WALANT in Distal Radius Fracture Osteosynthesis

Study Overview
=================
Brief Summary
-----------------
The purpose of this study is to assess the applicability and potential benefits of Wide Awake Local Anesthesia No Tourniquet (WALANT) or Local Anesthesia No Tourniquet (LANT) versus locoregional anesthesia (LRA) and tourniquet in osteosynthesis of distal radius fractures (DRF) during the immediate postoperative period. Our hypothesis is that being able to avoid the use of a limb tourniquet in such a procedure may cause less swelling and better surgical wound appearance in the immediate postoperative period, without compromising pain level, patient satisfaction, or improving the number of complications. In this regard, prospective randomized study was designed comparing short term results of patients who were operated using WALANT (A) to locoregional anesthesia (LRA) and tourniquet (B). Main outcomes were pain, swelling and patient satisfaction. Surgical wound bleeding,mobility, surgeon's technical difficulty, insufficient anesthesia and complications were also evaluated.

Official Title
-----------------
Assessing the Applicability and Potential Benefits of Wide Awake Local Anaesthesia No Tourniquet in Distal Radius Fracture Osteosynthesis.

Conditions
-----------------
Radius Fracture Distal

Intervention / Treatment
-----------------
* Procedure: WALANT
* Procedure: Locoregional anesthesia and tourniquet


Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: Patients who attended our hospital from December 2020th to December 2021 with DRF requiring surgical treatment who provided written informed consent and did not have any of the following excluding conditions described below Exclusion Criteria: Unsigned informed consent 17 years old or younger Associated fractures in which additional osteosynthesis was required: scaphoid fracture, ulnar fracture (ulnar styloid osteosynthesis included), bifocal radius fractures, etc Open fractures Polytrauma patients Requiring more than a standard volar DRF approach and/or other than a volar plate. DRF with >30 days or DRF malunions Contraindications to the use of ischemia a. Peripheral vascular disease b. Extensive soft tissue injury c. Peripheral neuropathy d. Severe infection e. Thromboembolic disease in the extremity f. Poor skin conditions g. Arteriovenous fistula h. Sickle cell hemoglobinopathy Contraindications for proximal blocking: Existence of previous trauma or anatomical distortion of the area that prevents the abduction of the arm Active presence of infection at the locoregional anesthesia puncture site Previous axillary lymphadenopathy Previous history of local anesthetic allergy Severe coagulopathy Severe pre-existing neurological diseases in the upper extremity Contraindications for WALANT anesthetic technique Documented hypersensitivity to lidocaine Compromised peripheral circulation Patients with previous vascular pathology, a history of vasculitis, Buerger's disease, and scleroderma Patients with infection of the area surrounding the injection

Ages Eligible for Study
-----------------
Minimum Age: 18 Years

Sexes Eligible for Study
-----------------
All

Accepts Healthy Volunteers
-----------------
Accepts Healthy Volunteers

Study Plan
=================
How is the study designed?
-----------------

Design Details

Primary Purpose: Supportive Care
Allocation: Randomized
Intervention Model: Parallel Assignment
Interventional Model Description: Patients who had a surgical distal radius fracture, met all the inclusion criteria and signed the informed consent were randomized either to Group A in which WALANT technique was performed or Group B in which locoregional anesthesia(LRA) and upper limb tourniquet was used. This process was done by the external observer with 10 block randomization. Blinding was not possible as the differences between the anesthetic techniques are evident. However, none of the patients nor the surgeon or the anesthesiologist knew the group of intervention until the patient arrived at the operating anteroom the same day of surgery. Since the investigators considered this was a complex intervention, all patients were offered to receive sedation from the anesthesiologist if they presented any level of anxiety.
Masking: Double


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: WALANT<br>Wide awake local anesthesia without tourniquet was used for surgery | Procedure: WALANT<br>* Wide awake local anesthesia without tourniquet for distal radius fracture surgery<br>|
| Active Comparator: Locoregional anesthesia and tourniquet<br>Locoregional anesthesia (normally axillary block) and tourniquet was used for surgery | Procedure: Locoregional anesthesia and tourniquet<br>* Locoregional anesthesia and tourniquet for distal radius fracture surgery<br>|

