
- Alp Şener, Assoc prof, Principal investigator, Ankara Yıldırım Beyazıt University Faculty of Medicine
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06274073
- Sponsor's protocol ID
- E2-22-2566
- Status last verified
- Feb 2024
- First submitted
- 8 Feb 2024
- Last updated
- 23 Feb 2024
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 23 Feb 2024. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Double-dorsal Versus Single-volar Digital Subcutaneous Anaesthetic Injection for Finger Injuries in the Emergency Department: A Randomised Controlled Trial
- ClinicalTrials.gov ID
- NCT06274073
- Acronym / sponsor ID
- E2-22-2566
- Conditions
- Laceration of Skin, Anesthesia, Local, Pain, Nerve Block
- Keywords
- Digital nerve block, Finger lacerations, Single palmar injection, Double dorsal injection, Pain
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 160 participants (actual)
- Lead sponsor
- Ankara City Hospital BilkentUniversity, hospital or other
- Study start
- 12 Oct 2022 (actual)
- Primary completion
- 12 Jul 2023 (actual)
- Study completion
- 12 Sep 2023 (actual)
- First posted
- 23 Feb 2024 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Detailed description
Randomized, parallel controlled, open labeled experimental study
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind (outcomes assessor)
- Number of arms
- 2
- Model description
- Two parallel groups (two digital block techniques)
| Arm | Type | Receives |
|---|---|---|
| Single injection palmar digital block | Experimental | Procedure: Palmar digital blockThe 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. |
| Double injection dorsal digital block | Experimental | Procedure: Dorsal digital blockThe 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. |
Who may qualify
- Ages
- 18 to 65 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (5 listed)
- 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
Key exclusion criteria (5 listed)
- 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
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Dorsal digital blockDorsal regional digital block anesthesia (No drug or device is being investigated here; the two digital block procedure mentioned are compared) | Procedure or surgery | Double injection dorsal digital block |
| Palmar digital blockPalmar regional digital block anesthesia (No drug or device is being investigated here; the two digital block procedures mentioned are compared) | Procedure or surgery | Single injection palmar digital block |
Primary outcome
Anesthesia pain score
Time frame: 3rd minute
Numerical rating scale (NRS): 0 to 10 (min-max); higher scores indicates more pain
1 secondary outcome
Anesthesia onset time
Time frame: Measurements are provided per 30 seconds (30-60-90-120 seconds and more if necessary)
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 23 Feb 2024.
- Individual participant dataSharing planned: No
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Alp Şener, Assoc prof principal investigator
Ankara Yıldırım Beyazıt University Faculty of Medicine
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Dorsal digital block and Palmar digital block in people with Laceration of Skin and Anesthesia, Local, run by Ankara City Hospital Bilkent at 1 site in Turkey (Türkiye).
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 5 inclusion and 5 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 23 Feb 2024. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Turkey (Türkiye). Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Anesthesia pain score (time frame: 3rd minute). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 23 Feb 2024.