Extending low-dose epidural for emergency Caesarean section - a comparison of bicarbonated lidocaine with 0.5% levobupivacaine

Status

Not yet recruiting

Phases

Unknown

Study type

Interventional

Source

EU CTR

Registry ID

EUCTR2006-001033-18-GB

Enrollment

100

Registered

2006-04-10

Start date

2006-05-22

Completion date

Unknown

Last updated

2012-03-19

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

None listed

Interventions

Trade Name: sodium bicarbonate Product Name: sodium bicarbonate Product Code: Pa 255/1/4 Pharmaceutical Form: Injection* Concentration unit: % percent Concentration type: equal Concentration number: 8

Eligibility

Sex/Gender

All

Inclusion criteria

Inclusion criteria: Inclusion criteria will be established labour beyond 36 weeks gestation and women requesting an epidural for pain relief in labour. 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) no F.1.3.1 Number of subjects for this age range

Exclusion criteria

Exclusion criteria: Exclusion critera will be an epidural top-up of solution stronger than bupivacaine 0.1% within the previous hour, pehtidine in the last 4 hours, multiple preganct, pre-eclampsia, antepartum haemmorage, cardiac disease, any contra-indication to regional analgesia or anaesthesia and any allergy to non-steroidal anti-inflammatory drugs

Design outcomes

Primary

Measure	Time frame
Main Objective: To establish whether the use of bicarbonated lidocaine when extending low-dose epidural analgesia in labour for emergency Caesarean section has a faster onset than 0.5% levobupivacaine;Secondary Objective: 1) Is there an improvement in the quality of epidural blockade achieved? 2) Is there a reduction in side effects? eg.low blood pressure, high blocks ;Primary end point(s): Time of achieving appropriate anaesthetic sensory block for Caesarean section	—

Measure

Time frame

Main Objective: To establish whether the use of bicarbonated lidocaine when extending low-dose epidural analgesia in labour for emergency Caesarean section has a faster onset than 0.5% levobupivacaine;Secondary Objective: 1) Is there an improvement in the quality of epidural blockade achieved? 2) Is there a reduction in side effects? eg.low blood pressure, high blocks ;Primary end point(s): Time of achieving appropriate anaesthetic sensory block for Caesarean section

—

Countries

United Kingdom

Outcome results