Chloroprocaine 3% - Epidural Anesthesia in Unplanned Caesarean Section
Condition: Unplanned Caesarean Section
Intervention: Chloroprocaine; Ropivacaine
Intervention description: The 20 mL epidural anaesthetic solution will be administered as follows: 5 mL of the study anaesthetic solution will be given epidurally and the block will be assessed after 2 minutes from the first injection using cold, pinprick and touch. Then intrathecal placement will be excluded and a further 15 mL of the study anaesthetic solution will be administered epidurally. Two minutes after the start of the second injection, the sensory block will be re-assessed using cold, pinprick and touch. In case of pain or discomfort a 6 mL epidural top-up of the same anaesthetic will be administered.; The 20 mL epidural anaesthetic solution will be administered as follows: 5 mL of the study anaesthetic solution will be given epidurally and the block will be assessed after 2 minutes from the first injection using cold, pinprick and touch. Then intrathecal placement will be excluded and a further 15 mL of the study anaesthetic solution will be administered epidurally. Two minutes after the start of the second injection, the sensory block will be re-assessed using cold, pinprick and touch. In case of pain or discomfort a 6 mL epidural top-up of the same anaesthetic will be administered.
Intervention MeSH terms: Ropivacaine; Chloroprocaine
Phase: Phase 3
Study type: Interventional
Primary purpose: Treatment
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
Enrollment: 16.0
Sex: Female
Minimum age: 18 Years
Healthy volunteers: No

Summary:

      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.
    

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.