E.1 Medical condition or disease under investigation |
E.1.1 | Medical condition(s) being investigated |
Local epidural anaesthesia in labouring women who have an epidural
catheter in situ and established analgesia and need unplanned
Caesarean |
|
E.1.1.1 | Medical condition in easily understood language |
Local epidural anaesthesia in labouring women who have an epidural
catheter in situ and established analgesia and need unplanned
Caesarean |
|
E.1.1.2 | Therapeutic area | Analytical, Diagnostic and Therapeutic Techniques and Equipment [E] - Anesthesia and Analgesia [E03] |
MedDRA Classification |
E.1.2 Medical condition or disease under investigation |
E.1.2 | Version | 20.0 |
E.1.2 | Level | PT |
E.1.2 | Classification code | 10024758 |
E.1.2 | Term | Local anaesthesia |
E.1.2 | System Organ Class | 10042613 - Surgical and medical procedures |
|
E.1.3 | Condition being studied is a rare disease | No |
E.2 Objective of the trial |
E.2.1 | Main objective of the trial |
The objective of this study is to test the superiority in terms of the onset
time of anaesthesia and to 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. |
|
E.2.2 | Secondary objectives of the trial |
|
E.2.3 | Trial contains a sub-study | No |
E.3 | Principal 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 (4)
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 cooperate
with the investigator and to comply with the requirements of the entire study. |
|
E.4 | Principal 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. |
|
E.5 End points |
E.5.1 | Primary end point(s) |
The primary study end-point is the time to the onset of anaesthesia (i.e.
the time to reach adequate surgical conditions) |
|
E.5.1.1 | Timepoint(s) of evaluation of this end point |
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. |
|
E.5.2 | Secondary end point(s) |
The secondary end-points are:
- Time from T0 to loss of pinprick and light touch sensation to the
metameric level T5 (block to T5), bilateral
- 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)
- Maximum metameric level of the sensory block assessed by three
modalities (complete loss of cold, pinprick and light touch sensation)
- Motor block assessment (modified Bromage scale) at baseline, prior to
incision and after surgery
- Proportion of patients who need top-up epidural anaesthesia (same
anaesthetic as first epidural injection)
- Proportion of patients who need supplementation of the block
intraoperatively with intravenous opioids or general anaesthesia
- Proportion of patients who need general anaesthesia
Safety end-points are:
- Discomfort and pain assessed during surgery through spontaneous patient's reporting and questioning by the Investigator/anaesthesiologist
- First breakthrough pain assessed by the patient, recorded on a 0-10 cm
VAS (0=no pain, 10= most severe pain imaginable)
- Maternal treatment-emergent adverse events, with particular attention
to pain (see above), pruritus, nausea, vomiting
- Maternal vital signs, pulse rate, pulse oximetry (SpO2) and
electrocardiogram, monitored from baseline to end of surgery according
to the hospital standard procedures
- Total dose of phenylephrine and total dose of atropine
- Total volume of intravenous fluids
- Neonate Apgar scores at 1 and 5 minutes
- Umbilical artery and venous blood gases (partial pressure of carbon
dioxide [pCO2], partial pressure of oxygen [pO2], acidity [pH], base
excess [BE]) as an indication of foetal hypoxic stress
- 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 at final visit/early termination
visit, recorded on a 0-10 cm VAS (0=no pain, 10=severe pain)
- Concomitant medications
- Neonatal adverse events |
|
E.5.2.1 | Timepoint(s) of evaluation of this end point |
-Time from T0 to loss of pinprick and light touch sensation to the
metameric level T5 (block to T5), bilateral
- Quality of the block assessed between 10 and 20 min after the end of
surgery
- Sensory block will be assessed after injection(s), during and after
surgery
- Motor block assessment at baseline, prior to incision and after surgery
- Before, during and after surgery, all adverse events will be recorded |
|
E.6 and E.7 Scope of the trial |
E.6 | Scope of the trial |
E.6.1 | Diagnosis | No |
E.6.2 | Prophylaxis | No |
E.6.3 | Therapy | No |
E.6.4 | Safety | Yes |
E.6.5 | Efficacy | Yes |
E.6.6 | Pharmacokinetic | No |
E.6.7 | Pharmacodynamic | No |
E.6.8 | Bioequivalence | No |
E.6.9 | Dose response | No |
E.6.10 | Pharmacogenetic | No |
E.6.11 | Pharmacogenomic | No |
E.6.12 | Pharmacoeconomic | No |
E.6.13 | Others | No |
E.7 | Trial type and phase |
E.7.1 | Human pharmacology (Phase I) | No |
E.7.1.1 | First administration to humans | No |
E.7.1.2 | Bioequivalence study | No |
E.7.1.3 | Other | No |
E.7.1.3.1 | Other trial type description | |
E.7.2 | Therapeutic exploratory (Phase II) | No |
E.7.3 | Therapeutic confirmatory (Phase III) | Yes |
E.7.4 | Therapeutic use (Phase IV) | No |
E.8 Design of the trial |
E.8.1 | Controlled | Yes |
E.8.1.1 | Randomised | Yes |
E.8.1.2 | Open | No |
E.8.1.3 | Single blind | No |
E.8.1.4 | Double blind | Yes |
E.8.1.5 | Parallel group | No |
E.8.1.6 | Cross over | No |
E.8.1.7 | Other | No |
E.8.2 | Comparator of controlled trial |
E.8.2.1 | Other medicinal product(s) | Yes |
E.8.2.2 | Placebo | No |
E.8.2.3 | Other | Yes |
E.8.2.3.1 | Comparator description |
|
E.8.2.4 | Number of treatment arms in the trial | 2 |
E.8.3 |
The trial involves single site in the Member State concerned
| Yes |
E.8.4 | The trial involves multiple sites in the Member State concerned | No |
E.8.5 | The trial involves multiple Member States | Yes |
E.8.5.1 | Number of sites anticipated in the EEA | 4 |
E.8.6 Trial involving sites outside the EEA |
E.8.6.1 | Trial being conducted both within and outside the EEA | No |
E.8.6.2 | Trial being conducted completely outside of the EEA | No |
E.8.7 | Trial has a data monitoring committee | No |
E.8.8 |
Definition of the end of the trial and justification where it is not the last
visit of the last subject undergoing the trial
|
The study will be considered terminated at the date of the last visit of
the last subject or upon completion of any follow-up procedure
described in protocol. |
|
E.8.9 Initial estimate of the duration of the trial |
E.8.9.1 | In the Member State concerned years | 1 |
E.8.9.1 | In the Member State concerned months | 2 |
E.8.9.1 | In the Member State concerned days | |