Comparison of Epidural Chloroprocaine 3% and Ropivacaine 0.75% for Unplanned Caesarean Section in Labouring Women Who Have an Epidural Catheter in Situ
试验速览
- 阶段
- 3 期
- 状态
- 终止
- 发起方
- Sintetica SA
- 入组人数
- 16
- 试验地点
- 1
- 主要终点
- Time to the Onset of Anaesthesia
研究概览
简要总结
The study evaluate the quality of epidural anaesthesia and the safety of Chloroprocaine HCl 3% compared with Ropivacaine HCl 0.75% in patients with an epidural catheter in situ undergoing unplanned Caesarean section.
详细描述
Labouring women who have an epidural catheter in situ and established analgesia, in need of an unplanned Caesarean section, will be randomly allocated to receive either Chloroprocaine HCl 3% (T-group) or Ropivacaine HCl 0.75% (R-group) epidurally. Prior to the epidural injection, the patient will be transferred to the operating theatre. The local anaesthetic solution will be freshly prepared and 20 mL will be administered by epidural injection, according to the standard hospital procedures, as detailed in the "Study Schedule" section below. Time T0 is defined as the start time of the first epidural injection of the investigational product. In case of pain or discomfort, a 6 mL epidural top-up of the same anaesthetic, i.e. Chloroprocaine HCl 3% in T-group and Ropivacaine HCl 0.75% in R-group, will be administered. The anaesthesiologist(s) administering the anaesthetic and collecting the data will be blinded with respect to the treatment given to each patient.
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
- Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
入排标准
- 年龄范围
- 18 Years 至 —（Adult, Older Adult）
- 性别
- Female
- 接受健康志愿者
- 否
入选标准
- •Informed consent: Signed written informed consent before inclusion in the study (obtained from women fulfilling the criteria, only when effective analgesia has been established)
- •Sex, pregnancy status and age: Labouring women with singleton pregnancy, ≥ 18 years old
- •Epidural catheter: Previously sited epidural catheter
- •ASA physical status: I-II
- •Analgesia: Effective analgesia established following combined spinal epidural analgesia (CSE)
- •Term gestation: ≥ 36 weeks
- •Caesarean section: Unplanned Caesarean section category 2 or 3, according to Lucas Classification
- •Body Mass Index (BMI): ≤ 40 kg/m2
- •Full comprehension: ability to comprehend the full nature and purpose of the study, including possible risks and side effects; ability to co-operate with the investigator and to comply with the requirements of the entire study.
排除标准
- •Physical findings: Clinically significant abnormal physical findings which could interfere with the objectives of the study. Contraindications to epidural anaesthesia
- •ASA physical status: III-V
- •Further anaesthesia: Patients expected to require further anaesthesia
- •Epidural catheter: Epidural catheter failure (epidural catheter replacement required or inability to provide effective analgesia)
- •Pregnancy: Labouring women with multiple pregnancy
- •Caesarean section: Elective Caesarean section
- •Allergy: ascertained or presumptive hypersensitivity to the active principle and /or formulations ingredients; ascertained or presumptive hypersensitivity to the amide and ester-type anaesthetics
- •Diseases: significant history of renal, hepatic, gastrointestinal, cardiovascular, respiratory, skin, haematological, endocrine or neurological diseases that may interfere with the aim of the study; ascertained psychiatric diseases, eclampsia, antepartum haemorrhage, sepsis, blood coagulation disorders, insulin dependent diabetes mellitus, terminal kidney failure
- •Medications: Medication known to interfere with the extent of regional blocks (see chloroprocaine and ropivacaine SmPCs) for 2 weeks before the start of the study
- •Investigative drug studies: participation in the evaluation of any investigational product for 3 months before this study, calculated from the first day of the month following the last visit of the previous study
- •Drug, alcohol: history of drug or alcohol abuse
- •Plasma cholinesterase: Known plasma cholinesterase deficiency.
研究组 & 干预措施
Chloroprocaine
Chloroprocaine, 20 ml epidural anaesthetic solution administered according to the standard procedures of the hospital. In case of pain or discomfort, a 6 mL epidural top-up will be administered.
干预措施: Chloroprocaine (Drug)
Ropivacaine
Ropivacaine, 20 ml epidural anaesthetic solution administered according to the standard procedures of the hospital. In case of pain or discomfort, a 6 mL epidural top-up will be administered.
干预措施: Ropivacaine (Drug)
结局指标
主要结局
Time to the Onset of Anaesthesia
时间窗: Up to 1 hour after last epidural injection
The time from T0 (start time of the epidural injection) to complete loss of cold sensation to the metameric level T4 (block to T4), bilateral.
次要结局
- Intravenous Fluids(Up to 12 hours after surgery)
- Proportion of Patients Who Need Top-up Anaesthesia(Up to 2 hours after last epidural injection)
- Oximetry(Up to 12 hours after surgery)
- Electrocardiogram(Up to 12 hours after surgery)
- Total Dose of Atropine(Up to 2 hours after last epidural injection)
- Maximum Metameric Level of the Sensory Block(Up to 1 hrs after last epidural injection)
- Concomitant Medications(Up to day 3±1 after surgery)
- Neonatal Adverse Events(Up to day 3±1 after surgery)
- Quality of the Block(Quality of the block assessed between 10 and 20 minutes after the end of surgery)
- Proportion of Patients Who Need Supplementation of Opioids(Up to 2 hours after last epidural injection)
- Proportion of Patients Who Need General Anaesthesia(Up to 2 hours after last epidural injection)
- Discomfort and Pain During Surgery(Up to 2 hours after last epidural injection)
- Maternal Treatment-emergent Adverse Events(Up to day 3±1 after surgery)
- Pulse Rate(Up to 12 hours after surgery)
- Total Dose of Phenylephrine(Up to 2 hours after last epidural injection)
- Time From T0 to Loss Light Touch Sensation(Up to 1 hour after last epidural injection)
- Motor Block Assessment(Up to 12 hours after surgery)
- First Breakthrough Pain(Up to 12 hours after surgery)
- Neonate Apgar(1 and 5 minutes after birth)
- Foetal Hypoxic Stress(Up to 12 hours after surgery)
- Pain at the Site of Surgery(Up to 12 hours after surgery)
- Pain at the Site of Epidural Injection(Up to 12 hours after surgery)