EUCTR2016-000298-20-DEActive, not recruitingPhase 1
Comparison of epidural Chloroprocaine 3% and Ropivacaine 0.75% forunplanned Caesarean section in labouring women who have an epiduralcatheter in situ - Chloroprocaine 3% - Epidural
Conditions
Drugs
Trial Snapshot
- Phase
- Phase 1
- Status
- Active, not recruiting
- Sponsor
- Sintetica S.A.
- Enrollment
- 96
Study Overview
Brief Summary
No summary available.
Study Design
- Study Type
- Interventional clinical trial of medicinal product
Eligibility Criteria
- Sex
- All
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 (4)
- •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 cooperate
- •with the investigator and to comply with the requirements of the entire study.
- •Are the trial subjects under 18? no
- •Number of subjects for this age range:
- •F.1.2 Adults (18-64 years) yes
- •F.1.2.1 Number of subjects for this age range 96
- •F.1.3 Elderly (>=65 years) no
- •F.1.3.1 Number of subjects for this age range
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.
Investigators
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