A Phase 2/3 interventional study of Bupivacaine- Fentanyl - Normal Saline and Ropivacaine-Fentanyl-Normal Saline in Stillborn Caesarean Section, sponsored by University of Patras. Status unknown at 1 site in Greece. Open to female participants aged 18 Years to 40 Years, including healthy volunteers. Per ClinicalTrials.gov, last updated 2012-04-27.
Sponsored by University of Patras · Phase 2/3, Interventional, and Supportive care
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.
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.
117 studies on the registry are indexed under Stillbirth; 33 are open to participants now.
This study's planned enrollment of 120 is below the median of 275 across 66 interventional studies indexed under Stillbirth.
Browse Stillbirth studies →University of Patras is the lead sponsor of 69 studies on the registry; 10 are open to participants now.
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Exclusion Criteria:
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
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
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
Group BupivacaineF: BUPIVACAINE 0,5% 2ml + 10μg FENTANYL(0,2ml) INTRATHECALLY
Drug: Bupivacaine + Fentanyl
Group RopivacaineF : ROPIVACAINE 0,75% 2ml + 10μg FENTANYL ( 0,2ml) INTRATHECALLY.
Drug: Ropivacaine + Fentanyl
Group LevobupivacaineF: LEVO-BUPIVACAINE 0,5% (2ml) + 10μg FENTANYL(0,2ml) INTRATHECALLY.
Drug: Levobupivacaine + Fentanyl
Bupivacaine 0,5%, 2ml (10mg)bolus, Fentanyl 50μg/ml, 0,2ml (10 μg)bolus, Normal Saline 0,9%, 10ml bolus
Also known as: Bupivacaine hydrochloride 0.5% ( Marcaine Spinal, 5 mg/ml, AstraZeneca, Missisipi, ON, Canada), Fentanyl, 50μg/ml, Janssen-Cilag, Belgium, 0,9% Sodium Chloride Inj. BP, B.BRAUN Melsungen AG, German
Ropivacaine 0,75%, 2ml (15mg)bolus, Fentanyl 50μg/ml, 0,2ml (10 μg)bolus, Normal Saline 0,9%, 10ml bolus
Also known as: Ropivacaine 0.75% :( Naropeine 7.5mg/ml, AstraZeneca), Fentanyl: 50μg/ml, Janssen-Cilag, Belgium, 0,9% Sodium Chloride Inj. BP, B.Braun Melsungen AG
Levo-bupivacaine 0,5%, 2ml (10mg)bolus, Fentanyl 50μg/ml, 0,2ml (10 μg)bolus, Normal Saline 0,9%, 10ml bolus
Also known as: Chirocaine 5mg/ml, Abbot Laboratories, Greece, Fentanyl, 50μg/ml, Janssen-Cilag, Belgium, 0,9% Sodium Chloride Inj. BP, B.Braun Melsungen AG
Bupivacaine 0,5%, 2ml (10mg)bolus, Fentanyl 50μg/ml, 0,2ml (10 μg)bolus
Also known as: Bupivacaine hydrochloride 0,5% (Marcaine Spinal, 5mg/ml,AstraZeneca,Missisipi, ON, Canada), Fentanyl, 50μg/ml (Janssen-Cilag, Belgium)
Ropivacaine 0,75%, 2ml (15mg)bolus, Fentanyl 50μg/ml, 0,2ml (10 μg)bolus.
Also known as: Ropivacaine 0,75% :(Naropeine 7,5mg/ml, AstraZeneca), Fentanyl 50μg/ml, Janssen-Cilag, Belgium.
Levo-bupivacaine 0,5%, 2ml (10mg)bolus, Fentanyl 50μg/ml, 0,2ml (10 μg)bolus
Also known as: Chirocaine 5mg/ml, Abbot Laboratories, Greece., Fentanyl 50μg/ml, Janssen-Cilag, Belgium.
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
Time frame: 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
Time frame: up to 120 minutes average
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
Time frame: up to 120 minutes average
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