WALANT in Distal Radius Fracture Osteosynthesis

NCT05421000 | Completed

• 1 other identifier: CEIC-2360
• Study Type: interventional
• Target: 27
• Locations: 1 country
• Sites: 1

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.

Conditions

Radius Fracture Distal

Keywords

Radius Fracture Distal; Local Anesthesia; Brachial Plexus Anesthesia; Osteosynthesis, Fracture

Outcome Measures

Primary Outcomes (3)

• 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

• 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

• 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 Outcomes (12)

• Evolution of active bleeding through surgical wound after surgery

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

• Evolution in postoperative thumb mobility

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

• Difficulty in visualization of surgical field

  During surgery

• Stress during surgery

  During surgery

• Number of complications after surgery

  Collected at end of follow up (1 month)

Study Arms (2)

WALANT

EXPERIMENTAL

Wide awake local anesthesia without tourniquet was used for surgery

Procedure: WALANT

Locoregional anesthesia and tourniquet

ACTIVE COMPARATOR

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

Procedure: Locoregional anesthesia and tourniquet

Interventions

WALANT PROCEDURE

Wide awake local anesthesia without tourniquet for distal radius fracture surgery

WALANT

Locoregional anesthesia and tourniquet PROCEDURE

Locoregional anesthesia and tourniquet for distal radius fracture surgery

Locoregional anesthesia and tourniquet

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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

You may not qualify if:

• Unsigned informed consent
• 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

Sponsors & Collaborators

• Hospital Arnau de Vilanova: lead
• Institut de Recerca Biomèdica de Lleida: collaborator

Study Sites (1)

Hospital Arnau Vilanova

Lleida, Segria, 25198, Spain

Location

MeSH Terms

Conditions

Wrist Fractures; Fractures, Bone

Interventions

Tourniquets

Condition Hierarchy (Ancestors)

Wrist Injuries; Arm Injuries; Wounds and Injuries

Intervention Hierarchy (Ancestors)

Equipment and Supplies

Study Officials

• Ana Scott-Tennent, Miss

  Hospital Arnau Vilanova

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: DOUBLE
• Who Masked: PARTICIPANT, CARE PROVIDER
• Masking Details: 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
• Purpose: SUPPORTIVE CARE
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Principal investigator. Orthopaedic surgeon in Upper Extremity department

Model Details: 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.

Study Record Dates

• First Submitted: June 1, 2022
• First Posted: June 16, 2022
• Study Start: December 20, 2020
• Primary Completion: December 22, 2021
• Study Completion: December 31, 2021
• Last Updated: June 16, 2022

Record last verified: 2022-06

Data Sharing

• IPD Sharing: Will not share

Locations

ES (1)