WALANT in Distal Radius Fracture Osteosynthesis

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

COMPLETED

Clinical Phase

NA

Total Enrollment

27 participants

Study Classification

INTERVENTIONAL

Study Start Date

2020-12-20

Study Completion Date

2021-12-31

Brief Summary

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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.

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Detailed Description

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Conditions

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Radius Fracture Distal

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

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 Study Purpose

SUPPORTIVE_CARE

Blinding Strategy

DOUBLE

Participants Caregivers

10 block randomization was done by an external observer. Accordingly, the surgeon, the anesthesic or the patient didn't know about intervention until it was time to be exposed to the treatment

Study Groups

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WALANT

Wide awake local anesthesia without tourniquet was used for surgery

Group Type EXPERIMENTAL

WALANT

Intervention Type PROCEDURE

Wide awake local anesthesia without tourniquet for distal radius fracture surgery

Locoregional anesthesia and tourniquet

Locoregional anesthesia (normally axillary block) and tourniquet was used for surgery

Group Type ACTIVE_COMPARATOR

Locoregional anesthesia and tourniquet

Intervention Type PROCEDURE

Locoregional anesthesia and tourniquet for distal radius fracture surgery

Interventions

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WALANT

Wide awake local anesthesia without tourniquet for distal radius fracture surgery

Intervention Type PROCEDURE

Locoregional anesthesia and tourniquet

Locoregional anesthesia and tourniquet for distal radius fracture surgery

Intervention Type PROCEDURE

Eligibility Criteria

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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

Minimum Eligible Age

18 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

Yes