Radius Fracture Distal
Conditions
Keywords
Radius Fracture Distal, Local Anesthesia, Brachial Plexus Anesthesia, Osteosynthesis, Fracture
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.
Interventions
PROCEDUREWALANT
Wide awake local anesthesia without tourniquet for distal radius fracture surgery
PROCEDURELocoregional anesthesia and tourniquet
Locoregional anesthesia and tourniquet for distal radius fracture surgery
Sponsors
Institut de Recerca Biomèdica de Lleida
Hospital Arnau de Vilanova
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
SUPPORTIVE_CARE
Masking
DOUBLE (Subject, Caregiver)
Masking description
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
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.
Eligibility
Sex/Gender
ALL
Age
18 Years to No maximum
Healthy volunteers
Yes
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
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| 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 | 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) |
| Change in baseline wrist swelling with 24 hours after surgery, between 10 or 15 days after surgery and at 1 month after surgery. | 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. |
| Patient satisfaction | 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
| Measure | Time frame | Description |
|---|---|---|
| Stress during surgery | 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. |
| Number of complications after surgery | Collected at end of follow up (1 month) | Description of complications regarding surgery or anesthetical technique |
| Evolution in postoperative finger mobility | 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) |
| Evolution of surgical wound bleeding after surgery | 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) |
| Difficulty in visualization of surgical field | During surgery | Asked by the external observer to the surgeon right after the surgery had finished. Personal scale (1 easy- 5 very difficult) |
| Number of patients who need reconversion to general anaesthesia due to lack of effectiveness of anaesthetic technique | During surgery | Yes or no answer to the question does the patient need reconversion to general anaesthesia? |
| Number of patients who need adding some extra anaesthesia due to lack of effectiveness of anaesthetic technique | During surgery | Yes or no answer to the question does the patient need extra anaesthesia? |
| Description of reason why the patient needs adding some extra anaesthesia if necessary due to lack of effectiveness of the main anaesthetic technique | During surgery | Open answer question describing the reason of anaesthesia insufficiency (for instance: pain, anxiety, discomfort, etc) |
| Type of anaesthetic technique added to solve the lack of effectiveness of the main anaesthesia | 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) |
| Evolution in postoperative wrist mobility | 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) |
| Evolution of active bleeding through surgical wound after surgery | 24 hours after surgery, between 10 and 15 days after surgery, 1 month follow up | Presence of active bleeding through the surgical wound |
| Evolution in postoperative thumb mobility | 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) |
Countries
Spain
Outcome results
None listed