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Fixation of distal radius fractures using wide-awake local anaesthesia with no tourniquet (WALANT) technique

Aims We hypothesized that the wide-awake local anaesthesia with no tourniquet (WALANT) technique is cost-effective, easy to use, safe, and reproducible, with a low learning curve towards mastery, having a high patient satisfaction rate. Furthermore, WALANT would be a suitable alternative for the austere and developing nation environments where lack of funds and resources are a common issue. Methods This was a randomized control trial of 169 patients who required surgery for closed isolated distal radius fractures. The study was performed between March 2016 and April 2019 at a public sector level 1 trauma centre. General anaesthesia was used in 56 patients, Bier’s block in 58 patients, and WALANT in 55 patients. Data were collected on pre-, peri-, and postoperative parameters, clinical outcome, hospital costs, and patient satisfaction. One-way analysis of variance (ANOVA) was used with a p-value of 0.05 being significant. Results Operations with WALANT proceeded sooner, and patients recovered faster, resulting in mean fewer missed working days (7.8 (SD 1.67)) compared with general anaesthesia (20.1 (SD 7.37)) or Bier’s block (14.1 (SD 7.65)) (p < 0.001). The WALANT patients did not develop complications, while the other patients did (p < 0.04). Clinical outcomes did not differ, nor did surgeon qualification affect clinical outcomes. Mean hospital costs were lower for WALANT ($428.50 (SD 77.71)) than for general anaesthesia ($630.63 (SD 114.77)) or Bier’s block ($734.00 (SD 37.54)) (p < 0.001). Patient satisfaction was also higher (p < 0.001). Conclusion WALANT for distal radius fractures results in a faster recovery, is more cost-effective, has similar clinical outcomes, and has fewer complications than general anaesthesia or Bier's block. This makes WALANT an attractive technique in any setting, but especially in middle- and low-income countries. Cite this article: Bone Joint Res 2020;9(7):429–439.


Introduction
Distal radius fractures are among the most common types of injuries encountered in orthopaedic traumatology and represent 17.5% of all fractures in the emergency department. 1 Fractures of the distal radius follow a bimodal pattern and are mainly found in children, active young adults following a high-energy trauma, and -as a result of osteoporosis -in the elderly. 2 They are treated with either splint stabilization or, for fractures that are unstable or cannot be treated with a cast, with surgery. Since distal radius fractures hinder activities of daily life and thus affect an individual's financial circumstances, early surgical intervention is also adopted to treat patients with high demand of the use of their hands such as musicians, writers, and doctors, and of patients with high demand of the use of their time such as business executives.
The surgery can be performed under regional blocks such as brachial plexus block or Bier's block, or under general anaesthesia, while a tourniquet is applied to control haemostasis. However, applying blocks can be challenging and requires a high skillset, while in general anaesthesia patients' optimization is a prerequisite and sedation itself carries risks. Therefore, a new method of anaesthesia was developed by Bezuhly et al, 3 which is widely known by hand surgeons as wide-awake local anaesthesia with no tourniquet (WALANT).
This local anaesthesia technique can be safely performed in an out-patient setting for hand surgery and requires no tourniquet or sedation, only injection of lidocaine and epinephrine in the surgical field. 4,5 The lidocaine is for anaesthesia, and the epinephrine provides haemostasis, which deletes the need for a tourniquet. In addition, this technique has the advantage that it can be used in patients who are normally denied surgery because of age, comorbidities, or other contraindications. The technique does not require stringent intraoperative monitoring and has been shown to improve results, cost-effectiveness by reducing the extensive preoperative workup before surgery, and patient satisfaction for various types of hand surgery by eliminating tourniquetrelated pain. [6][7][8][9] Due to these advantages, the WALANT technique has quickly become a widely used anaesthesia technique for hand surgery. 10,11 The WALANT technique has only recently been applied for distal radius fractures. [12][13][14] For distal radius fractures, one might assume that the same advantages of WALANT exist as for hand surgery, but this has not been extensively investigated. Only one article, by Huang et al, 15 has so far compared the use of WALANT for distal radius fractures with another anaesthesia technique. In that study, perioperative parameters and clinical outcomes were compared between WALANT and general anaesthesia with a tourniquet in 47 patients. They found that the operation could begin much sooner with WALANT than with general anaesthesia. Although WALANT led to greater blood loss, this was a small amount that did not raise concern. The most important advantages of WALANT were that it led to less postoperative pain and shorter hospitalization. 15 We hypothesized that WALANT for distal radius fractures is cost-effective, easy to use, safe, and has a high patient satisfaction rate compared with the current practices of anaesthesia (general anaesthesia and Bier's block). Furthermore, we hypothesized that WALANT is a reproducible technique and does not require a high skillset. To test these hypotheses, we compared various perioperative parameters, clinical outcome, and costs of general anaesthesia, Bier's block, and WALANT techniques in a prospective cohort study.

