E.1 Medical condition or disease under investigation |
E.1.1 | Medical condition(s) being investigated |
Conversion of labour epidural to surgical anaesthesia for emergency Caesarean section |
|
MedDRA Classification |
E.1.2 Medical condition or disease under investigation |
E.1.2 | Version | 12.1 |
E.1.2 | Level | LLT |
E.1.2 | Classification code | 10006924 |
E.1.2 | Term | Caesarean section |
|
E.1.2 Medical condition or disease under investigation |
E.1.2 | Version | 12.1 |
E.1.2 | Level | LLT |
E.1.2 | Classification code | 10054375 |
E.1.2 | Term | Epidural anesthesia |
|
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 |
Which one of the local anaesthetics, ropivacaine or levobupivacaine, provides the best option for converting an epidural that has been used for labour into one that is suitable for and emergency Caesarean section. Defined as which one has the least episodes of 'breakthrough' pain during the operation and needs supplementing with further drugs least often. |
|
E.2.2 | Secondary objectives of the trial |
Main = time elapsed between administration of the top-up and onset of anaesthesia suitable for surgery to proceed (defined as a loss of sensation to cold to T4 dermatomal level)
Other secondary endpoints: • Requirement for preoperative supplementation • Incidence of breakthrough pain and its intensity • Number of patients requiring conversion to spinal or general anaesthetic should the epidural technique fail. • Incidence of side effects: • Nausea • Vomiting • Shivering • Itching • Use and dose of vasopressor phenylephrine (50mcg bolus) and Hartmann’s solution (200ml bolus) • Overall patient satisfaction score • Motor block at end of EmCS (Bromage Scale) • Neonatal Apgar scores • Umbilical cord blood gases taken after delivery
|
|
E.2.3 | Trial contains a sub-study | No |
E.3 | Principal inclusion criteria |
Any subject requiring a grade 2 or 3 EmCS on the Hospital Birth Centre, St Thomas’ who has: 1.Labour analgesia provided by the standard patient controlled epidural (solution containing 0.1% levobupivacaine and 2mcg/ml fentanyl). That is providing analgesia via the patient controlled epidural analgesia infusion pump without the need for multiple extra boluses of epidural local anaesthetic and or opiates from the anaesthetist on the labour ward.. 2.Singleton pregnancy. 3.Established labour, determined by the midwife responsible for the patient (usually by vaginal examination of the cervix). 4.Gestation >36 weeks 5.No complex past medical history according to the judgement of the investigator 6.> 18 years of age 7.EmCS starts between the hours 0800 and 1800. 8.Had a minimum total dose of 50mcg of fentanyl via the epidural since its insertion. 9.The ability to understand the patient information sheet and willing to provide informed consent.
|
|
E.4 | Principal exclusion criteria |
Any of the following conditions or situations would preclude involvement in the trial: 1.Pre-eclampsia / Eclampsia 2.Antepartum haemorrhage 3.Any congenital, valvular or ischaemic heart disease. 4.Category 1 EmCS. 5.Participation in another therapeutic study in the last 12 weeks. |
|
E.5 End points |
E.5.1 | Primary end point(s) |
The primary endpoint will be intra-operative supplementation rate. This is defined as how often the epidural top-ups require further drugs to control pain during the EmCS in each arm of the trial.
|
|
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 | No |
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) | No |
E.7.4 | Therapeutic use (Phase IV) | Yes |
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 | Yes |
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 | No |
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 | No |
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 | Information not present in EudraCT |
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 end of the trial will be when the last patient completes the trial i.e. when the last patient leaves the operating theatre after their Caesarean section. |
|
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 | |
E.8.9.1 | In the Member State concerned days | |
E.8.9.2 | In all countries concerned by the trial years | 1 |