Distal Radius FractureNCT05832021
Comparison of Clinical Outcomes of Distal Radius Fractures Treated Surgically With WALANT and Peripheral Nerve Block
An observational study of Distal Radius Fracture, run by Diskapi Yildirim Beyazit Education and Research Hospital at 1 site in Turkey (Türkiye).
Trial summary
WALANT anesthesia technique has been frequently preferred in hand and upper extremity surgery in recent years. WALANT technique; It stands out with its advantages such as lack of pre-operative anesthesia preparation process, reduction in test and examination requests, reduction in unnecessary hospitalizations and high… Read more about this study
- Who is it for?
- Ages 18 to 100 years
- Conditions the study is for
- Distal Radius Fracture
- What is being tested?
- Open reduction and internal fixation (under WALANT) and Open reduction and internal fixation (under peripheral nerve block)
- Type of treatment
- Surgery or procedure
- How many people
- 48 participants
- Where
- 1 siteTurkey (Türkiye)
- Study dates
- 19 Apr 2021to 20 May 2022
- Phase
- Observational
- 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 100 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Study population: A total of 50 patients are planned to be included in the study.
Who may be able to join
- Patients older than 18 years of age
- Patients who had acute distal radius fracture which underwent surgery
Who cannot join
- Patients with open fractures
- Additional injuries in the same extremity, peripheral vascular disease, and local anesthetic allergy at the time of first admission
- Patients who are switched to general anesthesia after both techniques
- Patients who underwent a second surgery on the same extremity due to any complication
- Patients who had lacked follow-up examination information
Trial locations and contacts
1 site in 1 country.
Turkey (Türkiye)1 site
Diskapi Yildirim Beyazit Education and Research Hospital
Ankara, 06110
About this study
Official title: Comparison of Patients With Distal Radius Fracture Who Underwent Surgery With WALANT Technique or Peripheral Nerve Block Anesthesia Methods in Terms of Patient Satisfaction and Functional Results in the Postoperative Period
WALANT anesthesia technique has been frequently preferred in hand and upper extremity surgery in recent years. WALANT technique; It stands out with its advantages such as lack of pre-operative anesthesia preparation process, reduction in test and examination requests, reduction in unnecessary hospitalizations and high patient satisfaction. There are studies with a high level of evidence showing that the WALANT technique has such advantages in soft tissue and smallmedium bone fracture surgery. In large bone fractures (radius, etc.), surgical treatment is performed with the WALANT technique and positive results have been reported. Although there is a study comparing WALANT and general anesthesia in the surgical treatment of distal radius fractures, there is no study comparing the peripheral nerve block technique.
- Conditions
- Distal Radius Fracture
- Being tested
- Open reduction and internal fixation (under WALANT), Open reduction and internal fixation (under peripheral nerve block)
- Keywords
- WALANT, Distal Radius Fracture, Peripheral nerve block
- Medical subject headings
- Wrist Fractures
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Open reduction and internal fixation (under WALANT)Procedure or surgery
Open reduction and internal fixation with volar Henry approach under WALANT.
Open reduction and internal fixation (under peripheral nerve block)Procedure or surgery
Open reduction and internal fixation with volar Henry approach under peripheral nerve block.
| Study group | Role | What they receive |
|---|---|---|
| WALANT | Patients with distal radius fracture who underwent surgical treatment under WALANT. Receives: Procedure: Open reduction and internal fixation (under WALANT) | |
| Peripheral nerve block | Patients with distal radius fracture who underwent surgical treatment under peripheral nerve block. Receives: Procedure: Open reduction and internal fixation (under peripheral nerve block) |
What is being measured
The primary outcome is the main question the study is designed to answer.
Changes in the patient's pain
Visual Analogue Scale (VAS) scale (1 to 10 score. 10 means worst pain possible, 1 is almost no pain) to measure pain level
Measured: Baseline, immediately after the surgery, 2 weeks after surgery, 6 weeks after surgery, 12 weeks after surgery, 24 weeks after surgery
Changes in the patient's anxiety
State-Trait Anxiety Inventory (STAI-TX) (no anxiety: 1 point, a little anxiety: 2 points, anxious: 3 points, very anxious: 4 points) to measure anxiety
Measured: Baseline, immediately after the surgery, 2 weeks after surgery, 6 weeks after surgery, 12 weeks after surgery, 24 weeks after surgery
Secondary outcomes (5)
Number of complications after surgery
Description of complications regarding surgery or anesthetical technique
Measured: Collected at end of follow up (24 months)
Evolution in postoperative wrist mobility
Flexion, extension, radial and ulnar deviation, pronation and supination using a goniometer (degree)
Measured: Baseline, 2 weeks after surgery, 6 weeks after surgery, 12 weeks after surgery, 24 weeks after surgery
Number of patients who need conversion to general anaesthesia due to lack of effectiveness of anaesthetic technique
Yes or no answer to the question "did the patient need reconversion to general anaesthesia?"
