Complications; Cesarean SectionNCT02036697
Hemodynamic Effects of Low Dose Spinal Anesthesia for Cesarean Section
A study testing Bupivacaine 4.5, Bupivacaine 9 and Morphine in people with Complications; Cesarean Section and Effects of; Anesthesia, Spinal and Epidural, in Pregnancy, run by University of Manitoba at 1 site in Canada.
Trial summary
We propose to study the effects on hemodynamics (blood pressure, cardiac output, and central venous pressure) of two doses of bupivacaine for spinal anesthesia during cesarean section: a higher dose of 12 mg to a lower dose of 4.5 mg. Read more about this study
- Who is it for?
- Ages 18 to 40 years, women only
- Conditions the study is for
- Complications; Cesarean Section, Effects of; Anesthesia, Spinal and Epidural, in Pregnancy, Hemodynamic Instability
- What is being tested?
- Bupivacaine 4.5, Bupivacaine 9 and Morphine
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 30 participants
- Where
- 1 siteCanada
- Study dates
- Nov 2013to Dec 2015
- 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 18 to 40 years
- Women only
- No healthy volunteers
- Adult
Who may be able to join
- Adult females having elective, repeat cesarean sections who have given informed consent.
Who cannot join
- • Contraindications to dural puncture
- BMI >40
- Elective C/S presenting in labour or with rupture of membranes
- Placenta previa or accrete
Trial locations and contacts
1 site in 1 country.
About this study
We propose to study the effects on hemodynamics (blood pressure, cardiac output, and central venous pressure) of two doses of bupivacaine for spinal anesthesia during cesarean section: a higher dose of 12 mg to a lower dose of 4.5 mg. We will examine recovery times, incidence of hypotension, and compare pain control and maternal satisfaction during and after cesarean section.
We hypothesize that low dose bupivacaine spinal anesthesia will provide equivalent anesthesia for cesarean section compared to conventional dose bupivacaine, with less hypotension, faster recovery time, and enhanced maternal satisfaction. Maternal satisfaction will be assessed by self-reported pain scores, incidence of nausea and vomiting, shivering, and ability to interact with baby in the OR.
Read the detailed description
Hypothesis
It is hypothesized that low dose spinal anesthesia can provide equivalent anesthesia for cesarean section as higher conventional dose spinal anesthesia, with less hypotension, faster recovery and enhanced maternal satisfaction.
Patient Population
Adult females having elective, repeat cesarean sections who have given informed consent.
Exclusion Criteria
- Contraindications to dural puncture
- BMI >40
- Elective C/S presenting in labour or with rupture of membranes
- Placenta previa or accrete
Methodology
Patients will be screened in the antenatal clinic at Women's Hospital, Health Sciences Centre (HSC), Winnipeg during one of their regularly scheduled visits. If patients are scheduled at another antenatal clinic in the city, we will ask the obstetrician to briefly mention the study to potential study patients, and if they are interested give them the consent form to take home and read. We will then phone patients, obtain verbal consent and discuss any questions they may have. On the morning of their procedure we will obtain written consent, and answer any additional questions they may have. Alternatively, patients will be approached by their obstetrician in clinic, and if interested will be given the option to go to the Pre-Anesthesia Clinic at HSC where a member of our study team will discuss the study with them and obtain written consent.
Potential patients will be provided with information regarding the study and consent will be obtained prior to their enrollment in the study. Forty patients will be randomized into two groups: 1. Conventional dose spinal anesthesia 2. Low dose spinal anesthesia. Randomization will occur via sealed envelope prior to their scheduled cesarean section. The patient will be blinded to the randomization.
All women will have standard monitors. In addition, a radial arterial line will be inserted for continuous blood pressure measurement and cardiac output measurements using the FloTrac sensor and Vigileo monitor(cardiac output monitor using arterial waveform analysis, Edwards Life Sciences). All women will receive a preload of 500ml of Ringers Lactate solution intravenously.
The conventional dose control group will receive a spinal anesthetic consisting of hyperbaric bupivacaine 1.2cc (9mg) with fentanyl 15mg and preservative free morphine 150mcg. The patient will be in the sitting position for the dural puncture and then positioned supine, in the left lateral tilt position after the anesthetic solution has been given. Once block height has been established the patient will be placed in 20-30 degrees trendelenberg for the cesarean section.
The low-dose spinal group will receive a spinal anesthetic consisting of hyperbaric bupivacaine 4.5mg with fentanyl 15mg and preservative free morphine 150mcg. The patient will be positioned on her side, right side down and head down 20-30 degrees for the dural puncture and then positioned supine in the left lateral tilt position after the anesthetic solution has been given. The OR table will be kept in 20-30 degrees head down for the cesarean section.
Blood pressure will be monitored continuously. Cardiac output measurement will be done immediately prior to administering the spinal and immediately after positioning in a left lateral tilt position and then every five minutes until the end of the operation.
All women will be instructed in the use of a patient controlled analgesia (PCA) remifentanil infusion which they can use during the cesarean section if they experience any discomfort. If this is not adequate, 60-70% nitrous oxide will be attempted. If adequate pain control cannot be established and the cesarean section is not near completion, conversion to a general anesthetic will be the next step. All women will receive rectal naproxen at the conclusion of the surgery unless there is a contraindication or bleeding is a concern. All women will receive prophylactic ondansetron intraoperatively unless there is a contraindication.
Decreases in mean blood pressure greater than 20% from baseline or less than 90 mm Hg will be defined as hypotension and will be treated with incremental doses of phenylephrine (50-100mcg IV) or ephedrine (5mg) if maternal heart rate is less than 60 bpm. A 500cc lactated ringers bolus will be co-administered with initiation of the spinal anesthetic. Further fluids will be administered with a goal of approximately 1-1.5 liters intraoperatively. Each patient will in addition receive 20 units Oxytocin in 500cc saline. Additional fluid or uterotonics will be given as necessary for bleeding or hypotension and will be taken into account at the end.
Levels of sensory and motor blockade will be recorded just prior to skin prep, following arrival in recovery room and then every 30 minutes thereafter. Sensory block will be monitored by dermatome level at which there is a loss of sensation to ice. Motor blockade will be checked using the modified Bromage score (0 = no impairment, 1 = unable to raise extended legs but able to move knees and ankles, 2 = unable to raise extended legs or to flex knees but able to move feet, 3 = unable to flex ankles, knees or hips).
Maternal satisfaction will be assessed as self reported pain scores, nausea/vomiting, shivering, ability to interact with baby in the OR.
Outcome measures will include the following
- Hemodynamics (BP, heart rate (HR), Cardiac Index)
- Time to completion of spinal anesthetic (from skin puncture to positioning in the left lateral tilt position)
- Surgical time (skin incision to skin closure)
- Total remifentanil administration during the procedure
- Total phenylephrine administration during the procedure
- Administration of any other sedatives/anti-emetics
- Fetal cord blood gases (arterial and venous) and Apgar scores
- Maternal satisfaction scores
- Bilateral sensory block levels Bromage scores on arrival to PACU and every 30 minutes until the patient is discharge ready
- Time to being discharge ready from PACU
- Complications (difficult spinal, PDPH)
Outcome 1 to 6 will be recorded intraoperatively (average time 90 to 120 minutes). Outcomes 6 to 10 will be recorded in the post anesthesia care unit (PACU)(average stay 4 to 6 hours). Outcome 11 will be recorded for the duration of the patient's hospital stay.
Patients will be followed for the duration of their hospital stay (estimated three days).
Statistical Analysis
Statistical analysis will be done by the Biostatistical Consulting Unit of the University of Manitoba. It will consist of analysis of variance for repeated measures for continuous variables, student's T-test and Chi square analysis for non-parametric variables. P<0.05 will be considered statistically significant.
We propose to study 20 patients in each group.
- Conditions
- Complications; Cesarean Section, Effects of; Anesthesia, Spinal and Epidural, in Pregnancy, Hemodynamic Instability, Personal Satisfaction
- Keywords
- Cesarean section, spinal anesthesia, low dose spinal, bupivacaine, hemodynamics, blood pressure, cardiac output
- Medical subject headings
- Personal Satisfaction
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Bupivacaine 4.5Drug
Bupivacaine hyperbaric, 4.5 mg
Bupivacaine 9Drug
Bupivacaine hyperbaric, 9 mg
MorphineDrug
morphine 150 mcg.
FentanylDrug
15 mcg
| Study group | Role | What they receive |
|---|---|---|
| Low Dose Spinal | Experimental | Hyperbaric bupivacaine 4.5mg with fentanyl 15mcg and preservative free morphine 150mcg.
The patient will be positioned right side down and head down 20-30 degrees for the dural puncture and then positioned supine in the left lateral tilt position after the anesthetic solution has been given. The OR table will be kept in 20-30 degrees head down for the cesarean section. Receives: Drug: Bupivacaine 4.5; Drug: Morphine; Drug: Fentanyl |
| Control Spinal Group | Active comparator | Hyperbaric bupivacaine 1.2cc (9mg) with fentanyl 15mcg and preservative free morphine 150mcg.
