Stillborn Caesarean SectionPhase 2/3NCT01582607
Subarachnoid Administration of Levobupivacaine for Cesarean Section
A Phase 2/3 study testing Bupivacaine plain, Ropivacaine plain and Levobupivacaine plain in people with Stillborn Caesarean Section, run by University of Patras at 1 site in Greece.
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. 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 plain, Ropivacaine plain and Levobupivacaine plain
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 130 participants
- Where
- 1 siteGreece
- Study dates
- Jan 2010to May 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
- Parturients scheduled for elective c section
- Stillborn
- Normal cardiotocogram
Who cannot join
- BMI>35kg/m2
- Height <150cm or >185cm
- Age (<18, >40)
- ASA > II
- Multiple gestation
- Pregnancy complications (eclampsia, GDP, placenta previa, >2 previous c section)
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- Contraindication to spinal anaesthesia
- Failure to educate the patient, language barrier
- Patient preferred GA
Trial locations and contacts
1 site in 1 country.
Greece1 site, 1 recruiting
- Recruiting
University Hospital of Patras, Department of Anesthesiology
Pátrai, Achaia, 26504
Kriton S Filos, Professor, +302610999341, kritonfilos@yahoo.gr
Nikolaos G Flaris, MD, +306936622601, nflaris@yahoo.gr
About this study
Official title: Intrathecal Plain Bupivacaine, Ropivacaine and Levo-bupivacaine With or Without Fentanyl for Elective c Section.
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.
Read the detailed 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.
- Conditions
- Stillborn Caesarean Section
- Being tested
- Bupivacaine plain, Ropivacaine plain, Levobupivacaine plain, bupivacaine plain +fentanyl, ropivacaine plain +. fentanyl
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Bupivacaine plainDrug
Also called Marcaine Spinal 5 mg/ml, AstraZeneca
2.0 mL (10mg) plain bupivacaine hydrochloride 0.5% intrathecally
Ropivacaine plainDrug
Also called Naropeine 7.5mg/ml, AstraZeneca
2.0 ml (15mg) plain ropivacaine 0.75% intrathecally
Levobupivacaine plainDrug
Also called Chirocaine 5mg/ml, Abbott Laboratories
2.0 ml (10mg) plain levo-bupivacaine hydrochloride 0.5% intrathecally
bupivacaine plain +fentanylDrug
Also called Marcaine Spinal 5 mg/ml, Fentanyl, 50μg/ml, Janssen-Cilag, Belgium
2.0 ml (10mg) plain bupivacaine 0.5% with 0.2 ml (10 μg) fentanyl intrathecally
ropivacaine plain +. fentanylDrug
Also called Naropeine 7.5mg/ml, AstraZeneca, Fentanyl, 50μg/ml, Janssen-Cilag, Belgium
2.0 ml (15mg) plain ropivacaine 0.75% with 0.2 ml (10 μg) fentanyl intrathecally
Levobupivacaine plain +fentanylDrug
Also called Chirocaine 5mg/ml, Abbott laboratories, Fentanyl, 50μg/ml, Janssen-Cilag, Belgium
2.0 ml (10mg) plain levo-bupivacaine 0.5% with 0.2 ml (10 μg) fentanyl intrathecally
| Study group | Role | What they receive |
|---|---|---|
| Group B | Active comparator | subarachnoid administration of 2.0 mL (10mg) plain bupivacaine hydrochloride 0.5% Receives: Drug: Bupivacaine plain |
| Group R | Active comparator | subarachnoid administration of 2.0 ml (15mg) plain ropivacaine 0.75% Receives: Drug: Ropivacaine plain |
| Group LB | Active comparator | subarachnoid administration of 2.0 ml (10mg) plain levo-bupivacaine hydrochloride 0.5% Receives: Drug: Levobupivacaine plain |
| Group RF | Active comparator | subarachnoid administration of 2.0 ml (15mg) plain ropivacaine 0.75% with 0.2 ml (10 μg) fentanyl Receives: Drug: ropivacaine plain +. fentanyl |
| Group BF | Active comparator | subarachnoid administration of 2.0 ml (10mg) plain bupivacaine 0.5% with 0.2 ml (10 μg) fentanyl Receives: Drug: bupivacaine plain +fentanyl |
| Group LBF | Active comparator | subarachnoid administration of 2.0 ml (10mg) plain levo-bupivacaine 0.5% with 0.2 ml (10 μg) fentanyl Receives: Drug: Levobupivacaine plain +fentanyl |
What is being measured
The primary outcome is the main question the study is designed to answer.
