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WALANT in Distal Radius Fracture Osteosynthesis

H

Hospital Arnau de Vilanova

Status

Completed

Conditions

Radius Fracture Distal

Treatments

Procedure: WALANT
Procedure: Locoregional anesthesia and tourniquet

Study type

Interventional

Funder types

Other

Identifiers

NCT05421000
CEIC-2360

Details and patient eligibility

About

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.

Enrollment

27 patients

Sex

All

Ages

18+ years old

Volunteers

Accepts Healthy Volunteers

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

Trial design

Primary purpose

Supportive Care

Allocation

Randomized

Interventional model

Parallel Assignment

Masking

Double Blind

27 participants in 2 patient groups

WALANT
Experimental group
Description:
Wide awake local anesthesia without tourniquet was used for surgery
Treatment:
Procedure: WALANT
Locoregional anesthesia and tourniquet
Active Comparator group
Description:
Locoregional anesthesia (normally axillary block) and tourniquet was used for surgery
Treatment:
Procedure: Locoregional anesthesia and tourniquet

Trial documents
2

Trial contacts and locations

1

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Data sourced from clinicaltrials.gov

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