Subarachnoid Administration of Levobupivacaine for Cesarean Section

University of Patras

Status and phase: Unknown; Phase 3; Phase 2

Conditions: Stillborn Caesarean Section

Treatments: Drug: ropivacaine plain +. fentanyl; Drug: Bupivacaine plain; Drug: Ropivacaine plain; Drug: bupivacaine plain +fentanyl; Drug: Levobupivacaine plain; Drug: Levobupivacaine plain +fentanyl

Study type: Interventional

Funder types: Other

Identifiers

NCT01582607

3089

Details and patient eligibility

About

The purpose of the investigators study is to compare the clinical effects and side-effects of these three local anaesthetics as sole agents or with the supplementation with fentanyl for c-section, especially when administered in doses achieving approximately an ED 50.

Full description

Intrathecal (i.t.) administration of isobaric bupivacaine, ropivacaine and levobupivacaine with or without addition of fentanyl for c-section do not exist to date .

Parturients scheduled for elective caesarean section will be allocated to receive double-blindly i.t. isobaric bupivacaine 10 mg, ropivacaine 15mg , levobupivacaine 10mg or the same local anaesthetics with 10 μg fentanyl respectively. Sensory block (pin prick test) and motor block (Bromage scale) profile, intraoperative and postoperative analgesia, haemodynamics and side effects will be assessed.

Enrollment: 130 estimated patients

Sex: Female

Ages: 18 to 40 years old

Volunteers: Accepts Healthy Volunteers

Inclusion criteria

• Parturients scheduled for elective c section
• Stillborn
• Normal cardiotocogram

Exclusion criteria

• BMI>35kg/m2
• Height <150cm or >185cm
• Age (<18, >40)
• ASA > II
• Multiple gestation
• Pregnancy complications (eclampsia, GDP, placenta previa, >2 previous c section)
• Contraindication to spinal anaesthesia
• Failure to educate the patient, language barrier
• Patient preferred GA

Trial design

Primary purpose: Supportive Care

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: Double Blind

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130 participants in 6 patient groups

Group B

Active Comparator group

Description:

subarachnoid administration of 2.0 mL (10mg) plain bupivacaine hydrochloride 0.5%

Treatment:

Drug: Bupivacaine plain

Group R

Active Comparator group

Description:

subarachnoid administration of 2.0 ml (15mg) plain ropivacaine 0.75%

Treatment:

Drug: Ropivacaine plain

Group LB

Active Comparator group

Description:

subarachnoid administration of 2.0 ml (10mg) plain levo-bupivacaine hydrochloride 0.5%

Treatment:

Drug: Levobupivacaine plain

Group RF

Active Comparator group

Description:

subarachnoid administration of 2.0 ml (15mg) plain ropivacaine 0.75% with 0.2 ml (10 μg) fentanyl

Treatment:

Drug: ropivacaine plain +. fentanyl

Group BF

Active Comparator group

Description:

subarachnoid administration of 2.0 ml (10mg) plain bupivacaine 0.5% with 0.2 ml (10 μg) fentanyl

Treatment:

Drug: bupivacaine plain +fentanyl

Group LBF

Active Comparator group

Description:

subarachnoid administration of 2.0 ml (10mg) plain levo-bupivacaine 0.5% with 0.2 ml (10 μg) fentanyl

Treatment:

Drug: Levobupivacaine plain +fentanyl