Chloroprocaine 3% - Epidural Anesthesia in Unplanned Caesarean Section

Phase 3

Terminated

Conditions: Unplanned Caesarean Section

Interventions: Drug: Chloroprocaine
Drug: Ropivacaine

Registration Number: NCT02919072

Lead Sponsor: Sintetica SA

Brief 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.

Detailed 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.

Recruitment & Eligibility

Status: TERMINATED

Sex: Female

Target Recruitment: 16

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.

Study & Design

Study Type: INTERVENTIONAL

Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
Chloroprocaine	Chloroprocaine	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.
Ropivacaine	Ropivacaine	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.

Primary Outcome Measures

Name	Time	Method
Time to the Onset of Anaesthesia	Up to 1 hour after last epidural injection	The time from T0 (start time of the epidural injection) to complete loss of cold sensation to the metameric level T4 (block to T4), bilateral.

Secondary Outcome Measures

Name	Time	Method
Proportion of Patients Who Need Top-up Anaesthesia	Up to 2 hours after last epidural injection	Proportion of patients who need top-up epidural anaesthesia (same anaesthetic as first epidural injection)
Oximetry	Up to 12 hours after surgery	Maternal pulse oximetry (SpO2)
Electrocardiogram	Up to 12 hours after surgery	Maternal electrocardiogram
Total Dose of Atropine	Up to 2 hours after last epidural injection	Total dose (mg) of atropine
Maximum Metameric Level of the Sensory Block	Up to 1 hrs after last epidural injection	Maximum metameric level of the sensory block assessed by three modalities (complete loss of cold, pinprick and light touch sensation)
Intravenous Fluids	Up to 12 hours after surgery	Total volume (ml) of intravenous fluids
Concomitant Medications	Up to day 3±1 after surgery	Maternal concomitant medications
Neonatal Adverse Events	Up to day 3±1 after surgery	Neonatal adverse events
Quality of the Block	Quality of the block assessed between 10 and 20 minutes after the end of surgery	Quality of the block assessed between 10 and 20 min after the end of surgery by the anaesthesiologist and patient together using a 0-10 cm visual analogue scale (VAS; 10=excellent anaesthetic quality, 0=very poor anaesthetic quality)
Proportion of Patients Who Need Supplementation of Opioids	Up to 2 hours after last epidural injection	Proportion of patients who need supplementation of the block intraoperatively with intravenous opioids
Proportion of Patients Who Need General Anaesthesia	Up to 2 hours after last epidural injection	Proportion of patients who need general anaesthesia
Discomfort and Pain During Surgery	Up to 2 hours after last epidural injection	Discomfort and pain assessed during surgery through spontaneous patient's reporting and questioning by the Investigator/anaesthesiologist
Maternal Treatment-emergent Adverse Events	Up to day 3±1 after surgery	Maternal treatment-emergent adverse events, with particular attention to pain (see above), pruritus, nausea, vomiting
Pulse Rate	Up to 12 hours after surgery	Maternal pulse rate
Total Dose of Phenylephrine	Up to 2 hours after last epidural injection	Total dose (μg) of phenylephrine
Time From T0 to Loss Light Touch Sensation	Up to 1 hour after last epidural injection	Time from T0 to loss light touch sensation to the metameric level T5 (block to T5), bilateral
Motor Block Assessment	Up to 12 hours after surgery	Motor block assessment (modified Bromage scale) at baseline, prior to incision and after surgery
First Breakthrough Pain	Up to 12 hours after surgery	First breakthrough pain assessed by the patient, recorded on a 0-10 cm VAS (0=no pain, 10= most severe pain imaginable)
Neonate Apgar	1 and 5 minutes after birth	Neonate Apgar scores at 1 and 5 minutes
Foetal Hypoxic Stress	Up to 12 hours after surgery	Indication of foetal hypoxic stress
Pain at the Site of Surgery	Up to 12 hours after surgery	Pain at the site of surgery at final visit/early termination visit, recorded on a 0-10 cm VAS (0=no pain, 10=most severe pain imaginable)
Pain at the Site of Epidural Injection	Up to 12 hours after surgery	Pain at the site of epidural injection at final visit/early termination visit, recorded on a 0-10 cm VAS (0=no pain, 10=severe pain)