Spinal Anesthesia With Bupivacaine or 2-chloroprocaine for Outpatient Elective Surgery: a Prospective, Randomized, Double-blind Comparison.
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 入组人数
- 106
- 试验地点
- 1
- 主要终点
- Time to obtain discharge criteria from recovery room
研究概览
简要总结
The purpose of this study is to compare the efficacity and the readiness for discharge between two local anesthetics, bupivacaine and 2-chloroprocaine, used for spinal anesthesia.
详细描述
Many surgeries are performed under spinal anesthesia, including ambulatory surgeries. The standard agent used for spinal anesthesia is called bupivacaine. It's safe and effective, but has a major disadvantage. It has a long duration of action (up to 4 hours), witch can prolong unnecessarily the patient's stay in the recovery room and in hospital.
Another local anesthetic available for spinal anesthesia is 2-chloroprocaine. It has been used since many years, but some serious cases of toxicity in the 80's led to an interruption of its utilization. Those cases have been proven to be associated with the preservative agent (bisulfite) that was added and to the low pH (<3) of the drug.
Since then, 2-chloroprocaine exists in a preservative-free formulation and has been used in thousands of patients worldwide, without any problem. The major advantage of 2-chloroprocaine is its shorter duration of action, permitting a faster recovery from anesthesia, and also permitting a faster discharge from hospital (in a context of ambulatory surgery)
The purpose of this study is to compare the efficacity and the readiness for discharge (from the recovery room, and from hospital) between two local anesthetics, bupivacaine and 2-chloroprocaine, used for spinal anesthesia in elective ambulatory surgeries.
Patients, after consenting for the study, will be randomly assigned to the following groups:
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, 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 aged 18 years and older
- •urologic elective ambulatory procedure. For example:cystoscopy, circumcision,transurethral bladder tumor resection, varicocele and hydrocele surgery
- •gynecologic elective ambulatory procedure. For example: hysteroscopy, vulvar ou vaginal biopsy
- •general surgery elective ambulatory procedure. For example:inguinal herniorraphy, short ano-rectal procedure
排除标准
- •INR > 1,3
- •platelet < 75 000
- •concomitant drugs: clopidogrel (last dose < 7 days), iv heparin, low molecular weight heparin (last dose < 24 hours)
- •neurologic disease: spinal stenosis, symptomatic lumbar herniated disc, multiple sclerosis
- •liquid restriction (cardiac or renal insufficiency)
- •allergy or intolerance to chloroprocaine, bupivacaine or PABA
- •atypical plasma cholinesterase or deficiency
研究组 & 干预措施
Chloroprocaine
干预措施: chloroprocaine (Drug)
Bupivacaine
干预措施: bupivacaine (Drug)
结局指标
主要结局
Time to obtain discharge criteria from recovery room
时间窗: within the first hours (1-2 h) after the surgery
次要结局
- Time to obtain discharge criteria from hospital(within the same day of the surgery)
- The amount of additional IV analgesia (fentanyl) administered during the intraoperative period(total length of surgery)
- The amount of iv analgesia (fentanyl and morphine) needed in the recovery room(lenght of stay in the recovery room)