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
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
-
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.