PainNCT00808327
Spinal Anesthesia for Cesarean Delivery: Bupivacaine With or Without Fentanyl
A study testing Bupivacaine and Bupivacaine, fentanyl in people with Pain, run by Samuel Lunenfeld Research Institute, Mount Sinai Hospital at 1 site in Canada.
Trial summary
The safest form of anesthesia for Cesarean section is a spinal anesthetic. All spinal anesthetics contain a local anesthetic and/or a narcotic. A drug named bupivacaine is the most commonly used local anesthetic in spinal anesthetics for Cesarean deliveries in North America. Read more about this study
- Who is it for?
- Ages 16 to 50 years, women onlyHealthy volunteers can take part
- Conditions the study is for
- Pain
- What is being tested?
- Bupivacaine and Bupivacaine, fentanyl
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 140 participants
- Where
- 1 siteCanada
- Study dates
- Jan 2009to Aug 2009
- Phase
- Interventional
- 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 16 to 50 years
- Women only
- Healthy volunteers accepted
- Child, Adult
Who may be able to join
- healthy patients (ASA 1 or 2)
- BMI < 40
- height between 5 \& 6 feet
Who cannot join
- parturients with pregnancy induced hypertension or preeclampsia
- parturients with significant cardiac, renal or other organ-system disease which preclude choice of spinal anesthesia
- emergency delivery
- triplet or greater multiple gestation
Trial locations and contacts
1 site in 1 country.
About this study
The safest form of anesthesia for Cesarean section is a spinal anesthetic. All spinal anesthetics contain a local anesthetic and/or a narcotic. A drug named bupivacaine is the most commonly used local anesthetic in spinal anesthetics for Cesarean deliveries in North America. Another drug named fentanyl is the most commonly used narcotic. This study will look at whether a spinal anesthetic with 15mg of bupivacaine alone will be the same as a spinal anesthetic with 12mg of bupivacaine and 15ug of fentanyl.
Read the detailed description
There have been many studies looking at different doses and combinations of bupivacaine and fentanyl but there is no agreement among anesthesiologists as to the best combination of drugs.
The main problem with bupivacaine is that it causes hypotension (low blood pressure). When fentanyl is added to bupivacaine, a lower dose of bupivacaine can be used so that there is less of a fall in blood pressure. The main problem with fentanyl is itchiness and sleepiness. In the case of an emergency Cesarean section, the extra time needed to draw-up and administer a second medication may make a difference to the health of the baby.
Our goal is to determine whether high dose bupivacaine (15mg) alone will produce spinal anaesthesia for cesarean delivery equivalent to 12mg of intrathecal hyperbaric bupivacaine in combination with 15ug of intrathecal fentanyl.
- Conditions
- Pain
- Being tested
- Bupivacaine, Bupivacaine, fentanyl
- Keywords
- Cesarean section, Spinal
- Medical subject headings
- Pain
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
BupivacaineDrug
Also called Marcaine
A single, 15mg, intrathecal dose of bupivacaine.
Bupivacaine, fentanylDrug
Also called Marcaine
A single, 12 mg, intrathecal dose of bupivacaine, plus 15 micrograms of fentanyl
| Study group | Role | What they receive |
|---|---|---|
| 1 | Active comparator | Bupivacaine alone Receives: Drug: Bupivacaine |
| 2 | Active comparator | Bupivacaine plus Fentanyl Receives: Drug: Bupivacaine, fentanyl |
What is being measured
The primary outcome is the main question the study is designed to answer.
The primary outcome is the maximal degree of abdominal sensation felt by the patient during surgery.
Measured: 1 hour
Secondary outcomes (10)
Speed of onset of block to T4 dermatome (minutes), as well as highest level of block (dermatomal level) and degree of motor block (Bromage scale)
Measured: 30 minutes
The degree of patient discomfort will be evaluated using a 10 cm linear visual analog scale (VAS).
Measured: 1 hour
The amount of additional IV analgesia administered during the intraoperative period.
Measured: 1 hour
Time to regression of block (minutes)
Measured: 4 hours
Duration of analgesia (hours)
Measured: 24 hours
Incidence of side effects: Intraoperative pruritus, nausea and vomiting in the absence of hypotension, somnolence, shivering, euphoria or dysphoria and respiratory depression will be evaluated.
Measured: 2 hours
Dose of vasopressor(s) given during surgery
Measured: 1 hour
Lowest Mean Arterial Pressure during surgery (=2/3 diastolic pressure + 1/3 systolic pressure).
Measured: 1 hour
Patient satisfaction. A number of questions answered on a Likert Scale will be asked post-Cesarean section.
