Spinal Anesthesia With Hyperbaric Levobupivacaine 0.75% for Ambulatory Knee Arthroscopy: A Double Blind, Randomized Clinical Trial Comparing Three Low Doses
试验速览
- 阶段
- 4 期
- 状态
- 已完成
- 发起方
- 入组人数
- 180
- 试验地点
- 1
- 主要终点
- Probability of Motor Block
研究概览
简要总结
The purpose of this study is to evaluate motor block probability throughout time and clinical profile when using three different doses of HLBP 0.75% (7.5, 9.37 and 11.25 mg) by a unilateral spinal block technique.
详细描述
Previous IRB approval and informed consent, 180 ASA I-II adults under ambulatory knee arthroscopy will be randomly allocated to receive unilateral spinal anesthesia with 7.5 (group Levo-7.5, n=59), 9.37(group Levo-9.37, n=61) and 11.25 (group Levo-11.25, n=60) mg of HLBP 0.75% using a 27-gauge Whitacre needle at a rate of 0.1 ml/ seg. and lateral decubitus position maintained for 5 min after injection.
An independent observer will evaluate motor (modified Bromage scale) and sensory (transcutaneal electrical stimulation at T10, L1, L3, and S1 dermal segments) levels and presence of adverse events immediately after return to supine, at the end of surgery and each 10 min from admission to PACU until home discharge conditions.
Trans-cutaneal electrical stimulation (TES) will be made with a PNS (Ministim® model MS- IV, Organon, Dublin, Irland) using 50-Hz tetanus stimuli for 5 seg. from 10 to 60 mA 3,4.
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, Investigator, Outcomes Assessor)
入排标准
- 年龄范围
- 18 Years 至 64 Years（Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Patients aged 18-64 y.o. scheduled for knee arthroscopy (therapeutic or diagnostic)
排除标准
- •Cardiac or pulmonary disease
- •Antiplatelet or anticoagulant drugs use during 7 days before surgery
- •History of coagulative disorders
- •Bilateral procedures
研究组 & 干预措施
Levo-7.5 mg
Hyperbaric Levobupivacaine 0.75% Spinal Administration by a Whitacre Needle 27G. Dosage: 7.5 mg. Single Dose.
干预措施: Hyperbaric Levobupivacaine 0.75% (Drug)
Levo-9.37
Hyperbaric Levobupivacaine 0.75% Spinal Administration by a Whitacre Needle 27G. Dosage: 9.37 mg. Single Dose.
干预措施: Hyperbaric Levobupivacaine 0.75% (Drug)
Levo-11.25
Hyperbaric Levobupivacaine 0.75% Spinal Administration by a Whitacre Needle 27G. Dosage: 11.25 mg. Single Dose.
干预措施: Hyperbaric Levobupivacaine 0.75% (Drug)
结局指标
主要结局
Probability of Motor Block
时间窗: 200 minutes
Likelihood Rate of motor block persistence after a dosis of spinal HLBP 0.75%
次要结局
- Failed Spinal Block Rate(15 minutes after dose)
研究者
Fredy Ariza
Anesthesiologist, Epidemiologist
Fundacion Clinica Valle del Lili