Methods
A randomized controlled study with the intention to treat was conducted to compare various perioperative parameters, clinical outcome, and costs between three anaesthesia options (WALANT, general anaesthesia, and Bier's block) for surgery of distal radius fractures ( Figure 1). The study was conducted at a public sector tertiary care level 1 trauma centre between March 2016 and April 2019. The study protocol was approved by the medical ethics review (institutional review board (IRB) approval: NO.F.2 to 81/GENL-2016/11183Ab/JPMC) and all procedures followed were in accordance with the Helsinki declaration. The study was registered in an open access registry, namely the Chinese Clinical Trial registry under the trial number ChiCTR1900026870. Study design. A total of 169 patients with an isolated closed fracture of the distal radius who presented to our hospital within ten days of the initial injury were included; the demographics of the cohorts are stated in Table I. Exclusion criteria consisted of open fractures of the distal radius, bilateral distal radius fractures, active infection in the body, and certain contraindications to WALANT as expressed in Table II. Anteroposterior and lateral radiographs of the wrist were obtained on the first presentation to the orthopaedic emergency department, and the fracture was classified according to the Orthopaedic Trauma Association (OTA) classification system. 16 Patients were informed about the conservative and surgical treatment options, and patients opting for operative management were further informed about the trial and the risks of the surgery, including the three anaesthesia options (general anaesthesia, Bier's block, and WALANT). The fitness of patients for surgery was determined by the anaesthesiologist before the operation, based on the classification system of the American Society of Anesthesiologists (ASA). 17,18 A system-generated randomization algorithm was created by the research office and delivered by a dedicated officer to ensure that the allocation sequence was concealed. The individual patient was allocated treatment on a non-probability consecutive basis. When a patient entered the trial, a serial number was allotted to the patient. Double blinding technique was used and neither surgeon nor patient knew the intervention to be used prior to surgery; this was revealed in the operating theatre just before the surgery. The power of the study was kept at 80%.
The primary outcomes of the study were the patient's experience of pain and cost-effectiveness, which were divided into direct cost of the procedure and indirect cost along with the patient's intraoperative and postoperative experience, whereas the secondary outcomes were to compare the functional results of the surgery and patient satisfaction. The tertiary outcome was to investigate the reproducibility of the WALANT technique by comparing results of senior surgeons with the trainees. Surgical technique -WALANT. Patients undergoing WALANT were briefed about the procedure in detail, especially about the multiple skin pricks for WALANT solution infiltration, the possibility of converting to general anaesthesia, and the application of a tourniquet if haemostasis was not adequate. The patients were warned about the risk of the vasoconstrictive effect of epinephrine concerning digital ischaemia. We used the haematoma block method, for which 3 ml to 5 ml of 2% plain lidocaine was initially injected through the dorsal aspect of the fracture. For every 50 ml of WALANT solution we used 0.9% normal saline and 2% lidocaine with 1:1,000,000 concentration of epinephrine at a ratio of 1:1 ( Figure 2). The surface anatomy of the flexor carpi radialis (FCR) tendon was identified by radially deviating the wrist, and points were marked on the skin. In the same manner, the distal third of the radius was palpated, and four skin points were marked 2 cm apart starting from the distal wrist crease (Figure 3a). Proposed identification marks were prepared with povidone and chlorhexidine for subcutaneous local anaesthesia administration, according to the maximum safe dosage of 7 mg/kg/ml. The fractured site was sterilized and prepared for surgery while the surgeon (MT, GM, EAC) waited for the haemostatic effect; surgery started when 30 minutes had passed since the administration of the WALANT solution or when the visual analogue scale (VAS) was zero, 18 or whichever came first (Figures 3b and 3c).
In order to decrease the patient's level of anxiety during the surgery, one dedicated staff member of the operating team (MT, GM, KA, EAC) was designated to provide distractive anaesthesia to the patient by talking and providing distraction, especially during the drilling of the periosteum. Henry's approach was used in all cases and the procedure started with a longitudinal incision over the volar wrist. 19 Pronator quadratus (PQ) was exposed afteridentification, and the FCR and flexor pollicis longus (FPL) were retracted towards the ulna.
An additional 5 ml of the WALANT solution was injected beneath the PQ to anaesthetize the periosteum, and the surgery was paused for approximately 30 seconds for the local anaesthesia to take effect ( Figure 3d). PQ was reflected from radial attachment for fracture reduction, plate placement, drilling, and screw fixations ( Figure 3e). Locking plates (Double Medical Technologies, Fujian, China) were used in all cases.
The patient's vital signs, bleeding, and VAS score were recorded every ten minutes throughout the surgery. Blood loss was calculated according to the amount of blood present in the suction container. Fracture reduction was checked under a fluoroscope, during which the patients were asked to actively flex and extend their wrists and fingers to examine the stability of the fixation and identify any tendon disorders before wound closure (Supplementary Video i). The skin was sutured with simple interrupted nylon 2 to 0 sutures (Ethicon, Johnson & Johnson, Somerville, New Jersey, USA) and a soft dressing was applied.
Surgical technique -general anaesthesia and Bier's block. Patients having general anaesthesia or Bier's block with a tourniquet underwent a series of preoperative examinations and an anaesthesia risk evaluation. After adequate preparation, the patients received general anaesthesia or Bier's block under careful monitoring by the anaesthetist. A pressure of 250 mm Hg was applied via a tourniquet to limit blood loss. Surgery was performed according to the same approach used for the patients having WALANT. Postoperative care. For all patients operated on, vital signs and VAS score were obtained every half-hour after the surgery and the patients were kept in the ward overnight and discharged the next day. After the tenth WALANT procedure, the protocol for WALANT changed to day care surgery and patients were discharged after eight hours unless patients insisted on staying overnight. After the change in the WALANT protocol patients were informed of the signs and symptoms of compartment syndrome, digital ischaemia, and discharge from the wound site, and they were instructed to report immediately to

Relative contraindication
Polytrauma patients the orthopaedic emergency bay of the hospital should any of these symptoms develop.
For each patient, oral tramadol 37.5 mg/325 mg acetaminophen combination tablets two times a day were prescribed as the protocol for postoperative pain control medication, along with calcium supplements. In all three groups the patients were encouraged to practice flexion and extension as per tolerance to pain, and none of the patients' wrists were immobilized.
The first follow-up visit was two weeks after the surgery. Follow-up was performed in the outpatient clinic along with a follow-up visit to the physiotherapist for range of movement and grip strengthening exercises. Fracture union was assessed radiologically with the union of three out of four cortices, the range of movement was recorded by a goniometer, and patient satisfaction was evaluated by 12-Item Short-Form Health Survey questionnaire (SF-12) 21,22 at six weeks and one year. For the functional evaluation of the wrist the quick Disabilities of the Arm, Shoulder, and Hand (qDASH) questionnaire, Mayo's score, and patient-rated wrist evaluation (PRWE) 23 were assessed at one year. [24][25][26] Patients were followed up for one year.
The patients were advised to take a minimum of five days of rest and were then allowed to resume work according to their convenience, and were enrolled in a continuous physical therapy programme. Since most of the patients were on daily wages, they were allowed to do light duty work if they demonstrated half of the grip strength compared with the contralateral wrist. However, extended rest was prescribed depending on clinical and subjective assessment and taking into consideration the nature of the patient's work. Composition of wide-awake local anaesthesia with no tourniquet (WALANT) solution mixed in ratio of 1:1. The objective outcomes included wrist extension and flexion, Mayo wrist score, grip strength in newtons, the qDASH questionnaire that was filled in by a doctor on the surgical team, and PRWE questionnaires that were filled in by the patients. Statistical analysis. All data were entered into a database and analyzed with SPSS v26 (IBM, Armonk, New York, USA). GraphPad Prism 8 (GraphPad Software, San Diego, California, USA) was used to analyze a subset of the data and prepare graphs. One-way analysis of variance (ANOVA) and independent-samples t-tests were used to compare continuous variables and chi-squared tests were used to compare categorical variables, as appropriate. A p-value of less than 0.05 was considered to be statistically significant.