Measured: 15 minutes
Neonatal arterial blood gas results (pH) and 1 and 5-minute APGAR scores (1 - 10) will be recorded
Measured: 10 minutes
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted15 Dec 2008 (estimated)
- Study startJan 2009
- Primary completionAug 2009
- Study completionAug 2009
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for PainStudies 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 N/A
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Quadruple blind
- Who is masked
- Participant, Care provider, Investigator, Outcomes assessor
- Enrolment
- 140 participants (actual)
Sponsor and investigators
- Lead sponsor
- Samuel Lunenfeld Research Institute, Mount Sinai Hospital
- Sponsor type
- University, hospital or other
- Investigators
- Alison J Macarthur, MD, Principal investigator, MOUNT SINAI HOSPITAL
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT00808327
- Sponsor's protocol ID
- 08-03
- Status last verified
- Nov 2009
- First submitted
- 11 Dec 2008
- Last updated
- 20 Nov 2009
- Results posted
- No
- Data monitoring committee
- No
Study at a glance
From the registry record, last updated by the sponsor on 20 Nov 2009. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Spinal Anesthesia for Cesarean Delivery: Bupivacaine With or Without Fentanyl
- ClinicalTrials.gov ID
- NCT00808327
- Acronym / sponsor ID
- 08-03
- Conditions
- Pain
- Keywords
- Cesarean section, Spinal
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 140 participants (actual)
- Lead sponsor
- Samuel Lunenfeld Research Institute, Mount Sinai HospitalUniversity, hospital or other
- Study start
- Jan 2009
- Primary completion
- Aug 2009 (actual)
- Study completion
- Aug 2009 (actual)
- First posted
- 15 Dec 2008 (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 safest form of anesthesia for Cesarean section is a spinal anesthetic. All spinal anesthetics contain a local anesthetic and/or a narcotic. A drug named bupivacaine is the most commonly used local anesthetic in spinal anesthetics for Cesarean deliveries in North America. Another drug named fentanyl is the most commonly used narcotic. This study will look at whether a spinal anesthetic with 15mg of bupivacaine alone will be the same as a spinal anesthetic with 12mg of bupivacaine and 15ug of fentanyl.
Detailed description
There have been many studies looking at different doses and combinations of bupivacaine and fentanyl but there is no agreement among anesthesiologists as to the best combination of drugs.
The main problem with bupivacaine is that it causes hypotension (low blood pressure). When fentanyl is added to bupivacaine, a lower dose of bupivacaine can be used so that there is less of a fall in blood pressure. The main problem with fentanyl is itchiness and sleepiness. In the case of an emergency Cesarean section, the extra time needed to draw-up and administer a second medication may make a difference to the health of the baby.
Our goal is to determine whether high dose bupivacaine (15mg) alone will produce spinal anaesthesia for cesarean delivery equivalent to 12mg of intrathecal hyperbaric bupivacaine in combination with 15ug of intrathecal fentanyl.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Quadruple blind (participant, care provider, investigator, outcomes assessor)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| 1 | Active comparator | Drug: BupivacaineBupivacaine alone |
| 2 | Active comparator | Drug: Bupivacaine, fentanylBupivacaine plus Fentanyl |
Who may qualify
- Ages
- 16 to 50 years
- Sex
- Female only
- Healthy volunteers
- Accepted
- Age groups
- Child, Adult
Key inclusion criteria (3 listed)
- healthy patients (ASA 1 or 2)
- BMI < 40
- height between 5 \& 6 feet
Key exclusion criteria (4 listed)
- parturients with pregnancy induced hypertension or preeclampsia
- parturients with significant cardiac, renal or other organ-system disease which preclude choice of spinal anesthesia
- emergency delivery
- triplet or greater 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 |
|---|---|---|
| BupivacaineAlso: MarcaineA single, 15mg, intrathecal dose of bupivacaine. | Drug | 1 |
| Bupivacaine, fentanylAlso: MarcaineA single, 12 mg, intrathecal dose of bupivacaine, plus 15 micrograms of fentanyl | Drug | 2 |
Primary outcome
The primary outcome is the maximal degree of abdominal sensation felt by the patient during surgery.
Time frame: 1 hour
10 secondary outcomes
Speed of onset of block to T4 dermatome (minutes), as well as highest level of block (dermatomal level) and degree of motor block (Bromage scale)
Time frame: 30 minutes
The degree of patient discomfort will be evaluated using a 10 cm linear visual analog scale (VAS).
Time frame: 1 hour
The amount of additional IV analgesia administered during the intraoperative period.
Time frame: 1 hour
Time to regression of block (minutes)
Time frame: 4 hours
Duration of analgesia (hours)
Time frame: 24 hours
Incidence of side effects: Intraoperative pruritus, nausea and vomiting in the absence of hypotension, somnolence, shivering, euphoria or dysphoria and respiratory depression will be evaluated.
Time frame: 2 hours
Dose of vasopressor(s) given during surgery
Time frame: 1 hour
Lowest Mean Arterial Pressure during surgery (=2/3 diastolic pressure + 1/3 systolic pressure).
Time frame: 1 hour
Patient satisfaction. A number of questions answered on a Likert Scale will be asked post-Cesarean section.
Time frame: 15 minutes
Neonatal arterial blood gas results (pH) and 1 and 5-minute APGAR scores (1 - 10) will be recorded
Time frame: 10 minutes
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 20 Nov 2009.
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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.
Alison J Macarthur, MD principal investigator
MOUNT SINAI HOSPITAL
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Bupivacaine and Bupivacaine, fentanyl in people with Pain, run by Samuel Lunenfeld Research Institute, Mount Sinai Hospital at 1 site in Canada.
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 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: finished, as of the sponsor's last update on 20 Nov 2009. 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 Canada. 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.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
The primary outcome is the maximal degree of abdominal sensation felt by the patient during surgery. (time frame: 1 hour). 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 Nov 2009.