Cesarean SectionPhase 4NCT01303731
Comparison of Standard and Minidose Spinal Anesthesia for Cesarean Section Operation Using Marcaine Spinal 0.5% Heavy
A Phase 4 study testing Bupivacaine and Fentanyl and Bupivacaine in people with Cesarean Section and Anesthesia, Spinal, run by Bnai Zion Medical Center at 1 site in Israel.
Trial summary
The objectives of this study is to test a combination of low dose local anesthetic Bupivacaine diluted in patient's CSF with lipophilic opiate Fentanyl for optimal spinal anesthesia during Cesarean Section. 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
- Cesarean Section, Anesthesia, Spinal, Local Anaesthetics Causing Adverse Effects in Therapeutic Use
- What is being tested?
- Bupivacaine and Fentanyl and Bupivacaine
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 100 participants
- Where
- 1 siteIsrael
- Study dates
- Feb 2011to Jan 2012
- Phase
- Phase 4
- 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
- Women over 38 weeks of pregnancy, who read and write Hebrew
- ASA class I and II
- Age between 18 and 40 years
- Weight 50-100 kg
- Elective Cesarean Section for singlet pregnancy
Who cannot join
- Previous history of two or more Cesarean Sections
- Contraindications for regional anesthesia
- Active pain before surgery
- Non singlet pregnancy
Trial locations and contacts
1 site in 1 country.
Israel1 site
Bnai Zion Medical Center
Haifa
Boris Yanovsky, MD, boris.yanovsky@b-z.org.il
Boris Yanovsky, MD
About this study
Official title: Phase IV, Randomized, Parallel Designed, Single Blinded Study, Comparing the Standard and Minidose Spinal Anesthesia Using Marcaine Spinal 0.5% Heavy With Addition of Fentanyl During Cesarean Section
The objectives of this study is to test a combination of low dose local anesthetic Bupivacaine diluted in patient's CSF with lipophilic opiate Fentanyl for optimal spinal anesthesia during Cesarean Section. The dilution of Bupivacaine with CSF in our study would result in effective spinal anesthesia with relatively limited motor block, quick recovery of motor function and relatively long lasting analgesia. We expect lower incidence of side effects with this combination than with convenient dose of Bupivacaine.
Read the detailed description
Spinal anesthesia is the most frequent type of anesthesia used for Cesarian Section. However, despite decades of safe utilization there is still controversy about the best combination of local anesthetics and additives needed to obtain the optimal result. The objectives of this study is to test a combination of low dose local anesthetic Bupivacaine diluted in patient's CSF with lipophilic opiate Fentanyl for compliance with the criteria of optimal spinal anesthesia. Bupivacaine is the most frequently used local anesthetic in the last twenty years . It characterized by fast onset, high potency and long action . Albeit this is intrinsic characteristic of specific local anesthetic, its manifestation can be affected by concentration. It has been shown that dilution of local anesthetic with CSF can result in sensory block with less profound motor block.
Thus dilution of Bupivacaine with CSF in our study would serve double function: it would speed the recovery from the spinal anesthesia and minimize the expression of the motor block.Addition of opiates to local anesthetics has been widely used . It has been shown that this addition improves quality of spinal anesthesia and prolongs analgesia without significant prolongation of recovery from motor block.
In summary, we would use well known safe local anesthetic Bupivacaine in low dose and low concentration (after dilution with patient's CSF) in conjunction with highly lipophilic opiate Fentanyl. We suppose it will result in effective spinal anesthesia with relatively limited motor block, quick recovery of motor function and relatively long lasting analgesia. We expect lower incidence of side effect with this combination than with convenient dose of Bupivacaine.
Good pain relief and swift restoration of ability to ambulate will be important for prevention of postoperative complications, will diminish the need for systemic analgetic drugs that can affect nursing and will increase patients' satisfaction.
