Intrathecal Use of Chloroprocaine 1% and Ropivacaine 0,75% During Elective Cesarean Section. A Comparative Study
试验速览
- 阶段
- 不适用
- 状态
- 招募中
- 入组人数
- 60
- 试验地点
- 1
- 主要终点
- level of sensory block every 15 min
研究概览
简要总结
This will be a prospective randomized study, aiming at comparing an intrathecal fixed dose of chloroprocaine 1% versus an intrathecal fixed dose of ropivacaine 0.75% in elective cesarean sections
详细描述
Neuraxial techniques are the anesthetic techniques of choice in contemporary obstetric anesthesia practice, with a definitive superiority as compared to general anesthesia, since, by their use, serious complications involving the airway can be avoided. Combined spinal-epidural anesthesia has become the favorable technique for both elective and emergency cesarean sections. Various local anesthetics have been used, but ropivacaine is the drug of choice in most hospitals in Greece. However, chloroprocaine is a preferable local anesthetic in USA due to its quick and predictable onset of action. Chloroprocaine was initially used in 1980, but it became obsolete in those years due to neurological symptoms associated with its use caused mainly by the presence of sodium bisulfite and disodium ethylenediaminetetraacetate (EDTA) in the early formulations. Nowadays, new formulations of the drug without EDTA makes chloroprocaine safe for use.
The aim of the current randomized controlled trial will be to compare the effect of an intrathecal fixed dose of chloroprocaine versus an intrathecal fixed dose of ropivacaine in parturients subjected to elective cesarean section under combined spinal-epidural anesthesia.
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
- 18 Years 至 48 Years（Adult）
- 性别
- Female
- 接受健康志愿者
- 否
入选标准
- •adult parturients, American Society of Anesthesiologists (ASA) I-II,
- •singleton gestation>37 weeks
- •elective cesarean section
排除标准
- •American Society of Anesthesiologists (ASA) > III
- •age < 18 years
- •singleton gestation <37 weeks
- •Body Mass Index (BMI) >40 kg/m2
- •Body weight <50 kg
- •Body weight>100 kg
- •height<150 cm
- •height>180 cm
- •multiple gestation
- •emergency delivery
- •fetal abnormality
- •fetal distress
- •pregnancy-induced pathology such as preeclampsia, eclampsia, premature labor, placental abnormalities
- •pregnancy- induced diseases such as hepatic failure, pseudocholinesterase deficiency, neuromuscular diseases
- •lack of informed consent
- •contraindication for regional anesthesia such as thrombocytopenia, coagulation abnormalities, allergy to local anesthetics
研究组 & 干预措施
chloroprocaine group
intrathecal fixed dose of chloroprocaine 1%
干预措施: Chloroprocaine 1% Injectable Solution (Drug)
ropivacaine group
intrathecal fixed dose of ropivacaine 0.75%
干预措施: Ropivacaine 0.75% Injectable Solution (Drug)
结局指标
主要结局
level of sensory block every 15 min
时间窗: intraoperative
measurement of sensory block every 15 minutes from spinal anesthesia to the end of the surgery
pain at neonatal delivery
时间窗: intraoperative
pain at neonatal delivery using VAS scale, where VAS=0, no pain; VAS=10, worst pain imaginable
pain at peritoneal manipulation
时间窗: intraoperative
pain at peritoneal manipulation using VAS scale, where VAS=0, no pain; VAS=10, worst pain imaginable
pain at Post Anesthesia Care Unit (PACU) discharge
时间窗: 1 hour postoperatively
pain at Post Anesthesia Care Unit (PACU) discharge using VAS scale, where VAS=0, no pain; VAS=10, worst pain imaginable
Time from spinal anesthesia to T10 block (min)
时间窗: intraoperative
time required from spinal anesthetic injection to anesthetic block up to the 10th thoracic neurotome
Time from spinal anesthesia to T4 block (min)
时间窗: intraoperative
time required from spinal anesthetic injection to anesthetic block up to the 4th thoracic neurotome
Time of spinal anesthesia to Bromage =3
时间窗: intraoperative
time required from spinal anesthetic injection to complete motor block (Bromage scale=3, where Bromage=0, no block; Bromage=1, partial block; Bromage=2, almost complete block; Bromage=3, complete block
level of sensory block every 3 min
时间窗: intraoperative
measurement of sensory block every 3 minutes after spinal anesthesia during the first 15 minutes
highest level of sensory block
时间窗: intraoperative
measurement of the highest level of sensory block after intrathecal infusion of local anesthetic
time from spinal anesthesia to highest level of sensory block
时间窗: intraoperative
time from the performance of spinal anesthesia to the highest level of sensory block
duration of sensory block
时间窗: intraoperative
measurement of time required for the sensory block to regress from sensory level T4 to sensory level T12/L2
pain at surgical incision
时间窗: intraoperative
pain at skin incision using Visual Analogue Scale (VAS), where VAS=0, no pain; VAS=10, worst pain imaginable
pain at Post Anesthesia Care Unit (PACU) admission
时间窗: 1 hour postoperatively
pain at Post Anesthesia Care Unit (PACU) admission using VAS scale, where VAS=0, no pain; VAS=10, worst pain imaginable
need for rescue analgesia intraoperatively
时间窗: intraoperative
need for rescue analgesia during the operation, via epidural catheter or intravenously
Bromage scale every 3 min after spinal anesthesia
时间窗: intraoperative
measurement of bromage scale every 3 minutes after spinal anesthesia during the first 15 minutes
Bromage scale every 15 min
时间窗: intraoperative
measurement of bromage scale every 15 minutes from spinal anesthesia to the end of the surgery
duration of motor block
时间窗: 1 hour postoperatively
measurement of time required for bromage scale to regress from 3 to 0
duration of staying in PACU
时间窗: 2 hours postoperatively
duration of parturient stay in PACU
次要结局
- neonatal blood gases(1 minute post delivery)
- need for vasoconstrictor(intraoperative)
- need for atropine(intraoperative)
- incidence of drowsiness(intraoperative)
- incidence of discomfort(intraoperative)
- time from spinal anesthesia to rescue analgesia in PACU(2 hours postoperatively)
- Neonatal Apgar score at 5 minutes(1 minute post delivery)
- Neonatal Apgar score at 1 minute(1 minute post delivery)
- incidence of neonatal acidosis(1 minute post delivery)
- incidence of hypotension(intraoperative)
- incidence of bradycardia(intraoperative)
- incidence of dizziness(intraoperative)
- incidence of nausea/vomiting(intraoperative)
- need for rescue analgesia in PACU(2 hours postoperatively)
- incidence of shivering(intraoperative)
- incidence of neurological symptoms during hospital stay(5 days postoperatively)
- incidence of low back pain(2 months after discharge)
- time from spinal anesthesia to mobilization(2 days postoperatively)
- mother's satisfaction from anesthesia(1 day postoperatively)
- gynecologist's satisfaction(1 hour postoperatively)
- incidence of neurological symptoms 2 months after the operation(2 months after discharge)
研究者
Dr Kassiani Theodoraki
Professor of Anesthesiology
Aretaieion University Hospital