Intervention: Ropivacaine
Trial phase: Phase 3
ATC code: N01BB09
SMILES: CCCN1CCCC[C@H]1C(=O)Nc1c(C)cccc1C
Sex: Female
Age groups: Adult | Older Adult
Healthy volunteers: No
Participants at risk: 8
Group description: 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.

Ropivacaine: 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.
Eligibility criteria:
Inclusion Criteria:

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.

Exclusion Criteria:

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.