Clinical trial NCT05421000: WALANT in Distal Radius Fracture Osteosynthesis
Official title: Assessing the Applicability and Potential Benefits of Wide Awake Local Anaesthesia No Tourniquet in Distal Radius Fracture Osteosynthesis.
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Radius Fracture Distal
Keywords: Radius Fracture Distal
Local Anesthesia
Brachial Plexus Anesthesia
Osteosynthesis, Fracture
Lead sponsor: Hospital Arnau de Vilanova
Sponsor class: OTHER
Collaborators: name: Institut de Recerca Biomèdica de Lleida
First posted: 2022-06-16
Enrollment: 27
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: yes
Allocation: RANDOMIZED
Intervention model: PARALLEL
Intervention 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.
Primary purpose: SUPPORTIVE_CARE

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.


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:

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

Primary outcomes:
measure: 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
timeFrame: Baseline, 24 hours after surgery, between 10 and 15 days after surgery, 1 month follow up
measure: Change in baseline wrist swelling with 24 hours after surgery, between 10 or 15 days after surgery and at 1 month after surgery.
timeFrame: Baseline, 24 hours after surgery, between 10 and 15 days after surgery, 1 month follow up
measure: Patient satisfaction
timeFrame: Written down in a questionnaire form delivered and answered by the patient between 10 and 15 days after surgery.
Secondary outcomes:
measure: Evolution of active bleeding through surgical wound after surgery
timeFrame: 24 hours after surgery, between 10 and 15 days after surgery, 1 month follow up
measure: Evolution in postoperative thumb mobility
timeFrame: 24 hours after surgery, between 10 and 15 days after surgery, 1 month follow up
measure: Difficulty in visualization of surgical field
timeFrame: During surgery
measure: Stress during surgery
timeFrame: During surgery
measure: Number of complications after surgery
timeFrame: Collected at end of follow up (1 month)
measure: Evolution in postoperative finger mobility
timeFrame: 24 hours after surgery, between 10 and 15 days after surgery, 1 month follow up
measure: Evolution of surgical wound bleeding after surgery
timeFrame: 24 hours after surgery, between 10 and 15 days after surgery, 1 month follow up
measure: Evolution in postoperative wrist mobility
timeFrame: 24 hours after surgery, between 10 and 15 days after surgery, 1 month follow up
measure: Number of patients who need reconversion to general anaesthesia due to lack of effectiveness of anaesthetic technique
timeFrame: During surgery
measure: Number of patients who need adding some extra anaesthesia due to lack of effectiveness of anaesthetic technique
timeFrame: During surgery
measure: Description of reason why the patient needs adding some extra anaesthesia if necessary due to lack of effectiveness of the main anaesthetic technique
timeFrame: During surgery
measure: Type of anaesthetic technique added to solve the lack of effectiveness of the main anaesthesia
timeFrame: During surgery
Other outcomes:
Locations:
city: Lleida
country: Spain
facility: Hospital Arnau Vilanova
state: Segria
Study officials:
affiliation: Hospital Arnau Vilanova
name: Ana Scott-Tennent, Miss
role: PRINCIPAL_INVESTIGATOR
References: