Assessing the Applicability and Potential Benefits of Wide Awake Local Anaesthesia No Tourniquet in Distal Radius Fracture Osteosynthesis.
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 发起方
- 入组人数
- 27
- 试验地点
- 1
- 主要终点
- 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
研究概览
简要总结
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.
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Parallel
- 主要目的
- Supportive Care
- 盲法
- Double (Participant, Care Provider)
盲法说明
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
入排标准
- 年龄范围
- 18 Years 至 —（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 是
入选标准
- •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
排除标准
- •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
研究组 & 干预措施
WALANT
Wide awake local anesthesia without tourniquet was used for surgery
干预措施: WALANT (Procedure)
Locoregional anesthesia and tourniquet
Locoregional anesthesia (normally axillary block) and tourniquet was used for surgery
干预措施: Locoregional anesthesia and tourniquet (Procedure)
结局指标
主要结局
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
时间窗: 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.
时间窗: 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
时间窗: 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)
次要结局
- 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))
- Evolution in postoperative finger mobility(24 hours after surgery, between 10 and 15 days after surgery, 1 month follow up)
- Evolution of surgical wound bleeding after surgery(24 hours after surgery, between 10 and 15 days after surgery, 1 month follow up)
- Evolution in postoperative wrist mobility(24 hours after surgery, between 10 and 15 days after surgery, 1 month follow up)
- Number of patients who need reconversion to general anaesthesia due to lack of effectiveness of anaesthetic technique(During surgery)
- Number of patients who need adding some extra anaesthesia due to lack of effectiveness of anaesthetic technique(During surgery)
- 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)
- Type of anaesthetic technique added to solve the lack of effectiveness of the main anaesthesia(During surgery)
研究者
Ana Scott-Tennent
Principal investigator. Orthopaedic surgeon in Upper Extremity department
Hospital Arnau de Vilanova