Subarachnoid Administration of Levobupivacaine for Cesarean Section

Stillborn Caesarean Section Clinical Trial

Official title:

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

Clinical Trial Details — Status: Recruiting

Administrative data

• NCT number: NCT01582607
• Other study ID #: 3089
• Status: Recruiting
• Phase: Phase 2/Phase 3
• First received: April 14, 2012
• Last updated: April 19, 2012
• Start date: January 2010
• Est. completion date: May 2012

Study information

• Verified date: April 2012
• Source: University of Patras
• Contact: Kriton S Filos, Professor
• Phone: 2610999341
• Email: kritonfilos[@]yahoo.gr
• Is FDA regulated: No
• Health authority: Greece: Ministry of Health and Welfare
• Study type: Interventional

Clinical Trial 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.

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.

Recruitment information / eligibility

• Status: Recruiting
• Enrollment: 130
• Est. completion date: May 2012
• Est. primary completion date: April 2012
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: Female
• Age group: 18 Years to 40 Years

Eligibility

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

Study Design

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

Related Conditions & MeSH terms

• Stillborn Caesarean Section

Intervention

Drug:
• Bupivacaine plain
2.0 mL (10mg) plain bupivacaine hydrochloride 0.5% intrathecally
• Ropivacaine plain
2.0 ml (15mg) plain ropivacaine 0.75% intrathecally
• Levobupivacaine plain
2.0 ml (10mg) plain levo-bupivacaine hydrochloride 0.5% intrathecally
• bupivacaine plain +fentanyl
2.0 ml (10mg) plain bupivacaine 0.5% with 0.2 ml (10 µg) fentanyl intrathecally
• ropivacaine plain +. fentanyl
2.0 ml (15mg) plain ropivacaine 0.75% with 0.2 ml (10 µg) fentanyl intrathecally
• Levobupivacaine plain +fentanyl
2.0 ml (10mg) plain levo-bupivacaine 0.5% with 0.2 ml (10 µg) fentanyl intrathecally

Locations

Country	Name	City	State
Greece	University Hospital of Patras, Department of Anesthesiology	Patras	Achaia

Sponsors (1)

Lead Sponsor	Collaborator
University of Patras

Country where clinical trial is conducted

Greece, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Sensory block	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)	up to 150 minutes average	Yes
Primary	Motor block	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)	up to 150 minutes	Yes
Secondary	Hemodynamics profile (arterial pressure. heart rate)	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)	up to 150 minutes average	Yes