pregnant women, in labour requiring emergency caesarean section under epidural anaesthesia
Conditions
Interventions
Trade Name: levobupivacaine 0.5% (chirocaine)
Product Name: LEVOBUPIVACAINE 0.5%
Pharmaceutical Form: Injection*
Trade Name: lidocaine 2%
Sponsors
Hull & East Yorkhire NHS Hospitals Trust
Eligibility
Sex/Gender
All
Inclusion criteria
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
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
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Main Objective: TO COMPARE LEVOBUPIVACAINE 0.5% WITH LIDOCAINE 2%/FENTANYL/EPINEPHRINE FOR EPIDURAL TOP-UP FOR EMERGENCY CAESAREAN SECTION AFTER "LOW DOSE" EPIDURAL ANALGESIA FOR LABOUR. 1. TIME TAKEN FROM THE START OF EPIDURAL DRUG PREPARATION, UNTIL READINESS FOR SURGERY, IS FASTER WITH LEVOBUPIVACAINE THAN LIDOCAINE/EPINEPHRINE/FENTANYL MIXTURE ; Secondary Objective: 1. SPEED OF ONSET OF ANAESTHESIA AND ANALGESIA BETWEEN THE TWO MIXTURES 2.MATERNAL SATISFACTION 3. DEGREE OF HYPOTENSION WITH BOTH DRUG MIXTURES 4. DEGREE AND DURATION OF MOTOR BLOCK 5. INCIDENCE OF NAUSEA, VOMITING AND ITCHING ;Primary end point(s): WE HAVE DECIDED TO DO THE STUDY IN 100 PAITENTS ( 50 IN EACH GROUP). WE NORMALLY DO NEARLY 300 EMERGENCY CS AFTER LABOUR EPIDURAL UNDER EPIDURAL TOP-UP. SO WE MAY BE ABLE TO FINISH THE STUDY IN 6-8 MONTHS. PRIMARY END POINT WILL BE THE SAME AS NORMAL CLINICAL CARE FOR ALL PREGNANT WOMEN HAVING CAESAREAN SECTION. WE WILL FOLLOW NORMALLY 36-48 HOURS AFTER DELIVERY TO CLOSELY WATCH FOR DRUG EFFECTS AND ALSO EFFECT OF EPIDURAL ON EVERY PATIENTS. | — |
Countries
United Kingdom
Outcome results
None listed