Clinical trial NCT02919072: Chloroprocaine 3% - Epidural Anesthesia in Unplanned Caesarean Section
Official title: Comparison of Epidural Chloroprocaine 3% and Ropivacaine 0.75% for Unplanned Caesarean Section in Labouring Women Who Have an Epidural Catheter in Situ
Study type: INTERVENTIONAL
Overall status: TERMINATED
Phase: PHASE3
Conditions: Unplanned Caesarean Section
Lead sponsor: Sintetica SA
Sponsor class: INDUSTRY
Collaborators: name: Cross Research S.A.
First posted: 2016-09-29
Enrollment: 16
Sex: FEMALE
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

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.

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.

Primary outcomes:
measure: Time to the Onset of Anaesthesia
timeFrame: Up to 1 hour after last epidural injection
Secondary outcomes:
measure: Time From T0 to Loss Light Touch Sensation
timeFrame: Up to 1 hour after last epidural injection
measure: Quality of the Block
timeFrame: Quality of the block assessed between 10 and 20 minutes after the end of surgery
measure: Maximum Metameric Level of the Sensory Block
timeFrame: Up to 1 hrs after last epidural injection
measure: Motor Block Assessment
timeFrame: Up to 12 hours after surgery
measure: Proportion of Patients Who Need Top-up Anaesthesia
timeFrame: Up to 2 hours after last epidural injection
measure: Proportion of Patients Who Need Supplementation of Opioids
timeFrame: Up to 2 hours after last epidural injection
measure: Proportion of Patients Who Need General Anaesthesia
timeFrame: Up to 2 hours after last epidural injection
measure: Discomfort and Pain During Surgery
timeFrame: Up to 2 hours after last epidural injection
measure: First Breakthrough Pain
timeFrame: Up to 12 hours after surgery
measure: Maternal Treatment-emergent Adverse Events
timeFrame: Up to day 3±1 after surgery
measure: Pulse Rate
timeFrame: Up to 12 hours after surgery
measure: Oximetry
timeFrame: Up to 12 hours after surgery
measure: Electrocardiogram
timeFrame: Up to 12 hours after surgery
measure: Total Dose of Phenylephrine
timeFrame: Up to 2 hours after last epidural injection
measure: Total Dose of Atropine
timeFrame: Up to 2 hours after last epidural injection
measure: Intravenous Fluids
timeFrame: Up to 12 hours after surgery
measure: Neonate Apgar
timeFrame: 1 and 5 minutes after birth
measure: Foetal Hypoxic Stress
timeFrame: Up to 12 hours after surgery
measure: Pain at the Site of Surgery
timeFrame: Up to 12 hours after surgery
measure: Pain at the Site of Epidural Injection
timeFrame: Up to 12 hours after surgery
measure: Concomitant Medications
timeFrame: Up to day 3±1 after surgery
measure: Neonatal Adverse Events
timeFrame: Up to day 3±1 after surgery
Other outcomes:
Locations:
city: Leuven
country: Belgium
facility: UZ Leuven, campus Gasthuisberg
Study officials:
affiliation: Department of Anesthesiology, UZ Leuven, campus Gasthuisberg
name: Marc Van de Velde, MD
role: PRINCIPAL_INVESTIGATOR
References: