Selective Subarachnoid Anesthesia. Comparison of Hyperbaric Bupivacaine and Hyperbaric Prilocaine in Knee Arthroscopy and Inguinal Hernia Repair in Ambulatory Surgery
试验速览
- 阶段
- 4 期
- 状态
- 已完成
- 发起方
- 入组人数
- 119
- 试验地点
- 1
- 主要终点
- Length of stay in post-operative care unit (in minutes)
研究概览
简要总结
Selective spinal anesthesia is widely used for ambulatory surgery. Unilateral spinal anesthesia is a suitable option for ambulatory anesthesia as it is efficient and effective. Lidocaine has been the well-known choice for this procedure. However, it is associated to transient neurologic symptoms (TNS). Different anesthetic strategies for this procedure have been performed, for example, the use of small doses of long-acting agents and the use of additives such as opioids. The ideal local anesthetic should be lidocaine-like without risk of transient neurologic symptoms. We design and plan a randomised clinical trial to show if hyperbaric prilocaine 2% would be an alternative.
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Parallel
- 主要目的
- Treatment
- 盲法
- Triple (Participant, Care Provider, Investigator)
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
- •Patients with a scheduled knee arthroscopy
- •Patients with a scheduled inguinal hernioplasty
排除标准
- •Patient refusal to regional anesthesia
- •American Society of Anesthesiologists score risk equal or greater than 4
- •Body mass index greater than 32
- •Coagulopathy
- •Cutaneous infection at injection site
研究组 & 干预措施
Hyperbaric prilocaine 1%
Solution for injection. Intradural use. In order to obtain Prilocaine 1% we charge a syringe with 2 mL Prilocaine 2%, and we add 1 mL Saline solution (0.9%) and 1 mL Glucose solution (33%). Administer 3 mL of syringe contains in two minutes.
干预措施: Hyperbaric Prilocaine 1% (Drug)
Hyperbaric Bupivacaine 0.5%
Solution for injection. Intradural use. Charge a syringe with 1 mL of Bupivacaine (0.5%) and administer it in a minute.
干预措施: Hyperbaric bupivacaine 0.5% (Drug)
结局指标
主要结局
Length of stay in post-operative care unit (in minutes)
时间窗: Participants will be followed an average of 6 hours from surgical incision closure to accomplish discharge criteria to go home
Time in minutes from closing the surgical incision until to having criteria for discharge to home.
次要结局
- Level of motor blocking(At surgical incision and at 60 minutes after anesthesia)
- Fast-track (by-pass recovery area)(Participants will be assessed when surgical incision is closed with surgical staples)
- Peak sensory block level(One minute before surgical incision)
- Transient neurological symptoms(At hospital discharge (an average of 8 hours after admission), and at home at 24, 48 and 72 hours after surgery)
研究者
Dr. Pere Roura-Poch
Head of Clinical epidemiology department
Consorci Hospitalari de Vic