Addition of Lidocaine to Levobupivacaine Reduces Intrathecal Block Duration: Randomized Controlled Trial
试验速览
- 阶段
- 4 期
- 状态
- 已完成
- 入组人数
- 40
- 试验地点
- 1
- 主要终点
- The duration of the spinal block (S1 regression of the block)
研究概览
简要总结
The main objective was to test the hypothesis that adding lidocaine to hyperbaric levobupivacaine could change the duration of levobupivacaine spinal block.
详细描述
A satisfactory spinal anaesthesia requires both a fast onset and proper duration at the same time. Transurethral resection of the prostate (TUR-P) is a surgery of medium duration. The addition of lidocaine to hyperbaric bupivacaine shortens the duration of bupivacaine spinal block and therefore provides more rapid recovery. This property of lidocaine is not verified with other local anesthetics. Levobupivacaine is a S-enantiomer of racemic bupivacaine and is a long acting local anesthetic.The aim of this prospective randomized controlled study was to investigate this effect of lidocaine, with a local anesthetic other than bupivacaine. It was hypothesized that the duration of the intrathecal block could change when performed with hyperbaric levobupivacaine mixed with low dose lidocaine and this technique could be consistent for the duration of TUR-P surgery. Participants will be followed on the day of surgery for primary and secondary outcome measures and 3 days postoperatively for complications (TNS).
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
- Double (Participant, Outcomes Assessor)
入排标准
- 年龄范围
- 40 Years 至 80 Years（Adult, Older Adult）
- 性别
- Male
- 接受健康志愿者
- 否
入选标准
- •elective transurethral resection of the prostate (TUR-P)
排除标准
- •patients with contraindications for spinal anesthesia,
- •known sensitivity to the study drugs,
- •emergency cases, and
- •patients who refused spinal anaesthesia were excluded
研究组 & 干预措施
Group Levobupivacaine lidocaine
Group Levobupivacaine lidocaine Spinal anesthesia with 1.5 ml hyperbaric levobupivacaine (6.75 mg) + 0.3 ml 2 % lidocaine
干预措施: Levobupivacaine lidocaine spinal anesthesia (Drug)
Group Control
Group Control levobupivacaine spinal anesthesia with levobupivacaine (6.75 mg) + saline
干预措施: levobupivacaine Spinal anesthesia (Drug)
结局指标
主要结局
The duration of the spinal block (S1 regression of the block)
时间窗: participanta will be followed on the operation day
the time between the intrathecal injection and sensorial block regression to S1 dermatome, measured in minutes
次要结局
- postoperative care unit stay(participants will be followed on the operation day)
研究者
DILEK YAZICIOGLU
Principal investigator
Diskapi Teaching and Research Hospital