The patient will be in the sitting position for the dural puncture and then positioned supine, in the left lateral tilt position after the anesthetic solution has been given. Once block height has been established the patient will be placed in 20-30 degrees trendelenberg for the cesarean section. Receives: Drug: Bupivacaine 9; Drug: Morphine; Drug: Fentanyl |
What is being measured
The primary outcome is the main question the study is designed to answer.
Recovery room length of stay
The primary endpoint is the expected reduction in the Recovery Room length of stay. Based on a predicted 50-100% reduction in length of stay, alpha 0.05, power of 80%, and given an anticipated drop-out rate of 10%, a sample size of n = 20 study patients per group is required.
Measured: Current recovery room average length of stay is 4 hours
Secondary outcomes (1)
Hemodynamics
Intraoperative management during Cesarean section, Hemodynamics (BP, HR, Cardiac Index)
Measured: Average duration of surgery is 100 minutes
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted15 Jan 2014 (estimated)
- Study startNov 2013
- Primary completionJun 2014
- Study completionDec 2015
Why it stopped: Difficulty with patient recruitment.
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Complications; Cesarean SectionStudies of the same condition, open and under way.
- More trials run by University of ManitobaThe sponsor's other registered studies.
- 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
- Allocation
- Randomised
- Intervention model
- Single group
- Masking
- Double blind
- Who is masked
- Participant, Outcomes assessor
- Enrolment
- 30 participants (actual)
Sponsor and investigators
- Lead sponsor
- University of Manitoba
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
- Investigators
- Stephen E Kowalski, MD, Principal investigator, University of Manitoba
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT02036697
- Sponsor's protocol ID
- B2013060
- Status last verified
- May 2016
- First submitted
- 26 Sep 2013
- Last updated
- 8 Nov 2016
- Results posted
- No
- Data monitoring committee
- No
Study at a glance
From the registry record, last updated by the sponsor on 8 Nov 2016. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Hemodynamic Effects of Low Dose Spinal Anesthesia for Cesarean Section
- ClinicalTrials.gov ID
- NCT02036697
- Acronym / sponsor ID
- B2013060
- Conditions
- Complications; Cesarean Section, Effects of; Anesthesia, Spinal and Epidural, in Pregnancy, Hemodynamic Instability, Personal Satisfaction
- Keywords
- Cesarean section, spinal anesthesia, low dose spinal, bupivacaine, hemodynamics, blood pressure, cardiac output
- Study type
- Interventional
- Recruitment status
- TerminatedReason stopped: Difficulty with patient recruitment.
- Enrolment
- 30 participants (actual)
- Lead sponsor
- University of ManitobaUniversity, hospital or other
- Study start
- Nov 2013
- Primary completion
- Jun 2014 (actual)
- Study completion
- Dec 2015 (actual)
- First posted
- 15 Jan 2014 (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.
We propose to study the effects on hemodynamics (blood pressure, cardiac output, and central venous pressure) of two doses of bupivacaine for spinal anesthesia during cesarean section: a higher dose of 12 mg to a lower dose of 4.5 mg. We will examine recovery times, incidence of hypotension, and compare pain control and maternal satisfaction during and after cesarean section.
We hypothesize that low dose bupivacaine spinal anesthesia will provide equivalent anesthesia for cesarean section compared to conventional dose bupivacaine, with less hypotension, faster recovery time, and enhanced maternal satisfaction. Maternal satisfaction will be assessed by self-reported pain scores, incidence of nausea and vomiting, shivering, and ability to interact with baby in the OR.
Detailed description
Hypothesis
It is hypothesized that low dose spinal anesthesia can provide equivalent anesthesia for cesarean section as higher conventional dose spinal anesthesia, with less hypotension, faster recovery and enhanced maternal satisfaction.
Patient Population
Adult females having elective, repeat cesarean sections who have given informed consent.
Exclusion Criteria
- Contraindications to dural puncture
- BMI >40
- Elective C/S presenting in labour or with rupture of membranes
- Placenta previa or accrete
Methodology
Patients will be screened in the antenatal clinic at Women's Hospital, Health Sciences Centre (HSC), Winnipeg during one of their regularly scheduled visits. If patients are scheduled at another antenatal clinic in the city, we will ask the obstetrician to briefly mention the study to potential study patients, and if they are interested give them the consent form to take home and read. We will then phone patients, obtain verbal consent and discuss any questions they may have. On the morning of their procedure we will obtain written consent, and answer any additional questions they may have. Alternatively, patients will be approached by their obstetrician in clinic, and if interested will be given the option to go to the Pre-Anesthesia Clinic at HSC where a member of our study team will discuss the study with them and obtain written consent.
