Determination of the Minimum Local Anesthetic Dose (MLAD) of Spinal Chloroprocaine for Inguinal Herniorrhaphy in Ambulatory Surgery
试验速览
- 阶段
- 4 期
- 状态
- 已完成
- 入组人数
- 12
- 主要终点
- The dose of chloroprocaine 1% needed for the individual patient for a sensory anesthesia block at or above the T6 dermatome
研究概览
简要总结
This study is to determine the minimum effective dose for intrathecal chloroprocaine in inguinal herniorrhaphy in outpatients using a Combined Spinal Epidural (CSE) anesthesia.
详细描述
A standard CSE procedure will be conducted in which the patient is placed in an upright sitting position on the side of the operation table and a epidural Tuohy needle 18G will be inserted into L3-L4 interspace via a loss-of-resistance technique. The dura will be punctured using a 27-gauge pencil-point spinal needle and a certain dose of chloroprocaine 1% will be given. After the spinal needle is withdrawn, an epidural catheter will be placed and the epidural needle will be withdrawn. After fixation of catheter the patient will be placed in a supine position.
The first spinal dose of chloroprocaine 1% to start with is 50mg. This dose has been successfully used for spinal anesthesia in hernia repair outpatients to reach an adequate analgesia. Each time there will be added 2,5 microgram of sufentanil for prolongation of the analgesia. The testing interval is 2 mg.
研究设计
- 研究类型
- Interventional
- 干预模型
- Sequential
- 主要目的
- Treatment
- 盲法
- None
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
- •Outpatients for unilateral inguinal hernia repair
- •ASA I - II - III
排除标准
- •hypersensitivity to amino-ester local anesthetics, para-aminobenzoic acid or sufentanil
- •contraindications to spinal or epidural anesthesia
- •bilateral inguinal herniorrhaphy
- •extremes of height and weight (BMI 20 or 35 kg/m2, height 150 cm or 185 cm)
研究组 & 干预措施
chloroprocaine 1% injectable solution
Prospective, up-down sequential allocation : first patient receives 50mg intrathecal chloroprocaine 1%.
An effective result will decrease the test dose of chloroprocaine with 2 mg for the next patient in this study.
An ineffective result will increase the test dose of chloroprocaine with 2 mg for the next patient in this study.
干预措施: Chloroprocaine 1% Injectable Solution (Drug)
结局指标
主要结局
The dose of chloroprocaine 1% needed for the individual patient for a sensory anesthesia block at or above the T6 dermatome
时间窗: start of surgery
MLAD of chloroprocaine 1% with 2,5 mcg of sufentanil needed for the individual patient required for a sensory anesthesia at or above the T6 dermatome at the beginning of surgery with no additional epidural anesthesia required during surgery
次要结局
- Time to micturition(From starting hour of spinal anesthesia to hour of first micturition after the end of surgery measured up to 6 hours after surgery)
- Time for regression of two segments(during surgery)
- Time to discharge(From starting hour of spinal anesthesia to hour of discharge from hospital measured up to 6 hours after surgery)
- Patient satisfaction with anesthesia method: questionnaire(postoperatively,at moment of hospital discharge measured up to 6 hours after surgery)
- Peak block height(during surgery)
- Ambulation time(From starting hour of spinal anesthesia to hour of first ambulation after the end of surgery measured up to 6 hours after surgery)
- Incidence of side effects (perioperative hypotension, respiratory depression, neurologic deficits)(perioperative)