Condition category
Pregnancy and Childbirth
Date applied
Date assigned
Last edited
Retrospectively registered
Overall trial status
Recruitment status
No longer recruiting
Publication status

Plain English Summary

Not provided at time of registration

Trial website

Contact information



Primary contact

Dr P Balaji


Contact details

Hull Royal Infirmary
Anlaby Road
United Kingdom

Additional identifiers

EudraCT number number

Protocol/serial number


Study information

Scientific title


Study hypothesis

In our Trust, we commonly give lidocaine/epinephrine/fentanyl mixture for epidural top up for all pregnant women having emergency caesarian section. It takes a few minutes to mix this drug mixture however, 0.5% Levobupicaine is being used in a few other Trusts because of less time needed to give the solution, less side effects and longer duration of action. As no study has compared these two solutions, we have decided to compare both the solutions and to see whether 0.5% Levobupivacaine is superior to Lidocaine/Epinephrine/Fentanyl mixture for this group of patients. The principal research question is whether the time taken from the start of epidural drug preparation, until readiness for the surgery, is faster with Levobupivacaine or with Lidocaine/Fentanyl/Epinephrine mixture.

Ethics approval

Not provided at time of registration

Study design

Prospective randomised single blind study

Primary study design


Secondary study design

Randomised controlled trial

Trial setting


Trial type


Patient information sheet

Not available in web format, please use the contact details below to request a patient information sheet


Pregnancy and Childbirth: Caesarean section


This study is a prospective randomised single blind study that compares two commonly used epidural top up mixtures. This study will be done in women's and children's hospital, HRI. During one year period there would usually be at least 300 epidural top ups for emergency LSCS in our labour suite. We decided to have a sample size of 50 patients in each group and calculated the power analysis from previous studies with alpha and beta of 0.05 and 0.2 respectively, looking for a 20% difference in the supplementation (either extra supplement of study drug or conversion to general anaesthetics) as highly significant. All patients having an epidural sited for pain relief in labour, once pain free, will be approached, and be asked to give informed consent. Using sealed envelopes, computer generated numbers will direct the anaesthetists as to which solution to use should an emergency LSCS become necessary. Usual documentation will be supplemented with the study data sheet and the anaesthetists responsible for the case will be asked to record all the relevant data. These sheets will be marked with the patients unit number and trial number so that follow up is possible. The data will be stored on a computerised database according to trial number alone. for any individual patient the study will end on completion of the study questionnaire during the routine anaesthetic follow up at 24 - 28 hours post LSCS. Consent will be obtained from women who are pain free after having received an epidural for pain relief during labour. Should such a patient require an emergency LSCS, the anaesthetist will time themselves preparing the randomly allocated solution. A stop watch situated in a trolley will allow for accurate time measurements and cause of any delays eg locating keys/ODA etc will be noted. details of the woman's previous top ups will be recorded, as well as the anaesthetic/analgesic levels and the degree of motor block immediately prior to top up for LSCS.

Intervention type



Not Specified

Drug names

Levobupivacaine, lidocaine/epinephrine/fentanyl

Primary outcome measure

The time from start of top up drug preparation until the patient is ready for surgery (block to T6).

Secondary outcome measures

Not provided at time of registration

Overall trial start date


Overall trial end date


Reason abandoned (if study stopped)


Participant inclusion criteria

1. Participants suitable for LSCS under epidural
2. Mother and baby not in any immediate danger
3. Singleton pregnancy
4. > 16 years of age
5. No contraindication for regional anaesthesia
6. ASA grade I and grade II

Participant type


Age group




Target number of participants


Participant exclusion criteria

1. A failed block in this labour
2. Poorly functioning epidural in this labour
3. Significant hypertension with previous top-ups during this labour
4. Under 16 years of age
5. Ante partum haemorrhage/abruption
6. Prelapsed cord
7. Severe fetal distress
8. Multiple pregnancies
9. Hypertension complicating pregnancy requiring therapy

Recruitment start date


Recruitment end date



Countries of recruitment

United Kingdom

Trial participating centre

Hull Royal Infirmary
United Kingdom

Sponsor information


Record Provided by the NHSTCT Register - 2007 Update - Department of Health

Sponsor details

The Department of Health
Richmond House
79 Whitehall
United Kingdom
+44 (0)20 7307 2622

Sponsor type




Funder type


Funder name

The North and South Bank Research and Development Consortium (UK), NHS R&D Support Funding

Alternative name(s)

Funding Body Type

Funding Body Subtype


Results and Publications

Publication and dissemination plan

Not provided at time of registration

Intention to publish date

Participant level data

Not provided at time of registration

Basic results (scientific)

Publication list

1. 2006 results in

Publication citations

  1. Results

    Goring-Morris J, Russell IF, A randomised comparison of 0.5% bupivacaine with a lidocaine/epinephrine/fentanyl mixture for epidural top-up for emergency caesarean section after "low dose" epidural for labour., Int J Obstet Anesth, 2006, 15, 2, 109-114, doi: 10.1016/j.ijoa.2005.11.005.

Additional files

Editorial Notes