A randomised comparison between 0.5% Levobupivacaine with a lidocaine/epinephrine/fentanyl mixture for epidural top up for emergency caesarean section after low dose epidural for labour
| ISRCTN | ISRCTN67840624 |
|---|---|
| DOI | https://doi.org/10.1186/ISRCTN67840624 |
| Secondary identifying numbers | N0084182454 |
- Submission date
- 28/09/2007
- Registration date
- 28/09/2007
- Last edited
- 25/04/2012
- Recruitment status
- No longer recruiting
- Overall study status
- Completed
- Condition category
- Pregnancy and Childbirth
Prospectively registered
Protocol
Statistical analysis plan
Results
Individual participant data
Plain English summary of protocol
Not provided at time of registration
Contact information
Dr P Balaji
Scientific
Scientific
Hull Royal Infirmary
Anlaby Road
Hull
HU3 2JZ
United Kingdom
Study information
| Study design | Prospective randomised single blind study |
|---|---|
| Primary study design | Interventional |
| Secondary study design | Randomised controlled trial |
| Study setting(s) | Hospital |
| Study type | Treatment |
| Participant information sheet | Not available in web format, please use the contact details below to request a patient information sheet |
| Scientific title | |
| Study objectives | 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(s) | Not provided at time of registration |
| Health condition(s) or problem(s) studied | 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 |
| Pharmaceutical study type(s) | |
| Phase | Not Specified |
| Drug / device / biological / vaccine name(s) | 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 study start date | 13/04/2006 |
| Completion date | 22/01/2007 |
Eligibility
| Participant type(s) | Patient |
|---|---|
| Age group | Adult |
| Sex | Female |
| Target number of participants | 100 |
| Key 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 |
| Key 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 |
| Date of first enrolment | 13/04/2006 |
| Date of final enrolment | 22/01/2007 |
Locations
Countries of recruitment
- England
- United Kingdom
Study participating centre
Hull Royal Infirmary
Hull
HU3 2JZ
United Kingdom
HU3 2JZ
United Kingdom
Sponsor information
Record Provided by the NHSTCT Register - 2007 Update - Department of Health
Government
Government
The Department of Health, Richmond House, 79 Whitehall
London
SW1A 2NL
United Kingdom
| Phone | +44 (0)20 7307 2622 |
|---|---|
| dhmail@doh.gsi.org.uk | |
| Website | http://www.dh.gov.uk/Home/fs/en |
Funders
Funder type
Government
The North and South Bank Research and Development Consortium (UK), NHS R&D Support Funding
No information available
Results and Publications
| Intention to publish date | |
|---|---|
| Individual participant data (IPD) Intention to share | No |
| IPD sharing plan summary | Not provided at time of registration |
| Publication and dissemination plan | Not provided at time of registration |
| IPD sharing plan |
Study outputs
| Output type | Details | Date created | Date added | Peer reviewed? | Patient-facing? |
|---|---|---|---|---|---|
| Results article | results | 01/04/2006 | Yes | No |
