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Completed

NCT Number: NCT05421000

WALANT in Distal Radius Fracture Osteosynthesis

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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Key information

Conditions

Radius Fracture Distal Arm Injuries Fractures, Bone Wounds and Injuries Wrist Fractures Wrist Injuries

Age range

18 year and older

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

Hospital Arnau Vilanova

Lleida, Segria, 25198, Spain

Who can participate

Healthy volunteers accepted: Yes

Only the study team can determine whether someone qualifies for participation.

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

  • Unsigned informed consent
  • 17 years old or younger
  • Associated fractures in which additional osteosynthesis was required: scaphoid fracture, ulnar fracture (ulnar styloid osteosynthesis included), bifocal radius fractures, etc
  • Open fractures
  • Polytrauma patients
  • Requiring more than a standard volar DRF approach and/or other than a volar plate.
  • 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:

  • Existence of previous trauma or anatomical distortion of the area that prevents the abduction of the arm
  • Active presence of infection at the locoregional anesthesia puncture site
  • Previous axillary lymphadenopathy
  • Previous history of local anesthetic allergy
  • Severe coagulopathy
  • Severe pre-existing neurological diseases in the upper extremity

Contraindications for WALANT anesthetic technique

  • Documented hypersensitivity to lidocaine
  • Compromised peripheral circulation
  • Patients with previous vascular pathology, a history of vasculitis, Buerger's disease, and scleroderma
  • Patients with infection of the area surrounding the injection

Treatment and study plan

WALANT

Procedure

Wide awake local anesthesia without tourniquet for distal radius fracture surgery

Locoregional anesthesia and tourniquet

Procedure

Locoregional anesthesia and tourniquet for distal radius fracture surgery

Primary outcomes

  1. 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

    Time frame: Baseline, 24 hours after surgery, between 10 and 15 days after surgery, 1 month follow up

    Pain using Visual Analogue Scale (VAS) scale and analgesia used (1 to 10 score. 10 means worst pain possible, 1 is almost no pain)

  2. Change in baseline wrist swelling with 24 hours after surgery, between 10 or 15 days after surgery and at 1 month after surgery.

    Time frame: Baseline, 24 hours after surgery, between 10 and 15 days after surgery, 1 month follow up

    Difference between preoperative and postoperative swelling. Swelling was measured as Proximal wrist crease perimeter (cm). Healthy wrist was also measured to allow comparison.

  3. Patient satisfaction

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

    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)

Secondary outcomes

  1. Evolution of active bleeding through surgical wound after surgery

    Time frame: 24 hours after surgery, between 10 and 15 days after surgery, 1 month follow up

    Presence of active bleeding through the surgical wound

  2. Evolution in postoperative thumb mobility

    Time frame: 24 hours after surgery, between 10 and 15 days after surgery, 1 month follow up

    Kapandji scale for thumb mobility (1 to 10 scale. 10 represents the best thumb mobility and opposition possible, while 1 is almost no mobility)

  3. Difficulty in visualization of surgical field

    Time frame: During surgery

    Asked by the external observer to the surgeon right after the surgery had finished. Personal scale (1 easy- 5 very difficult)

  4. Stress during surgery

    Time frame: 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.

  5. Number of complications after surgery

    Time frame: Collected at end of follow up (1 month)

    Description of complications regarding surgery or anesthetical technique

  6. Evolution in postoperative finger mobility

    Time frame: 24 hours after surgery, between 10 and 15 days after surgery, 1 month follow up

    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)

  7. Evolution of surgical wound bleeding after surgery

    Time frame: 24 hours after surgery, between 10 and 15 days after surgery, 1 month follow up

    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)

  8. Evolution in postoperative wrist mobility

    Time frame: 24 hours after surgery, between 10 and 15 days after surgery, 1 month follow up

    Flexion, extension, radial and ulnar deviation, pronation and supination using a goniometer (º)

  9. Number of patients who need reconversion to general anaesthesia due to lack of effectiveness of anaesthetic technique

    Time frame: During surgery

    Yes or no answer to the question "does the patient need reconversion to general anaesthesia?"

  10. Number of patients who need adding some extra anaesthesia due to lack of effectiveness of anaesthetic technique

    Time frame: During surgery

    Yes or no answer to the question "does the patient need extra anaesthesia?"

  11. Description of reason why the patient needs adding some extra anaesthesia if necessary due to lack of effectiveness of the main anaesthetic technique

    Time frame: During surgery

    Open answer question describing the reason of anaesthesia insufficiency (for instance: pain, anxiety, discomfort, etc)

  12. Type of anaesthetic technique added to solve the lack of effectiveness of the main anaesthesia

    Time frame: During surgery

    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)

Sponsors and collaborators

Lead sponsor

Hospital Arnau de Vilanova

Other

Collaborators

  • Institut de Recerca Biomèdica de Lleida

Registry information

Official study title

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

Important dates

Study start
2020
Primary completion
2021
Study completion
2021
First posted
Jun 16, 2022
Registry last updated
Jun 16, 2022

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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