WALANT in Distal Radius Fracture Osteosynthesis

Radius Fracture Distal Clinical Trial

Official title:

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT05421000
• Other study ID #: CEIC-2360
• Status: Completed
• Phase: N/A
• Start date: December 20, 2020
• Est. completion date: December 31, 2021

Study information

• Verified date: June 2022
• Source: Hospital Arnau de Vilanova
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 27
• Est. completion date: December 31, 2021
• Est. primary completion date: December 22, 2021
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: All
• Age group: 18 Years and older

Eligibility

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

Related Conditions & MeSH terms

• Fractures, Bone
• Radius Fracture Distal
• Radius Fractures

Intervention

Procedure:
• WALANT
Wide awake local anesthesia without tourniquet for distal radius fracture surgery
• Locoregional anesthesia and tourniquet
Locoregional anesthesia and tourniquet for distal radius fracture surgery

Locations

Country	Name	City	State
Spain	Hospital Arnau Vilanova	Lleida	Segria

Sponsors (2)

Lead Sponsor	Collaborator
Hospital Arnau de Vilanova	Institut de Recerca Biomèdica de Lleida

Country where clinical trial is conducted

Spain, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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
Primary	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
Primary	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	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
Secondary	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
Secondary	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
Secondary	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
Secondary	Number of complications after surgery	Description of complications regarding surgery or anesthetical technique	Collected at end of follow up (1 month)
Secondary	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
Secondary	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
Secondary	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
Secondary	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
Secondary	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
Secondary	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
Secondary	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