Epidural Volume Extension and Intrathecal Use of Local Anesthetics in Cesarean Sections

University of Patras

Status and phase: Unknown; Phase 3; Phase 2

Conditions: Stillborn Caesarean Section

Treatments: Drug: Ropivacaine + Fentanyl; Drug: Ropivacaine-Fentanyl-Normal Saline; Drug: Bupivacaine + Fentanyl; Drug: Bupivacaine- Fentanyl - Normal Saline; Drug: Levobupivacaine + Fentanyl; Drug: Levobupivacaine- Fentanyl- Normal Saline

Study type: Interventional

Funder types: Other

Identifiers

NCT01558713

1312010-25

Details and patient eligibility

About

Intrathecal (i.t.) administration of isobaric bupivacaine, ropivacaine and levobupivacaine with addition of fentanyl for c-section either combined or not with administration of 10 ml of N/S 0,9% epidurally, in order to extent epidural space.Sensory and motor block profile, haemodynamics and side effects were assessed.

Full description

Parturients scheduled for elective caesarean section are randomly allocated to 6 groups: they receive double-blindly intrathecal isobaric bupivacaine 10 mg ( Group B), ropivacaine 15mg (Group R) , levobupivacaine 10mg (Group L) combined with 10 μg fentanyl and followed by epidural administration of 10 ml of N/S 0,9% respectively, and isobaric bupivacaine 10 mg ( Group BupivacaineF), ropivacaine 15mg (Group RopivacaineF) , and levobupivacaine 10mg (Group LevobupivacaineF) combined with 10 μg fentanyl without epidural administration of 10 ml of N/S 0,9%. Clinical endpoints are the sensory and motor block profile, haemodynamics (arterial pressure, heart rate) and side effects.

Enrollment: 120 estimated patients

Sex: Female

Ages: 18 to 40 years old

Volunteers: Accepts Healthy Volunteers

Inclusion criteria

• Elective cesarean section
• ASA I-II

Exclusion criteria

• complicated pregnancy (i.e preeclampsia, eclampsia,arterial hypertension, diabetes mellitus)
• abnormal fetal heart rate at the time of admission
• body mass index > 35 kg/m2
• height <150cm and >185 cm
• age <18 yrs and >40 yrs
• patients with contraindication to spinal anaesthesia( i.e anticoagulants)
• ASA >III
• intraoperative excessive bleeding
• patients with previous psychiatric diseases

Trial design

Primary purpose: Supportive Care

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: Triple Blind

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120 participants in 6 patient groups

Group BFS

Active Comparator group

Description:

Group B: BUPIVACAINE 0,5% 2ml + 10μg FENTANYL(0,2ml) INTRATHECALLY, FOLLOWED BY EPIDURAL ADMINISTRATION OF 10 ml N/S 0,9%

Treatment:

Drug: Bupivacaine- Fentanyl - Normal Saline

Group RFS

Active Comparator group

Description:

Group R : ROPIVACAINE 0,75% 2ml + 10μg FENTANYL ( 0,2ml) INTRATHECALLY, FOLLOWED BY EPIDURAL ADMINISTRATION OF 10 ml N/S 0,9%

Treatment:

Drug: Ropivacaine-Fentanyl-Normal Saline

Group LFS

Active Comparator group

Description:

Group L: LEVO-BUPIVACAINE 0,5% 2ml + 10μg FENTANYL(0,2ml) INTRATHECALLY, FOLLOWED BY EPIDURAL ADMINISTRATION OF 10 ml N/S 0,9%

Treatment:

Drug: Levobupivacaine- Fentanyl- Normal Saline

BupivacaineF

Active Comparator group

Description:

Group BupivacaineF: BUPIVACAINE 0,5% 2ml + 10μg FENTANYL(0,2ml) INTRATHECALLY

Treatment:

Drug: Bupivacaine + Fentanyl

RopivacaineF

Active Comparator group

Description:

Group RopivacaineF : ROPIVACAINE 0,75% 2ml + 10μg FENTANYL ( 0,2ml) INTRATHECALLY.

Treatment:

Drug: Ropivacaine + Fentanyl

LevobupivacaineF

Active Comparator group

Description:

Group LevobupivacaineF: LEVO-BUPIVACAINE 0,5% (2ml) + 10μg FENTANYL(0,2ml) INTRATHECALLY.

Treatment:

Drug: Levobupivacaine + Fentanyl