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A randomised comparison of 0.5% levobupivacaine with a lidocaine/epinephrine/ fentanyl mixture for epidural top up for emergency caesarean section after low dose” epidural for labour - levobup v LEF for epidural top up

Phase 1
Conditions
pregnant women, in labour requiring emergency caesarean section under epidural anaesthesia
Registration Number
EUCTR2006-000333-36-GB
Lead Sponsor
Hull & East Yorkhire NHS Hospitals Trust
Brief Summary

Not available

Detailed Description

Not available

Recruitment & Eligibility

Status
ot Recruiting
Sex
Not specified
Target Recruitment
0
Inclusion Criteria

1. SUITABLE FOR LSCS UNDER EPIDURAL
2.MOTHER AND BABY SHOULD NOT BE IN ANY IMMEDIATE DANGER
3.SINGLETON PREGNANCY
4.MOTHER CONSENTED TO PARTICIPATE IN TRIAL
5. NO CONTRAINDICATION FOR REGIONAL ANAESTHESIA
6. ABOVE 16 YEARS OF AGE
7. ASA GRADE I AND GRADE II
Are the trial subjects under 18? no
Number of subjects for this age range:
F.1.2 Adults (18-64 years) yes
F.1.2.1 Number of subjects for this age range
F.1.3 Elderly (>=65 years)
F.1.3.1 Number of subjects for this age range

Exclusion Criteria

1. UNDER 16 YEARS OF AGE
2.FAILED BLOCK OR POORLY FUNCTIONING EPIDURAL IN THIS LABOUR
3.ANTEPARTUM HAEMORRHAGE,ABRUPTION,PROLAPSED CORD, SEVERE FETAL DISTRESS
4.MULTIPLE PREGNANCY
5. SIGNIFICANT HYPOTENSION WITH PREVIOUS TOP-UPS DURING THIS LABOUR
6. HYPERTENSION COMPICATING PREGNANCY NEEDING DRUG THERAPY
7. FETAL ABNORMALITY
8. MULTIPLE PREGNANCIES

Study & Design

Study Type
Interventional clinical trial of medicinal product
Study Design
Not specified
Primary Outcome Measures
NameTimeMethod
Secondary Outcome Measures
NameTimeMethod
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