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

Authors
Category Primary study
Registry of TrialsISRCTN registry
Year 2007
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. CONDITION: Pregnancy and Childbirth: Caesarean section ; Pregnancy and Childbirth ; Caesarean section PRIMARY OUTCOME: The time from start of top up drug preparation until the patient is ready for surgery (block to T6). SECONDARY OUTCOME: Not provided at time of registration 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
Epistemonikos ID: 0cf2b71b23ed8ed2e47c8777b4bb7cb9b2cb4e20
First added on: Aug 21, 2024