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

Condition(s) targeted: Stillborn Caesarean Section

Intervention: Bupivacaine- Fentanyl - Normal Saline (Drug); Ropivacaine-Fentanyl-Normal Saline (Drug); Levobupivacaine- Fentanyl- Normal Saline (Drug); Bupivacaine + Fentanyl (Drug); Ropivacaine + Fentanyl (Drug); Levobupivacaine + Fentanyl (Drug)

Phase: Phase 2/Phase 3

Status: Recruiting

Sponsored by: University of Patras

Official(s) and/or principal investigator(s):
KRITON S FILOS, PROFESSOR, Study Chair, Affiliation: Department of Anesthesiology and Intensive Care Medicine, University Hospital of Patras
Christina G Sklavou, MD, Principal Investigator, Affiliation: Department of Anesthesia and Intensive Care Medicine, University Hospital of Patras

Overall contact:
KRITON S FILOS, PROFESSOR, Phone: +302613603341, Ext: +30, Email: kritonfilos@yahoo.gr

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.

Official title: Assessment of Sensory and Motor Block After Intrathecal Administration of Bupivacaine, Ropivacaine and Levo-bupivacaine Combined With Small Doses of Fentanyl, Followed by Administration of Normal Saline Epidurally:a Clinical Trial in Parturients Scheduled for C-section

Study design: Allocation: Randomized, Endpoint Classification: Safety/Efficacy Study, Intervention Model: Parallel Assignment, Masking: Double Blind (Subject, Investigator, Outcomes Assessor), Primary Purpose: Supportive Care

Primary outcome:

Dermatomes of Sensory block

Motor block

Secondary outcome: Arterial Blood Pressure

Detailed 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.

Minimum age: 18 Years. Maximum age: 40 Years. Gender(s): Female.

Criteria:

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

KRITON S FILOS, PROFESSOR, Phone: +302613603341, Ext: +30, Email: kritonfilos@yahoo.gr

Department of Anesthesiology and Intensive Care Medicine, University Hospital of Patras, Patras, Achaia 26504, Greece; Recruiting
KRITON S FILOS, PROFESSOR, Phone: +302613603342, Ext: +30, Email: kritonfilos@yahoo.gr
Christina G Sklavou, MD, Phone: +306974337046, Ext: +30, Email: sklavou.christina@yahoo.gr
Christina G Sklavou, MD, Principal Investigator

Starting date: January 2010
Last updated: April 26, 2012