Condition category
Pregnancy and Childbirth
Date applied
28/09/2007
Date assigned
28/09/2007
Last edited
25/04/2012
Prospective/Retrospective
Retrospectively registered
Overall trial status
Completed
Recruitment status
No longer recruiting

Plain English Summary

Not provided at time of registration

Trial website

Contact information

Type

Scientific

Primary contact

Dr P Balaji

ORCID ID

Contact details

Hull Royal Infirmary
Anlaby Road
Hull
HU3 2JZ
United Kingdom

Additional identifiers

EudraCT number

ClinicalTrials.gov number

Protocol/serial number

N0084182454

Study information

Scientific title

Acronym

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

Interventional

Secondary study design

Randomised controlled trial

Trial setting

Hospitals

Trial type

Treatment

Patient information sheet

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

Condition

Pregnancy and Childbirth: Caesarean section

Intervention

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

Drug

Phase

Not Specified

Drug names

Levobupivacaine, lidocaine/epinephrine/fentanyl

Primary outcome measures

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

13/04/2006

Overall trial end date

22/01/2007

Reason abandoned

Eligibility

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

Patient

Age group

Adult

Gender

Female

Target number of participants

100

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

13/04/2006

Recruitment end date

22/01/2007

Locations

Countries of recruitment

United Kingdom

Trial participating centre

Hull Royal Infirmary
Hull
HU3 2JZ
United Kingdom

Sponsor information

Organisation

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

Sponsor details

The Department of Health
Richmond House
79 Whitehall
London
SW1A 2NL
United Kingdom
+44 (0)20 7307 2622
dhmail@doh.gsi.org.uk

Sponsor type

Government

Website

http://www.dh.gov.uk/Home/fs/en

Funders

Funder type

Government

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

Location

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

Results - basic reporting

Publication summary

1. 2006 results in http://www.ncbi.nlm.nih.gov/pubmed/16488138

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