Results
The WALANT technique proved to be safe and more costeffective than general anaesthesia and Bier's block, ergonomically and logistically. In addition, patients operated in the WALANT group experienced a faster recovery and had similar clinical outcomes at one year of follow-up compared with patients operated under general anaesthesia and Bier's block. Moreover, the results of this trial strongly suggest that the WALANT technique had a small learning curve towards mastery and when the patient's clinical outcomes were compared between junior and senior doctors no statistical significance was observed, and this further strengthened the notion that WALANT is a reproducible technique. Primary outcomes. A primary outcome of this study was cost-effectiveness. Operations with WALANT proceeded sooner than operations with other techniques (p < 0.001, one-way ANOVA), with a substantially higher percentage of patients having a poor physiology and higher anaesthesia risk prior to operation in the WALANT technique group than in either of the other two technique groups (p < 0.001, chi-squared test) (Table III). Similarly, the mean preparation time for the surgery was longer for the general anaesthesia group (33.7 minutes (SD 5.81)) and the Bier's block group (30.2 minutes (SD 4.67)) than for the WALANT group (23.0 minutes (SD 3.85)) (p < 0.001, one-way ANOVA). However, the operating time did not differ much between the techniques (p < 0.018, one-way ANOVA) while recovery time was significantly shorter for the WALANT technique (p < 0.001, one-way ANOVA) (Table III).
Due to pre-existing comorbid conditions and a higher ASA grade, postoperatively the anaesthetist decided to put five of the general anaesthesia and four of the Bier's block patients in an intensive care unit (ICU), while none of the WALANT patients required ICU stay (Table III).
The mean number of total days in the hospital was different between the three groups, with the general anaesthesia group, the Bier's block group, and the WALANT group staying for 1.2 (SD 0.78), 1.5 (SD 0.99), and 0.2 days (SD 0.50), respectively (p < 0.001, one-way ANOVA) (Table III).
The WALANT group consumed mean fewer analgesics and required mean fewer physiotherapy sessions (p < 0.001, one-way ANOVA) ( Table III). The decision to end the physiotherapy session was decided by a multidisciplinary meeting with the patient, which included the operating surgeon and the physiotherapist, and patients were instructed to carry physiotherapy exercises at home.
There was a significant difference in mean costs between the procedures (p < 0.001), with Bier's block costing most at $734.00 (SD 37.54), general anaesthesia $630.63 (SD 114.77), and the WALANT technique costed the least at $428.50 (SD 77.71) ( Table IV). Each of these costs included the costs of the implants, the costs of the actual operation, hospital stay, and follow-up visits. Of all 169 participants in the study, only 34 (20.1%) had an insurance policy that paid the costs, 66 participants (39.1%) had to pay out-of-pocket, and 69 (40.8%) relied on welfare (Table IV).
Aside from the hospital costs, the patients also lost days at work, which in most cases affected their income as the majority worked on daily wages. The number of days from the time of surgery to resumption of work differed significantly between the three groups (p < 0.001, oneway ANOVA) (Table IV). Since most people also lost working days from the time of injury to the operation, the mean total number of working days lost was even greater: 20.1 days (SD 7.37) for the general anaesthesia group, 14.1 days (SD 7.65) for the Bier's block group, but only 7.8 days (SD 1.67) for the WALANT group, and this difference was also significant (p < 0.001, one-way ANOVA) (Table IV).
Clinical effectiveness was another primary outcome of this study. During the operation the WALANT patients scored better on the intraoperative VAS (p < 0.001, independent-samples t-test), with a mean highest intraoperative VAS score of 3.5 (SD 0.78) compared with 4.4 (SD 1.04) for the Bier's block patients.
