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

Stillborn Caesarean Section Clinical Trial

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

Clinical Trial Details — Status: Recruiting

Administrative data

• NCT number: NCT01558713
• Other study ID #: 1312010-25
• Status: Recruiting
• Phase: Phase 2/Phase 3
• First received: March 14, 2012
• Last updated: April 26, 2012
• Start date: January 2010
• Est. completion date: December 2012

Study information

• Verified date: April 2012
• Source: University of Patras
• Contact: KRITON S FILOS, PROFESSOR
• Phone: +302613603341
• Email: kritonfilos[@]yahoo.gr
• Is FDA regulated: No
• Health authority: Greece: Ethics Committee
• Study type: Interventional

Clinical Trial Summary

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.

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.

Recruitment information / eligibility

• Status: Recruiting
• Enrollment: 120
• Est. completion date: December 2012
• Est. primary completion date: September 2012
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: Female
• Age group: 18 Years to 40 Years

Eligibility

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

Study Design

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

Related Conditions & MeSH terms

• Stillborn Caesarean Section

Intervention

Drug:
• Bupivacaine- Fentanyl - Normal Saline
Bupivacaine 0,5%, 2ml (10mg)bolus, Fentanyl 50µg/ml, 0,2ml (10 µg)bolus, Normal Saline 0,9%, 10ml bolus
• Ropivacaine-Fentanyl-Normal Saline
Ropivacaine 0,75%, 2ml (15mg)bolus, Fentanyl 50µg/ml, 0,2ml (10 µg)bolus, Normal Saline 0,9%, 10ml bolus
• Levobupivacaine- Fentanyl- Normal Saline
Levo-bupivacaine 0,5%, 2ml (10mg)bolus, Fentanyl 50µg/ml, 0,2ml (10 µg)bolus, Normal Saline 0,9%, 10ml bolus
• Bupivacaine + Fentanyl
Bupivacaine 0,5%, 2ml (10mg)bolus, Fentanyl 50µg/ml, 0,2ml (10 µg)bolus
• Ropivacaine + Fentanyl
Ropivacaine 0,75%, 2ml (15mg)bolus, Fentanyl 50µg/ml, 0,2ml (10 µg)bolus.
• Levobupivacaine + Fentanyl
Levo-bupivacaine 0,5%, 2ml (10mg)bolus, Fentanyl 50µg/ml, 0,2ml (10 µg)bolus

Locations

Country	Name	City	State
Greece	Department of Anesthesiology and Intensive Care Medicine, University Hospital of Patras	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	Dermatomes of Sensory block	Dermatomes of sensory block(pin prick test) are assessed every minute for the first 30 minutes after the intrathecal administration of local anesthetics and there after every 5 minutes until withdrawal of sensory block	up to 120 minutes average	Yes
Primary	Motor block	Motor block according to the Bromage scale are assessed every minute for the first 30 minutes after the intrathecal administration of local anesthetics and there after every 5 minutes until withdrawal motor block	up to 120 minutes average	Yes
Secondary	Arterial Blood Pressure	Measurements assesed every minute within the first 30 minutes after the intrathecal administration of local anesthetics and every 5 minutes until withdrawal of sensory and motor block	up to 120 minutes average	Yes