- Conditions
- Cesarean Section, Anesthesia, Spinal, Local Anaesthetics Causing Adverse Effects in Therapeutic Use
- Being tested
- Bupivacaine and Fentanyl, Bupivacaine
- Keywords
- Spinal anesthesia, Cesarean section, Marcaine Spinal 0.5% Heavy minidose, Fentanyl, Local Anesthetics
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Bupivacaine and FentanylDrug
Also called Marcaine Spinal 0.5% Heavy, Fentanyl-Janssen
Spinal anesthesia with Marcaine Spinal 0.5% Heavy 7.5 mg (1.5 ml) diluted in 0.75ml of patient's CSF (0.25 ml)with addition of Fentanyl 12.5 mcg (total 2.5 ml)
BupivacaineDrug
Also called Marcaine Spinal 0.5% Heavy
Spinal anesthesia with Marcaine Spinal 0.5% Heavy 12.5 mg (2.5 ml)
| Study group | Role | What they receive |
|---|---|---|
| Standard dose Marcaine Spinal 0.5% Heavy | Active comparator | Standard group - will receive spinal anesthesia induced by Marcaine Spinal 0.5% Heavy 12.5 mg (2.5 ml). Receives: Drug: Bupivacaine |
| Minidose of Marcaine Spinal 0.5% Heavy | Experimental | Minidose group - will receive spinal anesthesia induced by Marcaine Spinal 0.5% Heavy 7.5 mg (1.5 ml) diluted in 0.75ml of patient's CSF (0.25 ml)with addition of Fentanyl 12.5 mcg (total 2.5 ml) Receives: Drug: Bupivacaine and Fentanyl |
What is being measured
The primary outcome is the main question the study is designed to answer.
prominence of motor blockade
At the begining of the surgery and at the entry of the patients to PACU motor block will be evaluated
Measured: up to 2 h
Secondary outcomes (4)
operative condition
Upon completion of surgery attending surgeon will be asked to rate the operative condition.
Measured: up to 1 h
intraoperative hypotension
Number of treatments for hypotensions during the surgery will be monitored.
Measured: up to 1 h
need for postoperative pain medication
The pain or discomfort intensity during the surgery, and at PACU will be graded.
Measured: up to 2 h
general patient satisfaction
On the next day, all patients will be asked to rate their satisfaction following the anesthesia.
Measured: after 24 h
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted25 Feb 2011 (estimated)
- Study startFeb 2011
- Primary completionJan 2012 (estimated)
- Study completionJan 2012 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Cesarean 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 4
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind
- Who is masked
- Participant
- Enrolment
- 100 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Bnai Zion Medical Center
- Sponsor type
- Other government
- Investigators
- Boris Yanovsky, MD, Principal investigator, Bnai Zion Medical Center, Haifa, Israel
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT01303731
- Sponsor's protocol ID
- 0123-10-BZ
- Status last verified
- Jan 2011
- First submitted
- 20 Jan 2011
- Last updated
- 25 Feb 2011
- Results posted
- No
Study at a glance
From the registry record, last updated by the sponsor on 25 Feb 2011. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Phase IV, Randomized, Parallel Designed, Single Blinded Study, Comparing the Standard and Minidose Spinal Anesthesia Using Marcaine Spinal 0.5% Heavy With Addition of Fentanyl During Cesarean Section
- ClinicalTrials.gov ID
- NCT01303731
- Acronym / sponsor ID
- 0123-10-BZ
- Conditions
- Cesarean Section, Anesthesia, Spinal, Local Anaesthetics Causing Adverse Effects in Therapeutic Use
- Keywords
- Spinal anesthesia, Cesarean section, Marcaine Spinal 0.5% Heavy minidose, Fentanyl, Local Anesthetics
- Phase
- Phase 4
- Study type
- Interventional
- Recruitment status
- Unknown status
- Enrolment
- 100 participants (estimated)
- Lead sponsor
- Bnai Zion Medical CenterOther government
- Study start
- Feb 2011
- Primary completion
- Jan 2012 (estimated)
- Study completion
- Jan 2012 (estimated)
- First posted
- 25 Feb 2011 (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 objectives of this study is to test a combination of low dose local anesthetic Bupivacaine diluted in patient's CSF with lipophilic opiate Fentanyl for optimal spinal anesthesia during Cesarean Section. The dilution of Bupivacaine with CSF in our study would result in effective spinal anesthesia with relatively limited motor block, quick recovery of motor function and relatively long lasting analgesia. We expect lower incidence of side effects with this combination than with convenient dose of Bupivacaine.
