Comparison of Clinical Outcomes of Distal Radius Fractures Treated Surgically With WALANT and Peripheral Nerve Block

Study Overview
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Brief Summary
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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.

Official Title
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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

Conditions
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Distal Radius Fracture

Intervention / Treatment
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* Procedure: Open reduction and internal fixation (under WALANT)
* Procedure: Open reduction and internal fixation (under peripheral nerve block)


Participation Criteria
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Eligibility Criteria
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Inclusion Criteria: Patients older than 18 years of age Patients who had acute distal radius fracture which underwent surgery Exclusion Criteria: 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

Ages Eligible for Study
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Minimum Age: 18 Years
Maximum Age: 100 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| WALANT<br>Patients with distal radius fracture who underwent surgical treatment under WALANT. | Procedure: Open reduction and internal fixation (under WALANT)<br>* Open reduction and internal fixation with volar Henry approach under WALANT.<br>|
| Peripheral nerve block<br>Patients with distal radius fracture who underwent surgical treatment under peripheral nerve block. | Procedure: Open reduction and internal fixation (under peripheral nerve block)<br>* Open reduction and internal fixation with volar Henry approach under peripheral nerve block.<br>|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| 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 | 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 | Baseline, immediately after the surgery, 2 weeks after surgery, 6 weeks after surgery, 12 weeks after surgery, 24 weeks after surgery | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Number of complications after surgery | Description of complications regarding surgery or anesthetical technique | 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) | 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? | 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) | 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) | During surgery (intraoperative) | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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WALANT, Distal Radius Fracture, Peripheral nerve block