Comparison of low versus intermediate intravenous dexamethasone doses on rebound pain after ambulatory open foot surgery under popliteal sciatic nerve block: a double-blind clinical trial.
试验速览
- 阶段
- 4 期
- 状态
- 招募中
- 发起方
- 入组人数
- 180
- 试验地点
- 1
- 主要终点
- Incidence of rebound pain, defined as a score ≥7 on the Numerical Rating Scale (NRS) following recovery of sensory function after the sciatic nerve block. The NRS (0 = no pain; 10 = worst pain imaginable) will be assessed at 24, 48, and 72 hours postoperatively via telephone follow-up. Patients will be previously instructed on how to use the scale.
研究概览
简要总结
To compare the incidence of rebound pain following outpatient open foot surgery under popliteal sciatic nerve block between patients receiving low versus intermediate prophylactic intravenous doses of dexamethasone.
入排标准
- 年龄范围
- 18 years 至 65+ years（65+ Years, 18-64 Years）
- 接受健康志愿者
- 否
入选标准
- •Adult patients, ASA physical status I–III, scheduled for elective outpatient open orthopedic foot surgery performed under popliteal sciatic nerve block.
排除标准
- •Patients under 18 years of age.
- •Patients with ASA physical status greater than III.
- •Surgery not performed under regional anesthesia or cases with regional anesthesia failure.
- •Patients with Type 1 diabetes mellitus.
- •Patients undergoing treatment for chronic pain.
结局指标
主要结局
Incidence of rebound pain, defined as a score ≥7 on the Numerical Rating Scale (NRS) following recovery of sensory function after the sciatic nerve block. The NRS (0 = no pain; 10 = worst pain imaginable) will be assessed at 24, 48, and 72 hours postoperatively via telephone follow-up. Patients will be previously instructed on how to use the scale.
Incidence of rebound pain, defined as a score ≥7 on the Numerical Rating Scale (NRS) following recovery of sensory function after the sciatic nerve block. The NRS (0 = no pain; 10 = worst pain imaginable) will be assessed at 24, 48, and 72 hours postoperatively via telephone follow-up. Patients will be previously instructed on how to use the scale.
次要结局
- Time to Onset of Postoperative Pain: Defined as the time interval between the confirmed establishment of the sciatic nerve block and the first perception of pain at the surgical site. This outcome will be assessed through telephone follow-up calls at 24 hours, 48 hours, and, if necessary, 72 hours after the block (for outpatient surgery) to record the timing of pain onset and estimate the duration of sensory block.
- Adverse Events Related to Dexamethasone: Significant hyperglycemia (>180 mg/dl), defined by capillary blood glucose measurement prior to discharge. Surgical site infection or delayed wound healing, monitored during follow-up for up to 1 month postoperatively.
研究者
Javier Barrio
Scientific
Hospital Universitario Dr Peset Aleixandre