Likewise, 24 hours postoperatively the WALANT patients also scored better on the VAS with a mean score of 1.2 (SD 0.62) compared with 3.0 (SD 1.24) and 2.2 (SD 1.35) for the general anaesthesia and Bier's block patients, respectively (both p < 0.001, one-way ANOVA). The mean VAS score between the general anaesthesia and Bier's block groups differed only slightly (p < 0.02) (Table III).
Patient satisfaction with the procedure was highest for the WALANT group, both at six weeks and one year after the procedure (both p < 0.001, one-way ANOVA). When asked whether, should the situation arise, the patient would consider choosing the same anaesthesia procedure again for removal of implant or recommend the same procedure again to someone, 53 (96.4%) patients in the WALANT group said yes, compared with just 47 (83.9%) and 50 (86.2%) patients from the general anaesthesia and Bier's block groups, respectively (p < 0.001, chi-squared test) (Table IV). Secondary outcomes. Clinical outcomes did not differ between the three groups, nor did the time from operation to bone union (Table V). However, patients in the WALANT group had a higher mean intraoperative blood loss than patients in the other two groups (p < 0.001, one-way ANOVA) (Table III). Complications were encountered in three patients in the general anaesthesia group who developed attrition injury (one) and mild inflammation of the wound (two), and in three patients of the Bier's block group who developed tourniquet palsy (two) due to tight tourniquet application and local anaesthetic systemic (LAS) toxicity (one). No complications were observed in the WALANT group (Table III).
During the operation, it was decided that the anaesthesia procedure of four (6.90%) of the Bier's block patients and two (3.64%) of the WALANT patients had to be changed to general anaesthesia, due to anxiety. Tertiary outcomes. The qualification of the surgeon did not affect the clinical outcomes; of the 55 WALANT procedures, 20 were carried out by one of five consultants and 35 were carried out by one of five residents (Supplementary Table i).

Discussion
In this randomized controlled study, we found that the WALANT anaesthesia technique applied during operation on distal radius fractures leads to a faster recovery, is more cost-effective, has similar clinical outcomes, and has fewer complications than general anaesthesia or Bier's block. In addition, we found that patient satisfaction is much higher for WALANT than for general anaesthesia or Bier's block. Together, these factors make the WALANT technique an attractive alternative for patients who qualify for this technique.
The WALANT technique has been in use for hand and wrist surgery for a number of years, 7,10,11 and it was found that WALANT is much more cost-effective than general anaesthesia. In a USA study comparing the costs of WALANT versus general anaesthesia for carpal tunnel syndrome surgery, a mean saving of $1,320 on healthcare costs -which included anaesthesia cost, preoperative cost, and postoperative cost -was found. 27 No cost comparison has been reported yet for WALANT versus any other technique for surgery of distal radius fractures. In our study, hospital costs were determined among others by factors such as length of hospital stay, number of complications, and number of people in the operating room. These factors all turned out to be more favourable for the WALANT group and resulted in mean total hospital costs of $428.50 (SD 77.71).
The difference in cost between WALANT and general anaesthesia ($202.10), as well as between WALANT and Bier's block ($305.50), is considerable, although these differences are much smaller than the difference of $1,320 between WALANT and general anaesthesia for carpal tunnel syndrome, most likely because healthcare costs in Pakistan are in general much lower than those in the USA. 27 To put the mean total hospital cost range of $428.50 to $734.00 for the three procedures into perspective, it is relevant to know that the mean annual household income in 2016 in Pakistan was $651. 28 The WALANT technique was only last year reported as an anaesthesia option for surgery of distal radius fractures. [12][13][14] The technique and one case were first described by Ahmad et al, 12 and Orbach et al 13 subsequently described successfully operating on five cases. Orbach et al 13 concluded that the WALANT technique offers a simple and safe alternative to traditional anaesthetic techniques for surgery on distal radius fractures.
In a subsequent study on 47 patients comparing WALANT with general anaesthesia for distal radius fractures, Huang et al 15 found that the patients undergoing WALANT anaesthesia lost more blood than the general anaesthesia patients (23 ml vs 9 ml) but were in less pain, and that the clinical outcomes were the same. In addition, no complications for either technique were reported, making WALANT a feasible and effective technique to apply for surgery of distal radius fractures. 15 We also found that although WALANT patients lost more blood (23.4 ml) than the patients in the general anaesthesia and Bier's block groups (12 ml and 14 ml), the total amount lost was no reason for concern. In our study, the WALANT technique resulted in no complications compared with the general anaesthesia or Bier's block techniques (three and three, respectively). The WALANT technique is not difficult to perform, based on the reproducibility of the technique between consultants and residents (Supplementary Table i).
The three techniques resulted in similar clinical outcomes, but since the WALANT technique resulted in a faster recovery, WALANT may be an attractive alternative to general anaesthesia and Bier's block. The patients in the WALANT group lost fewer working days as they recovered faster from the operation but -most importantly -because the time from injury to operation was much shorter. One of the main reasons for early return to (light duty) work was the psychological empowerment of the patient during the WALANT procedure, as the patient was able to flex and extend the wrist intraoperatively; this created a placebo effect and empowered the patient.
In terms of cost-effectiveness, WALANT does not require the advanced skills or resources such as a portable ultrasound machine or an anaesthetist that are required for Bier's block, or the increased logistics that are necessary for general anaesthesia; it can be treated as local anaesthesia, which is cost-effective and resource-friendly to the hospital and the patient. As a result, the operation could often be scheduled on the same day.
Since the mean recovery time was shorter in the WALANT group, hospital costs and other costs for the patients were lower than those for the general anaesthesia and Bier's block groups. Due to this faster recovery, direct patient costs such as number of physiotherapy sessions and analgesics use were lower in the WALANT group. A very important cost factor for patients may have been the number of working days lost, as for most people in Pakistan loss of working days means loss of income.
Based on studies applying WALANT for hand and wrist surgery, it is known that patients operated on with the WALANT technique score high on patient satisfaction (reviewed in van Demark RE et al 29 ), with many (86%) saying they would choose the same technique again and 90% saying they would recommend it to a friend. 30 In our study, around 96% (n = 53) of the WALANT group said they would undergo the same procedure again if needed, as opposed to 83.9% (n = 47) and 86.2% (n = 50) for the general anaesthesia and Bier's block groups. Patient satisfaction was also Cross-sectional anatomy of the distal radius. significantly higher in the WALANT group at both six weeks and one year after surgery than in the other two groups.
Indeed, Huang et al 15 also addressed the same intervention as ours; however, the current study has a larger sample size, almost three times that of the aforementioned study. Furthermore, Huang et al 15 focused on clinical outcomes, whereas our study comprehensively addressed costs, patient satisfaction, and clinical outcomes in a more detailed manner.
In addition, WALANT is a novel technique for treating distal radius fractures, so there is a need for further studies of this technique. The literature still requires additional outcomes to establish its effectiveness. These factors warrant the publication of this study as level I evidence.
In conclusion, application of the WALANT technique for anaesthesia during surgery for distal radius fractures results in a faster recovery, is more cost-effective, has similar clinical outcomes, and has fewer complications than general anaesthesia or Bier's block. This makes WALANT an attractive anaesthesia technique in any setting and is a great skill for the surgeon to be equipped with. Patient satisfaction is also higher for WALANT, making it an overall attractive alternative.
The first limitations of the WALANT approach are patient selection and local anaesthesia administration. Furthermore, appropriate knowledge of the surface anatomy of the distal radius is an essential prerequisite for the success of the technique, as the administration of local anaesthesia depends on the anatomical relations, especially when infiltrating the periosteum for drilling. In this scenario, the radial artery is nearby, and by palpating the radial border and injecting lateral to the radial border injury to the radial artery can be avoided. Also, for the periosteal block to work effectively the needle should go under the periosteum without being removed, and by circumferentially moving the needle the dorsal and volar sides can be infiltrated using WALANT solution ( Figure 4). This would also minimize pain when manipulating the fracture near the ulnar border of the distal radius.
Secondly, patients should be counselled in details regarding the WALANT technique, especially multiple needle pricks. Also, in our experience extreme levels of anxiety should be considered as an absolute contraindication.
Finally, we stress patience and tolerance from the surgeons' side to be the key factor for a successful WALANT procedure, especially the importance of allowing 25 to 30 minutes before the commencement of surgery to establish adequate anaesthesia and vasoconstriction.

Supplementary material
Video showing the fixation of distal radius fracture under wide-awake local anaesthesia with no tourniquet (WALANT).