Neurological Events and Unforeseen Risks After Locoregional-anesthesia
试验速览
- 阶段
- 不适用
- 状态
- 招募中
- 发起方
- 入组人数
- 3,396
- 试验地点
- 4
- 主要终点
- Incidence of Composite Complications Following Single-Shot Locoregional Anesthesia
研究概览
简要总结
This is a multicenter, prospective, observational study aimed at determining the incidence of neurological and non-neurological complications following locoregional anesthesia procedures. The study will collect data on events such as nerve injury, hematoma, pneumothorax, and local anesthetic systemic toxicity.
详细描述
Locoregional anesthesia is generally considered safe, but rare neurological and systemic complications have been reported. Current data on the true incidence of these complications are limited and often derived from small sample sizes or registries. The NEURAL study aims to fill this knowledge gap by prospectively collecting data on complications following single-shot nerve blocks in the upper limb, lower limb, and fascial plane. In addition to incidence, the study will investigate potential risk factors for these complications.
研究设计
- 研究类型
- Observational
- 观察模型
- Cohort
- 时间视角
- Prospective
入排标准
- 年龄范围
- 18 Years 至 —（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Age ≥ 18 years.
- •Scheduled to undergo a single-shot nerve or fascial plane block.
- •Ability to provide written informed consent.
排除标准
- •Performance of more than one single-shot nerve or fascial plane block within the same anatomical region or sensory distribution during the same procedure.
- •Use of continuous nerve or fascial plane catheter-based anesthesia.
- •Presence of a language barrier that, in the investigator's judgment, would prevent adequate follow-up.
研究组 & 干预措施
Single group of enrolled patients
Adult patients (≥18 years) undergoing single-shot upper limb, lower limb, or fascial plane regional anesthesia. All participants meeting inclusion criteria and providing informed consent will be enrolled consecutively.
干预措施: Observational assessment after regional anesthesia (Other)
结局指标
主要结局
Incidence of Composite Complications Following Single-Shot Locoregional Anesthesia
时间窗: From the time of the locoregional anesthesia procedure up to 30 days post-procedure (periprocedural and early postoperative period, with follow-up at 24 hours, 48 hours, 15 days, and 30 days).
Incidence of any major complication - including nerve injury, hematoma requiring medical intervention, pneumothorax, or local anesthetic systemic toxicity (LAST) - following single-shot locoregional anesthesia. The rate is calculated as the number of procedures with at least one complication divided by the total number of procedures performed.
次要结局
- Incidence of Complications in Upper Limb Nerve Blocks(From the procedure to 30 days post-procedure.)
- Incidence of Complications in Fascial Plane Blocks(From the procedure to 30 days post-procedure.)
- (Predictor of Complications in Upper Limb, Lower Limb or Fascial Plane Blocks) Age(Baseline)
- (Predictor of Complications in Upper Limb, Lower Limb or Fascial Plane Blocks) Gender(Baseline)
- (Predictor of Complications in Upper Limb, Lower Limb or Fascial Plane Blocks) Body Mass Index(Baseline)
- (Predictor of Complications in Upper Limb, Lower Limb or Fascial Plane Blocks) Presence of comorbidities(Baseline)
- (Predictor of Complications in Upper Limb, Lower Limb or Fascial Plane Blocks) Pain at injection(Baseline)
- (Predictor of Complications in Upper Limb, Lower Limb or Fascial Plane Blocks) Ultrasound guidance(Periprocedural)
- (Predictor of Complications in Upper Limb, Lower Limb or Fascial Plane Blocks) Local anesthetic used to perform the block(Periprocedural)
- (Predictor of Complications in Upper Limb, Lower Limb or Fascial Plane Blocks) Adjuvants used to perform the block(Periprocedural)
- (Predictor of Complications in Upper Limb, Lower Limb or Fascial Plane Blocks) Use of anticoagulant or antiplatelet therapy(Baseline)
- (Predictor of Complications in Upper Limb, Lower Limb or Fascial Plane Blocks) Use of sedative during the block procedure(Periprocedural)