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

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

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.

Study Overview

• Status: Unknown
• Conditions: Stillborn Caesarean Section
• Intervention / Treatment: Drug: Bupivacaine- Fentanyl - Normal Saline; Drug: Ropivacaine-Fentanyl-Normal Saline; Drug: Levobupivacaine- Fentanyl- Normal Saline; Drug: Bupivacaine + Fentanyl; Drug: Ropivacaine + Fentanyl; Drug: Levobupivacaine + Fentanyl

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.

• Study Type: Interventional
• Enrollment (Anticipated): 120
• Phase: Phase 2; Phase 3

Contacts and Locations

• Study Contact: Name: KRITON S FILOS, PROFESSOR; Phone Number: +30 +302613603341; Email: kritonfilos@yahoo.gr
• Study Contact Backup: Name: CHRISTINA G SKLAVOU, MD; Phone Number: +302613603346; Email: sklavou.christina@yahoo.gr

Study Locations

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

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 18 years to 40 years (Adult)
• Accepts Healthy Volunteers: Yes
• Genders Eligible for Study: Female

Description

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 Plan

How is the study designed?

Design Details

• Primary Purpose: Supportive Care
• Allocation: Randomized
• Interventional Model: Parallel Assignment
• Masking: Triple

Number of Arms

6

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Active Comparator: Group BFS; Group B: BUPIVACAINE 0,5% 2ml + 10μg FENTANYL(0,2ml) INTRATHECALLY, FOLLOWED BY EPIDURAL ADMINISTRATION OF 10 ml N/S 0,9%	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; Other Names: Fentanyl, 50μg/ml, Janssen-Cilag, Belgium; Bupivacaine hydrochloride 0.5% ( Marcaine Spinal, 5 mg/ml, AstraZeneca, Missisipi, ON, Canada); 0,9% Sodium Chloride Inj. BP, B.BRAUN Melsungen AG, German
Active Comparator: Group RFS; Group R : ROPIVACAINE 0,75% 2ml + 10μg FENTANYL ( 0,2ml) INTRATHECALLY, FOLLOWED BY EPIDURAL ADMINISTRATION OF 10 ml N/S 0,9%	Drug: Ropivacaine-Fentanyl-Normal Saline; Ropivacaine 0,75%, 2ml (15mg)bolus, Fentanyl 50μg/ml, 0,2ml (10 μg)bolus, Normal Saline 0,9%, 10ml bolus; Other Names: Ropivacaine 0.75% :( Naropeine 7.5mg/ml, AstraZeneca); Fentanyl: 50μg/ml, Janssen-Cilag, Belgium; 0,9% Sodium Chloride Inj. BP, B.Braun Melsungen AG
Active Comparator: Group LFS; Group L: LEVO-BUPIVACAINE 0,5% 2ml + 10μg FENTANYL(0,2ml) INTRATHECALLY, FOLLOWED BY EPIDURAL ADMINISTRATION OF 10 ml N/S 0,9%	Drug: 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; Other Names: Fentanyl, 50μg/ml, Janssen-Cilag, Belgium; 0,9% Sodium Chloride Inj. BP, B.Braun Melsungen AG; Chirocaine 5mg/ml, Abbot Laboratories, Greece
Active Comparator: BupivacaineF; Group BupivacaineF: BUPIVACAINE 0,5% 2ml + 10μg FENTANYL(0,2ml) INTRATHECALLY	Drug: Bupivacaine + Fentanyl; Bupivacaine 0,5%, 2ml (10mg)bolus, Fentanyl 50μg/ml, 0,2ml (10 μg)bolus; Other Names: Bupivacaine hydrochloride 0,5% (Marcaine Spinal, 5mg/ml,AstraZeneca,Missisipi, ON, Canada); Fentanyl, 50μg/ml (Janssen-Cilag, Belgium)
Active Comparator: RopivacaineF; Group RopivacaineF : ROPIVACAINE 0,75% 2ml + 10μg FENTANYL ( 0,2ml) INTRATHECALLY.	Drug: Ropivacaine + Fentanyl; Ropivacaine 0,75%, 2ml (15mg)bolus, Fentanyl 50μg/ml, 0,2ml (10 μg)bolus.; Other Names: Ropivacaine 0,75% :(Naropeine 7,5mg/ml, AstraZeneca); Fentanyl 50μg/ml, Janssen-Cilag, Belgium.
Active Comparator: LevobupivacaineF; Group LevobupivacaineF: LEVO-BUPIVACAINE 0,5% (2ml) + 10μg FENTANYL(0,2ml) INTRATHECALLY.	Drug: Levobupivacaine + Fentanyl; Levo-bupivacaine 0,5%, 2ml (10mg)bolus, Fentanyl 50μg/ml, 0,2ml (10 μg)bolus; Other Names: Fentanyl 50μg/ml, Janssen-Cilag, Belgium.; Chirocaine 5mg/ml, Abbot Laboratories, Greece.

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
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
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

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
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

Collaborators and Investigators

• Sponsor: University of Patras
• Investigators: Study Chair: KRITON S FILOS, PROFESSOR, Department of Anesthesiology and Intensive Care Medicine, University Hospital of Patras; Principal Investigator: Christina G Sklavou, MD, Department of Anesthesia and Intensive Care Medicine, University Hospital of Patras

Study record dates

Study Major Dates

• Study Start: January 1, 2010
• Primary Completion (Anticipated): September 1, 2012
• Study Completion (Anticipated): December 1, 2012

Study Registration Dates

• First Submitted: March 14, 2012
• First Submitted That Met QC Criteria: March 19, 2012
• First Posted (Estimate): March 20, 2012

Study Record Updates

• Last Update Posted (Estimate): April 27, 2012
• Last Update Submitted That Met QC Criteria: April 26, 2012
• Last Verified: April 1, 2012

More Information

Terms related to this study

• Keywords: parturient
• Additional Relevant MeSH Terms: Pathologic Processes; Pregnancy Complications; Death; Fetal Death; Stillbirth; Physiological Effects of Drugs; Central Nervous System Depressants; Peripheral Nervous System Agents; Analgesics; Sensory System Agents; Anesthetics, Intravenous; Anesthetics, General; Anesthetics; Analgesics, Opioid; Narcotics; Adjuvants, Anesthesia; Anesthetics, Local; Fentanyl; Bupivacaine; Ropivacaine; Levobupivacaine
• Other Study ID Numbers: 1312010-25