What is the study measuring?
-----------------
Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Change between baseline patient's pain, immediately after the intervention, 24 hours after surgery, between 10 or 15 days after surgery and at 1 month after surgery | Pain using Visual Analogue Scale (VAS) scale and analgesia used (1 to 10 score. 10 means worst pain possible, 1 is almost no pain) | Baseline, 24 hours after surgery, between 10 and 15 days after surgery, 1 month follow up | 
| Change in baseline wrist swelling with 24 hours after surgery, between 10 or 15 days after surgery and at 1 month after surgery. | Difference between preoperative and postoperative swelling. Swelling was measured as Proximal wrist crease perimeter (cm). Healthy wrist was also measured to allow comparison. | Baseline, 24 hours after surgery, between 10 and 15 days after surgery, 1 month follow up | 
| Patient satisfaction | Index of satisfaction, willingness to repeat and recommend the anesthetic technique. Personal designed Satisfaction scale (1 no satisfied- 5 very satisfied); 2 questions about whether he/she would repeat and recommend the anesthesia received (Yes/No answer) | Written down in a questionnaire form delivered and answered by the patient between 10 and 15 days after surgery. | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Evolution of active bleeding through surgical wound after surgery | Presence of active bleeding through the surgical wound | 24 hours after surgery, between 10 and 15 days after surgery, 1 month follow up | 
| Evolution in postoperative thumb mobility | Kapandji scale for thumb mobility (1 to 10 scale. 10 represents the best thumb mobility and opposition possible, while 1 is almost no mobility) | 24 hours after surgery, between 10 and 15 days after surgery, 1 month follow up | 
| Difficulty in visualization of surgical field | Asked by the external observer to the surgeon right after the surgery had finished. Personal scale (1 easy- 5 very difficult) | During surgery | 
| Stress during surgery | asked by the external observer to the surgeon right after the surgery had finished. Yes/no question and description of the reason of stress if any. | During surgery | 
| Number of complications after surgery | Description of complications regarding surgery or anesthetical technique | Collected at end of follow up (1 month) | 
| Evolution in postoperative finger mobility | Capability to reach the distal and the proximal palmar crease with the tip of the fingers, named after 1st line and 2nd line respectively (according to intrinsic and extrinsic movement). If not arrived, the investigator's used the number of the observer's finger widths left to arrive each crease (i.e. 1 finger widths, 2 fingers widths) | 24 hours after surgery, between 10 and 15 days after surgery, 1 month follow up | 
| Evolution of surgical wound bleeding after surgery | Amount of blood encountered in the dressings (measured as on third, two thirds or more than two thirds of blood within the whole dressing/gauge) | 24 hours after surgery, between 10 and 15 days after surgery, 1 month follow up | 
| Evolution in postoperative wrist mobility | Flexion, extension, radial and ulnar deviation, pronation and supination using a goniometer (º) | 24 hours after surgery, between 10 and 15 days after surgery, 1 month follow up | 
| Number of patients who need reconversion to general anaesthesia due to lack of effectiveness of anaesthetic technique | Yes or no answer to the question does the patient need reconversion to general anaesthesia? | During surgery | 
| Number of patients who need adding some extra anaesthesia due to lack of effectiveness of anaesthetic technique | Yes or no answer to the question does the patient need extra anaesthesia? | During surgery | 
| Description of reason why the patient needs adding some extra anaesthesia if necessary due to lack of effectiveness of the main anaesthetic technique | Open answer question describing the reason of anaesthesia insufficiency (for instance: pain, anxiety, discomfort, etc) | During surgery | 
| Type of anaesthetic technique added to solve the lack of effectiveness of the main anaesthesia | Open answer 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 | 

 Terms related to the study
=================
Keywords Provided by Centre Hospitalier Valida
-----------------
Radius Fracture Distal, Local Anesthesia, Brachial Plexus Anesthesia, Osteosynthesis, Fracture