Chloroprocaine 3% - Epidural Anesthesia in Unplanned Caesarean Section

Sintetica

Status and phase: Terminated; Phase 3

Conditions: Unplanned Caesarean Section

Treatments: Drug: Ropivacaine; Drug: Chloroprocaine

Study type: Interventional

Funder types: Industry

Identifiers

NCT02919072

CHL.3/01-2016

Details and patient eligibility

About

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.

Full description

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.

Enrollment: 16 patients

Sex: Female

Ages: 18+ years old

Volunteers: No Healthy Volunteers

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.

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: Quadruple Blind

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16 participants in 2 patient groups

Chloroprocaine

Experimental group

Description:

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.

Treatment:

Drug: Chloroprocaine

Ropivacaine

Active Comparator 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.

Treatment:

Drug: Ropivacaine