Stillborn Caesarean SectionPhase 2/3NCT01558713
Epidural Volume Extension and Intrathecal Use of Local Anesthetics in Cesarean Sections
A Phase 2/3 study testing Bupivacaine- Fentanyl - Normal Saline, Ropivacaine-Fentanyl-Normal Saline and Levobupivacaine- Fentanyl- Normal Saline in people with Stillborn Caesarean Section, run by University of Patras at 1 site in Greece.
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. Read more about this study
- Who is it for?
- Ages 18 to 40 years, women onlyHealthy volunteers can take part
- Conditions the study is for
- Stillborn Caesarean Section
- What is being tested?
- Bupivacaine- Fentanyl - Normal Saline, Ropivacaine-Fentanyl-Normal Saline and Levobupivacaine- Fentanyl- Normal Saline
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 120 participants
- Where
- 1 siteGreece
- Study dates
- Jan 2010to Dec 2012
- Phase
- Phase 2/3
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 to 40 years
- Women only
- Healthy volunteers accepted
- Adult
Who may be able to join
- Elective cesarean section
- ASA I-II
Who cannot join
- 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)
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- ASA >III
- intraoperative excessive bleeding
- patients with previous psychiatric diseases
Trial locations and contacts
1 site in 1 country.
Greece1 site, 1 recruiting
- Recruiting
Department of Anesthesiology and Intensive Care Medicine, University Hospital of Patras
Pátrai, Achaia, 26504
KRITON S FILOS, PROFESSOR, +302613603342 ext. +30, kritonfilos@yahoo.gr
Christina G Sklavou, MD, +306974337046 ext. +30, sklavou.christina@yahoo.gr
About this study
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
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.
Read the 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.
- Conditions
- Stillborn Caesarean Section
- Being tested
- Bupivacaine- Fentanyl - Normal Saline, Ropivacaine-Fentanyl-Normal Saline, Levobupivacaine- Fentanyl- Normal Saline, Bupivacaine + Fentanyl, Ropivacaine + Fentanyl
- Keywords
- parturient
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Bupivacaine- Fentanyl - Normal SalineDrug
Also called 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
Bupivacaine 0,5%, 2ml (10mg)bolus, Fentanyl 50μg/ml, 0,2ml (10 μg)bolus, Normal Saline 0,9%, 10ml bolus
Ropivacaine-Fentanyl-Normal SalineDrug
Also called Ropivacaine 0.75% :( Naropeine 7.5mg/ml, AstraZeneca), Fentanyl: 50μg/ml, Janssen-Cilag, Belgium, 0,9% Sodium Chloride Inj. BP, B.Braun Melsungen AG
Ropivacaine 0,75%, 2ml (15mg)bolus, Fentanyl 50μg/ml, 0,2ml (10 μg)bolus, Normal Saline 0,9%, 10ml bolus
Levobupivacaine- Fentanyl- Normal SalineDrug
Also called Chirocaine 5mg/ml, Abbot Laboratories, Greece, 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
Bupivacaine + FentanylDrug
Also called Bupivacaine hydrochloride 0,5% (Marcaine Spinal, 5mg/ml,AstraZeneca,Missisipi, ON, Canada), Fentanyl, 50μg/ml (Janssen-Cilag, Belgium)
Bupivacaine 0,5%, 2ml (10mg)bolus, Fentanyl 50μg/ml, 0,2ml (10 μg)bolus
Ropivacaine + FentanylDrug
Also called Ropivacaine 0,75% :(Naropeine 7,5mg/ml, AstraZeneca), Fentanyl 50μg/ml, Janssen-Cilag, Belgium.
Ropivacaine 0,75%, 2ml (15mg)bolus, Fentanyl 50μg/ml, 0,2ml (10 μg)bolus.
Levobupivacaine + FentanylDrug
Also called Chirocaine 5mg/ml, Abbot Laboratories, Greece., Fentanyl 50μg/ml, Janssen-Cilag, Belgium.
Levo-bupivacaine 0,5%, 2ml (10mg)bolus, Fentanyl 50μg/ml, 0,2ml (10 μg)bolus
| Study group | Role | What they receive |
|---|---|---|
| Group BFS | Active comparator | Group B: BUPIVACAINE 0,5% 2ml + 10μg FENTANYL(0,2ml) INTRATHECALLY, FOLLOWED BY EPIDURAL ADMINISTRATION OF 10 ml N/S 0,9% Receives: Drug: Bupivacaine- Fentanyl - Normal Saline |
| Group RFS | Active comparator | Group R : ROPIVACAINE 0,75% 2ml + 10μg FENTANYL ( 0,2ml) INTRATHECALLY, FOLLOWED BY EPIDURAL ADMINISTRATION OF 10 ml N/S 0,9% Receives: Drug: Ropivacaine-Fentanyl-Normal Saline |
| Group LFS | Active comparator | Group L: LEVO-BUPIVACAINE 0,5% 2ml + 10μg FENTANYL(0,2ml) INTRATHECALLY, FOLLOWED BY EPIDURAL ADMINISTRATION OF 10 ml N/S 0,9% Receives: Drug: Levobupivacaine- Fentanyl- Normal Saline |
| BupivacaineF | Active comparator | Group BupivacaineF: BUPIVACAINE 0,5% 2ml + 10μg FENTANYL(0,2ml) INTRATHECALLY Receives: Drug: Bupivacaine + Fentanyl |
| RopivacaineF | Active comparator | Group RopivacaineF : ROPIVACAINE 0,75% 2ml + 10μg FENTANYL ( 0,2ml) INTRATHECALLY. Receives: Drug: Ropivacaine + Fentanyl |
| LevobupivacaineF | Active comparator | Group LevobupivacaineF: LEVO-BUPIVACAINE 0,5% (2ml) + 10μg FENTANYL(0,2ml) INTRATHECALLY. Receives: Drug: Levobupivacaine + Fentanyl |
What is being measured
The primary outcome is the main question the study is designed to answer.
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
Measured: 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
Measured: up to 120 minutes average
Secondary outcomes (1)
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
Measured: up to 120 minutes average
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted20 Mar 2012 (estimated)
- Study startJan 2010
- Primary completionSep 2012 (estimated)
- Study completionDec 2012 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Stillborn Caesarean SectionStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase 2/3
- Primary purpose
- Supportive care
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Triple blind
- Who is masked
- Participant, Investigator, Outcomes assessor
- Enrolment
- 120 participants (estimated)
Sponsor and investigators
- Lead sponsor
- University of Patras
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, SKLAVOU CHRISTINA, University of Patras
- Investigators
- KRITON S FILOS, PROFESSOR, Study chair, Department of Anesthesiology and Intensive Care Medicine, University Hospital of PatrasChristina G Sklavou, MD, Principal investigator, Department of Anesthesia and Intensive Care Medicine, University Hospital of Patras
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT01558713
- Sponsor's protocol ID
- 1312010-25
- Status last verified
- Apr 2012
- First submitted
- 14 Mar 2012
- Last updated
- 27 Apr 2012
- Results posted
- No
- Data monitoring committee
- No
Study at a glance
From the registry record, last updated by the sponsor on 27 Apr 2012. Recruitment status is as the sponsor reported it: confirm with the study team.
- 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
- ClinicalTrials.gov ID
- NCT01558713
- Acronym / sponsor ID
- 1312010-25
- Conditions
- Stillborn Caesarean Section
- Keywords
- parturient
- Phase
- Phase 2/3
- Study type
- Interventional
- Recruitment status
- Unknown status
- Enrolment
- 120 participants (estimated)
- Lead sponsor
- University of PatrasUniversity, hospital or other
- Study start
- Jan 2010
- Primary completion
- Sep 2012 (estimated)
- Study completion
- Dec 2012 (estimated)
- First posted
- 20 Mar 2012 (estimated)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
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 design
- Primary purpose
- Supportive care
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Triple blind (participant, investigator, outcomes assessor)
- Number of arms
- 6
| Arm | Type | Receives |
|---|---|---|
| Group BFS | Active comparator | Drug: Bupivacaine- Fentanyl - Normal SalineGroup B: BUPIVACAINE 0,5% 2ml + 10μg FENTANYL(0,2ml) INTRATHECALLY, FOLLOWED BY EPIDURAL ADMINISTRATION OF 10 ml N/S 0,9% |
| Group RFS | Active comparator | Drug: Ropivacaine-Fentanyl-Normal SalineGroup R : ROPIVACAINE 0,75% 2ml + 10μg FENTANYL ( 0,2ml) INTRATHECALLY, FOLLOWED BY EPIDURAL ADMINISTRATION OF 10 ml N/S 0,9% |
| Group LFS | Active comparator | Drug: Levobupivacaine- Fentanyl- Normal SalineGroup L: LEVO-BUPIVACAINE 0,5% 2ml + 10μg FENTANYL(0,2ml) INTRATHECALLY, FOLLOWED BY EPIDURAL ADMINISTRATION OF 10 ml N/S 0,9% |
