Chloroprocaine 3% - Epidural Anesthesia in Unplanned Caesarean Section

Launched by SINTETICA SA · Sep 27, 2016

Keywords

ClinConnect Summary

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 ...

Gender

FEMALE

Eligibility criteria

• Inclusion Criteria:
• • 1. Informed consent: Signed written informed consent before inclusion in the study (obtained from women fulfilling the criteria, only when effective analgesia has been established)
• • 2. Sex, pregnancy status and age: Labouring women with singleton pregnancy, ≥ 18 years old
• • 3. Epidural catheter: Previously sited epidural catheter
• • 4. ASA physical status: I-II
• • 5. Analgesia: Effective analgesia established following combined spinal epidural analgesia (CSE)
• • 6. Term gestation: ≥ 36 weeks
• • 7. Caesarean section: Unplanned Caesarean section category 2 or 3, according to Lucas Classification
• • 8. Body Mass Index (BMI): ≤ 40 kg/m2
• • 9. 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.
• Exclusion Criteria:
• • 1. Physical findings: Clinically significant abnormal physical findings which could interfere with the objectives of the study. Contraindications to epidural anaesthesia
• • 2. ASA physical status: III-V
• • 3. Further anaesthesia: Patients expected to require further anaesthesia
• • 4. Epidural catheter: Epidural catheter failure (epidural catheter replacement required or inability to provide effective analgesia)
• • 5. Pregnancy: Labouring women with multiple pregnancy
• • 6. Caesarean section: Elective Caesarean section
• • 7. Allergy: ascertained or presumptive hypersensitivity to the active principle and /or formulations ingredients; ascertained or presumptive hypersensitivity to the amide and ester-type anaesthetics
• • 8. 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
• • 9. 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
• • 10. 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
• • 11. Drug, alcohol: history of drug or alcohol abuse
• • 12. Plasma cholinesterase: Known plasma cholinesterase deficiency.