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)
Measured: up to 150 minutes average
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)
Measured: up to 150 minutes
Secondary outcomes (1)
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)
Measured: up to 150 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 Apr 2012 (estimated)
- Study startJan 2010
- Primary completionApr 2012 (estimated)
- Study completionMay 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
- Double blind
- Who is masked
- Investigator, Outcomes assessor
- Enrolment
- 130 participants (estimated)
Sponsor and investigators
- Lead sponsor
- University of Patras
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Nikolaos G. Flaris, University of Patras
- Investigators
- Nikolaos G Flaris, MD, Principal investigator, University Hospital of PatrasKriton S Filos, Professor, Study director, University Hospital of Patras
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT01582607
- Sponsor's protocol ID
- 3089
- Status last verified
- Apr 2012
- First submitted
- 14 Apr 2012
- Last updated
- 20 Apr 2012
- Results posted
- No
- Data monitoring committee
- Yes
Study at a glance
From the registry record, last updated by the sponsor on 20 Apr 2012. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Intrathecal Plain Bupivacaine, Ropivacaine and Levo-bupivacaine With or Without Fentanyl for Elective c Section.
- ClinicalTrials.gov ID
- NCT01582607
- Acronym / sponsor ID
- 3089
- Conditions
- Stillborn Caesarean Section
- Phase
- Phase 2/3
- Study type
- Interventional
- Recruitment status
- Unknown status
- Enrolment
- 130 participants (estimated)
- Lead sponsor
- University of PatrasUniversity, hospital or other
- Study start
- Jan 2010
- Primary completion
- Apr 2012 (estimated)
- Study completion
- May 2012 (estimated)
- First posted
- 20 Apr 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.
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.
Detailed 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.
Study design
- Primary purpose
- Supportive care
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Double blind (investigator, outcomes assessor)
- Number of arms
- 6
| Arm | Type | Receives |
|---|---|---|
| Group B | Active comparator | Drug: Bupivacaine plainsubarachnoid administration of 2.0 mL (10mg) plain bupivacaine hydrochloride 0.5% |
| Group R | Active comparator | Drug: Ropivacaine plainsubarachnoid administration of 2.0 ml (15mg) plain ropivacaine 0.75% |
| Group LB | Active comparator | Drug: Levobupivacaine plainsubarachnoid administration of 2.0 ml (10mg) plain levo-bupivacaine hydrochloride 0.5% |
| Group RF | Active comparator | Drug: ropivacaine plain +. fentanylsubarachnoid administration of 2.0 ml (15mg) plain ropivacaine 0.75% with 0.2 ml (10 μg) fentanyl |
| Group BF | Active comparator | Drug: bupivacaine plain +fentanylsubarachnoid administration of 2.0 ml (10mg) plain bupivacaine 0.5% with 0.2 ml (10 μg) fentanyl |
| Group LBF | Active comparator | Drug: Levobupivacaine plain +fentanylsubarachnoid administration of 2.0 ml (10mg) plain levo-bupivacaine 0.5% with 0.2 ml (10 μg) fentanyl |
Who may qualify
- Ages
- 18 to 40 years
- Sex
- Female only
- Healthy volunteers
- Accepted
- Age groups
- Adult
Key inclusion criteria (3 listed)
- Parturients scheduled for elective c section
- Stillborn
- Normal cardiotocogram
Key exclusion criteria (9 listed)
- BMI>35kg/m2
- Height <150cm or >185cm
- Age (<18, >40)
- ASA > II
- Multiple gestation
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 plainAlso: Marcaine Spinal 5 mg/ml, AstraZeneca2.0 mL (10mg) plain bupivacaine hydrochloride 0.5% intrathecally | Drug | Group B |
| Ropivacaine plainAlso: Naropeine 7.5mg/ml, AstraZeneca2.0 ml (15mg) plain ropivacaine 0.75% intrathecally | Drug | Group R |
| Levobupivacaine plainAlso: Chirocaine 5mg/ml, Abbott Laboratories2.0 ml (10mg) plain levo-bupivacaine hydrochloride 0.5% intrathecally | Drug | Group LB |
| bupivacaine plain +fentanylAlso: Marcaine Spinal 5 mg/ml, Fentanyl, 50μg/ml, Janssen-Cilag, Belgium2.0 ml (10mg) plain bupivacaine 0.5% with 0.2 ml (10 μg) fentanyl intrathecally | Drug | Group BF |
| ropivacaine plain +. fentanylAlso: Naropeine 7.5mg/ml, AstraZeneca, Fentanyl, 50μg/ml, Janssen-Cilag, Belgium2.0 ml (15mg) plain ropivacaine 0.75% with 0.2 ml (10 μg) fentanyl intrathecally | Drug | Group RF |
| Levobupivacaine plain +fentanylAlso: Chirocaine 5mg/ml, Abbott laboratories, Fentanyl, 50μg/ml, Janssen-Cilag, Belgium2.0 ml (10mg) plain levo-bupivacaine 0.5% with 0.2 ml (10 μg) fentanyl intrathecally | Drug | Group LBF |
Primary outcome
Sensory block
Time frame: up to 150 minutes average
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)
Motor block
Time frame: up to 150 minutes
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)
1 secondary outcome
Hemodynamics profile (arterial pressure. heart rate)
Time frame: up to 150 minutes average
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 20 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.
Nikolaos G Flaris, MD principal investigator
University Hospital of Patras
Kriton S Filos, Professor study director
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 plain, Ropivacaine plain and Levobupivacaine plain 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 3 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 20 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 (2610999341 ext. 0030, kritonfilos@yahoo.gr), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Sensory block (time frame: up to 150 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 20 Apr 2012.