Measured: During surgery (intraoperative)
Description of reason why the patient needed adding some extra anaesthesia if necessary due to lack of effectiveness of the main anaesthetic technique
Open ended question describing the reason of anaesthesia insufficiency (for instance: pain, anxiety, discomfort, etc)
Measured: During surgery (intraoperative)
Type of anaesthetic technique added to solve the lack of effectiveness of the main anaesthesia
Open ended question describing the technique used in order to resolve lack of anaesthesia if needed (sedation, extra doses of local anaesthetic, anatomic location of local anaesthetic, doses of local anaesthetic, etc)
Measured: During surgery (intraoperative)
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted27 Apr 2023
- Study start19 Apr 2021
- Primary completion20 May 2022
- Study completion20 May 2022
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Distal Radius FractureStudies 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
- Observational
- Observational model
- Cohort
- Time perspective
- Prospective
- Enrolment
- 48 participants (actual)
Sponsor and investigators
- Lead sponsor
- Diskapi Yildirim Beyazit Education and Research Hospital
- Sponsor type
- Other government
- Responsible party
- Principal investigator, Huseyin Bilgehan Cevik, Diskapi Yildirim Beyazit Education and Research Hospital
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT05832021
- Sponsor's protocol ID
- 109/21
- Status last verified
- Apr 2023
- First submitted
- 15 Nov 2022
- Last updated
- 1 May 2023
- Results posted
- 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 1 May 2023. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Comparison of Patients With Distal Radius Fracture Who Underwent Surgery With WALANT Technique or Peripheral Nerve Block Anesthesia Methods in Terms of Patient Satisfaction and Functional Results in the Postoperative Period
- ClinicalTrials.gov ID
- NCT05832021
- Acronym / sponsor ID
- 109/21
- Conditions
- Distal Radius Fracture
- Keywords
- WALANT, Distal Radius Fracture, Peripheral nerve block
- Study type
- Observational
- Recruitment status
- Completed
- Enrolment
- 48 participants (actual)
- Lead sponsor
- Diskapi Yildirim Beyazit Education and Research HospitalOther government
- Study start
- 19 Apr 2021 (actual)
- Primary completion
- 20 May 2022 (actual)
- Study completion
- 20 May 2022 (actual)
- First posted
- 27 Apr 2023 (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.
WALANT anesthesia technique has been frequently preferred in hand and upper extremity surgery in recent years. WALANT technique; It stands out with its advantages such as lack of pre-operative anesthesia preparation process, reduction in test and examination requests, reduction in unnecessary hospitalizations and high patient satisfaction. There are studies with a high level of evidence showing that the WALANT technique has such advantages in soft tissue and smallmedium bone fracture surgery. In large bone fractures (radius, etc.), surgical treatment is performed with the WALANT technique and positive results have been reported. Although there is a study comparing WALANT and general anesthesia in the surgical treatment of distal radius fractures, there is no study comparing the peripheral nerve block technique.
Study design
- Observational model
- Cohort
- Time perspective
- Prospective
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| WALANT | – | Procedure: Open reduction and internal fixation (under WALANT)Patients with distal radius fracture who underwent surgical treatment under WALANT. |
| Peripheral nerve block | – | Procedure: Open reduction and internal fixation (under peripheral nerve block)Patients with distal radius fracture who underwent surgical treatment under peripheral nerve block. |
Who may qualify
- Ages
- 18 to 100 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
- Study population
- A total of 50 patients are planned to be included in the study.
Key inclusion criteria (2 listed)
- Patients older than 18 years of age
- Patients who had acute distal radius fracture which underwent surgery
Key exclusion criteria (5 listed)
- Patients with open fractures
- Additional injuries in the same extremity, peripheral vascular disease, and local anesthetic allergy at the time of first admission
- Patients who are switched to general anesthesia after both techniques
- Patients who underwent a second surgery on the same extremity due to any complication
- Patients who had lacked follow-up examination information
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 |
|---|---|---|
| Open reduction and internal fixation (under WALANT)Open reduction and internal fixation with volar Henry approach under WALANT. | Procedure or surgery | WALANT |
| Open reduction and internal fixation (under peripheral nerve block)Open reduction and internal fixation with volar Henry approach under peripheral nerve block. | Procedure or surgery | Peripheral nerve block |
Primary outcome
Changes in the patient's pain
Time frame: Baseline, immediately after the surgery, 2 weeks after surgery, 6 weeks after surgery, 12 weeks after surgery, 24 weeks after surgery
Visual Analogue Scale (VAS) scale (1 to 10 score. 10 means worst pain possible, 1 is almost no pain) to measure pain level
Changes in the patient's anxiety
Time frame: Baseline, immediately after the surgery, 2 weeks after surgery, 6 weeks after surgery, 12 weeks after surgery, 24 weeks after surgery
State-Trait Anxiety Inventory (STAI-TX) (no anxiety: 1 point, a little anxiety: 2 points, anxious: 3 points, very anxious: 4 points) to measure anxiety
5 secondary outcomes
Number of complications after surgery
Time frame: Collected at end of follow up (24 months)
Evolution in postoperative wrist mobility
Time frame: Baseline, 2 weeks after surgery, 6 weeks after surgery, 12 weeks after surgery, 24 weeks after surgery
Number of patients who need conversion to general anaesthesia due to lack of effectiveness of anaesthetic technique
Time frame: During surgery (intraoperative)
Description of reason why the patient needed adding some extra anaesthesia if necessary due to lack of effectiveness of the main anaesthetic technique
Time frame: During surgery (intraoperative)
Type of anaesthetic technique added to solve the lack of effectiveness of the main anaesthesia
Time frame: During surgery (intraoperative)
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 1 May 2023.
- 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.
The record lists no contact. Use the official record to reach the sponsor.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Distal Radius Fracture, run by Diskapi Yildirim Beyazit Education and Research Hospital 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 2 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 1 May 2023. 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?
Changes in the patient's pain (time frame: Baseline, immediately after the surgery, 2 weeks after surgery, 6 weeks after surgery, 12 weeks after surgery, 24 weeks after surgery). The study lists 2 primary outcomes in all. 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 1 May 2023.