WALANT in Distal Radius Fracture Osteosynthesis

Hospital Arnau de Vilanova27 enrolled

Overview

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.

Study Type

INTERVENTIONAL

Allocation

RANDOMIZED

Purpose

SUPPORTIVE_CARE

Masking

DOUBLE

Enrollment

Conditions

Radius Fracture Distal

Interventions

Eligibility

Sex: ALLMin age: 18 YearsHealthy volunteers:

Medical Language ↔ Plain English

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: 1. Unsigned informed consent 2. 17 years old or younger 3. Associated fractures in which additional osteosynthesis was required: scaphoid fracture, ulnar fracture (ulnar styloid osteosynthesis included), bifocal radius fractures, etc 4. Open fractures 5. Polytrauma patients 6. Requiring more than a standard volar DRF approach and/or other than a volar plate. 7. 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: 1. Existence of previous trauma or anatomical distortion of the area that prevents the abduction of the arm 2. Active presence of infection at the locoregional anesthesia puncture site 3. Previous axillary lymphadenopathy 4. Previous history of local anesthetic allergy 5. Severe coagulopathy 6. Severe pre-existing neurological diseases in the upper extremity Contraindications for WALANT anesthetic technique 7. Documented hypersensitivity to lidocaine 8. Compromised peripheral circulation 9. Patients with previous vascular pathology, a history of vasculitis, Buerger's disease, and scleroderma 10. Patients with infection of the area surrounding the injection

Outcomes

Primary Outcomes

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)

Time frame: 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.

Time frame: 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)

Time frame: Written down in a questionnaire form delivered and answered by the patient between 10 and 15 days after surgery.

Secondary Outcomes

Evolution of active bleeding through surgical wound after surgery

Presence of active bleeding through the surgical wound

Time frame: 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)

Time frame: 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)

Time frame: 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.

Time frame: During surgery

Number of complications after surgery

Description of complications regarding surgery or anesthetical technique

Time frame: 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)

Time frame: 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)

Time frame: 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)

Time frame: 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?"

Time frame: 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?"

Time frame: 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)

Time frame: 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)

Time frame: During surgery

WALANT in Distal Radius Fracture Osteosynthesis

Overview

Conditions

Interventions

Eligibility

Locations (1)

Outcomes

Primary Outcomes

Secondary Outcomes