| BupivacaineF | Active comparator | Drug: Bupivacaine + FentanylGroup BupivacaineF: BUPIVACAINE 0,5% 2ml + 10μg FENTANYL(0,2ml) INTRATHECALLY |
| RopivacaineF | Active comparator | Drug: Ropivacaine + FentanylGroup RopivacaineF : ROPIVACAINE 0,75% 2ml + 10μg FENTANYL ( 0,2ml) INTRATHECALLY. |
| LevobupivacaineF | Active comparator | Drug: Levobupivacaine + FentanylGroup LevobupivacaineF: LEVO-BUPIVACAINE 0,5% (2ml) + 10μg FENTANYL(0,2ml) INTRATHECALLY. |
Who may qualify
- Ages
- 18 to 40 years
- Sex
- Female only
- Healthy volunteers
- Accepted
- Age groups
- Adult
Key inclusion criteria (2 listed)
- Elective cesarean section
- ASA I-II
Key exclusion criteria (9 listed)
- 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
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Bupivacaine- Fentanyl - Normal SalineAlso: 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, GermanBupivacaine 0,5%, 2ml (10mg)bolus, Fentanyl 50μg/ml, 0,2ml (10 μg)bolus, Normal Saline 0,9%, 10ml bolus | Drug | Group BFS |
| Ropivacaine-Fentanyl-Normal SalineAlso: Ropivacaine 0.75% :( Naropeine 7.5mg/ml, AstraZeneca), Fentanyl: 50μg/ml, Janssen-Cilag, Belgium, 0,9% Sodium Chloride Inj. BP, B.Braun Melsungen AGRopivacaine 0,75%, 2ml (15mg)bolus, Fentanyl 50μg/ml, 0,2ml (10 μg)bolus, Normal Saline 0,9%, 10ml bolus | Drug | Group RFS |
| Levobupivacaine- Fentanyl- Normal SalineAlso: Chirocaine 5mg/ml, Abbot Laboratories, Greece, Fentanyl, 50μg/ml, Janssen-Cilag, Belgium, 0,9% Sodium Chloride Inj. BP, B.Braun Melsungen AGLevo-bupivacaine 0,5%, 2ml (10mg)bolus, Fentanyl 50μg/ml, 0,2ml (10 μg)bolus, Normal Saline 0,9%, 10ml bolus | Drug | Group LFS |
| Bupivacaine + FentanylAlso: Bupivacaine hydrochloride 0,5% (Marcaine Spinal, 5mg/ml,AstraZeneca,Missisipi, ON, Canada), Fentanyl, 50μg/ml (Janssen-Cilag, Belgium)Bupivacaine 0,5%, 2ml (10mg)bolus, Fentanyl 50μg/ml, 0,2ml (10 μg)bolus | Drug | BupivacaineF |
| Ropivacaine + FentanylAlso: Ropivacaine 0,75% :(Naropeine 7,5mg/ml, AstraZeneca), Fentanyl 50μg/ml, Janssen-Cilag, Belgium.Ropivacaine 0,75%, 2ml (15mg)bolus, Fentanyl 50μg/ml, 0,2ml (10 μg)bolus. | Drug | RopivacaineF |
| Levobupivacaine + FentanylAlso: Chirocaine 5mg/ml, Abbot Laboratories, Greece., Fentanyl 50μg/ml, Janssen-Cilag, Belgium.Levo-bupivacaine 0,5%, 2ml (10mg)bolus, Fentanyl 50μg/ml, 0,2ml (10 μg)bolus | Drug | LevobupivacaineF |
Primary outcome
Dermatomes of Sensory block
Time frame: up to 120 minutes average
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
Motor block
Time frame: up to 120 minutes average
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
1 secondary outcome
Arterial Blood Pressure
Time frame: up to 120 minutes average
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 27 Apr 2012.
Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
KRITON S FILOS, PROFESSOR study chair
Department of Anesthesiology and Intensive Care Medicine, University Hospital of Patras
Christina G Sklavou, MD principal investigator
Department of Anesthesia and Intensive Care Medicine, University Hospital of Patras
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 2/3 study testing Bupivacaine- Fentanyl - Normal Saline, Ropivacaine-Fentanyl-Normal Saline and Levobupivacaine- Fentanyl- Normal Saline in people with Stillborn Caesarean Section, run by University of Patras at 1 site in Greece.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 2 inclusion and 9 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: status not confirmed, as of the sponsor's last update on 27 Apr 2012. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Greece. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
What does this combined phase mean?
Phase 2 studies give the treatment to a larger group to see whether it has the intended effect and to keep checking safety.
Phase 3 studies compare the treatment with the current standard treatment or a placebo in a large group, to confirm how well it works and watch for side effects.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
Are results available for this study?
Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
Contact KRITON S FILOS, PROFESSOR (+302613603341 ext. +30, kritonfilos@yahoo.gr), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Dermatomes of Sensory block (time frame: up to 120 minutes average). The study lists 2 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 27 Apr 2012.