Continuous Sciatic Nerve Block vs Epidural Analgesia in Lower Limb Amputation for Prevention of Acute Postoperative Pain and Phantom Limb Pain: A Triple-blind Randomized Controlled Non-inferiority Clinical Trial.
试验速览
- 阶段
- 3 期
- 状态
- 尚未招募
- 入组人数
- 112
- 试验地点
- 1
- 主要终点
- Posoperative Pain
研究概览
简要总结
Controlled clinical trial of two parallel groups, with random assignment 1:1, non-inferiority, blinded for the patient, for who administers the intervention and for who analyzes the data. 112 participants
详细描述
Controlled clinical trial of two parallel groups, with random assignment 1:1, non-inferiority, blinded for the patient, for who administers the intervention and for who analyzes the data. 112 participants Outcomes: Primary: Numeric rating scale (NRS) ranging from 0 (no pain) to 10 (worst imaginable pain) was used for pain assessments daily for 15 days and subsequently monthly until completing 3 months. Co-primary: Assessment of symptomatology related to phantom limb pain daily for 15 days POP and subsequently monthly until completing 3 months.
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Parallel
- 主要目的
- Prevention
- 盲法
- Triple (Participant, Care Provider, Outcomes Assessor)
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 over 18 years
- •Being scheduled for above or below knee amputation or for bone remodeling of lower limb amputees
- •Acceptance of continuous regional analgesic technique as part of their multimodal analgesia
排除标准
- •Traumatic cause of amputation
- •Allergy to local anesthetics
- •Contraindication for epidural technique or continuous blocks
- •Stage 5 kidney disease
- •Concomitant use of aspirin and clopidogrel
- •Pregnancy status
研究组 & 干预措施
Epidural catheter
Epidural catheter infusion of bupivacaine 0.1% (4-6 cc/h) at level L3-L4
干预措施: Epidural catheter (Drug)
Continuous sciatic nerve block
Continuous sciatic catheter infusion of bupivacaine 0.1% (6-10 cc/h)
干预措施: Continuous sciatic nerve block (Drug)
结局指标
主要结局
Posoperative Pain
时间窗: 3 months
Pain score according to the daily NRS scale (Numeric Pain Rating Scale), Numeric Pain Rating Scale, for 15 days POP and subsequently monthly until completing 3 months. is scores from 0 to 10, 10 being the worst value.
Phantom Limp Pain
时间窗: 3 months
For this qualitative dichotomous outcome, you will ask about symptomatology referring to phantom limb pain for 15 days POP and subsequently monthly until completing 3 months, It will be qualified as positive if it presents any neuropathic symptom.
次要结局
- Opioid Consumption(36 hours)
- Phantom Limp Pain first Year(1 year)
- Incidence of nausea and vomiting POP(36 hours)
- Incidence of adverse effects(1 year)
- Days of hospital stay(during the time of hospitalization, on average 10 days)
- Mortality(1 year)