Subarachnoid Administration of Levobupivacaine for Cesarean Section

Intrathecal Plain Bupivacaine, Ropivacaine and Levo-bupivacaine With or Without Fentanyl for Elective c Section.

Status

UNKNOWN

Phases

Phase 2Phase 3

Study type

Interventional

Source

ClinicalTrials.gov

Registry ID

NCT01582607

Enrollment

130

Registered

2012-04-20

Start date

2010-01-31

Completion date

2012-05-31

Last updated

2012-04-20

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

Conditions

Stillborn Caesarean Section

Brief summary

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.

Detailed 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.

Interventions

DRUGBupivacaine plain

2.0 mL (10mg) plain bupivacaine hydrochloride 0.5% intrathecally

DRUGRopivacaine plain

2.0 ml (15mg) plain ropivacaine 0.75% intrathecally

DRUGLevobupivacaine plain

2.0 ml (10mg) plain levo-bupivacaine hydrochloride 0.5% intrathecally

DRUGbupivacaine plain +fentanyl

2.0 ml (10mg) plain bupivacaine 0.5% with 0.2 ml (10 μg) fentanyl intrathecally

DRUGropivacaine plain +. fentanyl

2.0 ml (15mg) plain ropivacaine 0.75% with 0.2 ml (10 μg) fentanyl intrathecally

DRUGLevobupivacaine plain +fentanyl

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

Study design

Allocation

RANDOMIZED

Intervention model

PARALLEL

Primary purpose

SUPPORTIVE_CARE

Masking

DOUBLE (Investigator, Outcomes Assessor)

Eligibility

Sex/Gender

FEMALE

Age

18 Years to 40 Years

Healthy volunteers

Yes

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

Design outcomes

Primary

Measure	Time frame	Description
Sensory block	up to 150 minutes average	sensory block (pin prick test): every 1 min until 30min, every 5 min until 60min. every 10 min until regression to O1 (average 150 minutes)
Motor block	up to 150 minutes	Motor block (Bromage scale): every 1 min until 30min, every 5 min until 60min. every 10 min until complete recovery of motor function (average 150 minutes)

Secondary

Measure	Time frame	Description
Hemodynamics profile (arterial pressure. heart rate)	up to 150 minutes average	Measurement of arterial pressure and heart rate every 1 min for the first 30 min, every 5 min until 60 min, every 10 min until regression of sensory or motor block(average 150 minutes)

Countries

Greece

Contacts

Primary ContactKriton S Filos, Professor

kritonfilos@yahoo.gr2610999341

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Feb 4, 2026