Detailed description
Spinal anesthesia is the most frequent type of anesthesia used for Cesarian Section. However, despite decades of safe utilization there is still controversy about the best combination of local anesthetics and additives needed to obtain the optimal result. The objectives of this study is to test a combination of low dose local anesthetic Bupivacaine diluted in patient's CSF with lipophilic opiate Fentanyl for compliance with the criteria of optimal spinal anesthesia. Bupivacaine is the most frequently used local anesthetic in the last twenty years . It characterized by fast onset, high potency and long action . Albeit this is intrinsic characteristic of specific local anesthetic, its manifestation can be affected by concentration. It has been shown that dilution of local anesthetic with CSF can result in sensory block with less profound motor block.
Thus dilution of Bupivacaine with CSF in our study would serve double function: it would speed the recovery from the spinal anesthesia and minimize the expression of the motor block.Addition of opiates to local anesthetics has been widely used . It has been shown that this addition improves quality of spinal anesthesia and prolongs analgesia without significant prolongation of recovery from motor block.
In summary, we would use well known safe local anesthetic Bupivacaine in low dose and low concentration (after dilution with patient's CSF) in conjunction with highly lipophilic opiate Fentanyl. We suppose it will result in effective spinal anesthesia with relatively limited motor block, quick recovery of motor function and relatively long lasting analgesia. We expect lower incidence of side effect with this combination than with convenient dose of Bupivacaine.
Good pain relief and swift restoration of ability to ambulate will be important for prevention of postoperative complications, will diminish the need for systemic analgetic drugs that can affect nursing and will increase patients' satisfaction.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind (participant)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Standard dose Marcaine Spinal 0.5% Heavy | Active comparator | Drug: BupivacaineStandard group - will receive spinal anesthesia induced by Marcaine Spinal 0.5% Heavy 12.5 mg (2.5 ml). |
| Minidose of Marcaine Spinal 0.5% Heavy | Experimental | Drug: Bupivacaine and FentanylMinidose group - will receive spinal anesthesia induced by Marcaine Spinal 0.5% Heavy 7.5 mg (1.5 ml) diluted in 0.75ml of patient's CSF (0.25 ml)with addition of Fentanyl 12.5 mcg (total 2.5 ml) |
Who may qualify
- Ages
- 18 to 40 years
- Sex
- Female only
- Healthy volunteers
- Accepted
- Age groups
- Adult
Key inclusion criteria (5 listed)
- Women over 38 weeks of pregnancy, who read and write Hebrew
- ASA class I and II
- Age between 18 and 40 years
- Weight 50-100 kg
- Elective Cesarean Section for singlet pregnancy
Key exclusion criteria (4 listed)
- Previous history of two or more Cesarean Sections
- Contraindications for regional anesthesia
- Active pain before surgery
- Non singlet pregnancy
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 and FentanylAlso: Marcaine Spinal 0.5% Heavy, Fentanyl-JanssenSpinal anesthesia with Marcaine Spinal 0.5% Heavy 7.5 mg (1.5 ml) diluted in 0.75ml of patient's CSF (0.25 ml)with addition of Fentanyl 12.5 mcg (total 2.5 ml) | Drug | Minidose of Marcaine Spinal 0.5% Heavy |
| BupivacaineAlso: Marcaine Spinal 0.5% HeavySpinal anesthesia with Marcaine Spinal 0.5% Heavy 12.5 mg (2.5 ml) | Drug | Standard dose Marcaine Spinal 0.5% Heavy |
Primary outcome
prominence of motor blockade
Time frame: up to 2 h
At the begining of the surgery and at the entry of the patients to PACU motor block will be evaluated
4 secondary outcomes
operative condition
Time frame: up to 1 h
intraoperative hypotension
Time frame: up to 1 h
need for postoperative pain medication
Time frame: up to 2 h
general patient satisfaction
Time frame: after 24 h
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 25 Feb 2011.
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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.
Boris Yanovsky, MD principal investigator
Bnai Zion Medical Center, Haifa, Israel
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 4 study testing Bupivacaine and Fentanyl and Bupivacaine in people with Cesarean Section and Anesthesia, Spinal, run by Bnai Zion Medical Center at 1 site in Israel.
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 5 inclusion and 4 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 25 Feb 2011. 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 Israel. 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 phase mean?
Phase 4 studies take place after a treatment is approved, to learn more about its long-term benefits and risks in everyday use.
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 Boris Yanovsky, MD (+972 50 626788, boris.yanovsky@b-z.org.il), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
prominence of motor blockade (time frame: up to 2 h). 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 25 Feb 2011.