Potential patients will be provided with information regarding the study and consent will be obtained prior to their enrollment in the study. Forty patients will be randomized into two groups: 1. Conventional dose spinal anesthesia 2. Low dose spinal anesthesia. Randomization will occur via sealed envelope prior to their scheduled cesarean section. The patient will be blinded to the randomization.
All women will have standard monitors. In addition, a radial arterial line will be inserted for continuous blood pressure measurement and cardiac output measurements using the FloTrac sensor and Vigileo monitor(cardiac output monitor using arterial waveform analysis, Edwards Life Sciences). All women will receive a preload of 500ml of Ringers Lactate solution intravenously.
The conventional dose control group will receive a spinal anesthetic consisting of hyperbaric bupivacaine 1.2cc (9mg) with fentanyl 15mg and preservative free morphine 150mcg. The patient will be in the sitting position for the dural puncture and then positioned supine, in the left lateral tilt position after the anesthetic solution has been given. Once block height has been established the patient will be placed in 20-30 degrees trendelenberg for the cesarean section.
The low-dose spinal group will receive a spinal anesthetic consisting of hyperbaric bupivacaine 4.5mg with fentanyl 15mg and preservative free morphine 150mcg. The patient will be positioned on her side, right side down and head down 20-30 degrees for the dural puncture and then positioned supine in the left lateral tilt position after the anesthetic solution has been given. The OR table will be kept in 20-30 degrees head down for the cesarean section.
Blood pressure will be monitored continuously. Cardiac output measurement will be done immediately prior to administering the spinal and immediately after positioning in a left lateral tilt position and then every five minutes until the end of the operation.
All women will be instructed in the use of a patient controlled analgesia (PCA) remifentanil infusion which they can use during the cesarean section if they experience any discomfort. If this is not adequate, 60-70% nitrous oxide will be attempted. If adequate pain control cannot be established and the cesarean section is not near completion, conversion to a general anesthetic will be the next step. All women will receive rectal naproxen at the conclusion of the surgery unless there is a contraindication or bleeding is a concern. All women will receive prophylactic ondansetron intraoperatively unless there is a contraindication.
Decreases in mean blood pressure greater than 20% from baseline or less than 90 mm Hg will be defined as hypotension and will be treated with incremental doses of phenylephrine (50-100mcg IV) or ephedrine (5mg) if maternal heart rate is less than 60 bpm. A 500cc lactated ringers bolus will be co-administered with initiation of the spinal anesthetic. Further fluids will be administered with a goal of approximately 1-1.5 liters intraoperatively. Each patient will in addition receive 20 units Oxytocin in 500cc saline. Additional fluid or uterotonics will be given as necessary for bleeding or hypotension and will be taken into account at the end.
Levels of sensory and motor blockade will be recorded just prior to skin prep, following arrival in recovery room and then every 30 minutes thereafter. Sensory block will be monitored by dermatome level at which there is a loss of sensation to ice. Motor blockade will be checked using the modified Bromage score (0 = no impairment, 1 = unable to raise extended legs but able to move knees and ankles, 2 = unable to raise extended legs or to flex knees but able to move feet, 3 = unable to flex ankles, knees or hips).
Maternal satisfaction will be assessed as self reported pain scores, nausea/vomiting, shivering, ability to interact with baby in the OR.
Outcome measures will include the following
- Hemodynamics (BP, heart rate (HR), Cardiac Index)
- Time to completion of spinal anesthetic (from skin puncture to positioning in the left lateral tilt position)
- Surgical time (skin incision to skin closure)
- Total remifentanil administration during the procedure
- Total phenylephrine administration during the procedure
- Administration of any other sedatives/anti-emetics
- Fetal cord blood gases (arterial and venous) and Apgar scores
- Maternal satisfaction scores
- Bilateral sensory block levels Bromage scores on arrival to PACU and every 30 minutes until the patient is discharge ready
- Time to being discharge ready from PACU
- Complications (difficult spinal, PDPH)
Outcome 1 to 6 will be recorded intraoperatively (average time 90 to 120 minutes). Outcomes 6 to 10 will be recorded in the post anesthesia care unit (PACU)(average stay 4 to 6 hours). Outcome 11 will be recorded for the duration of the patient's hospital stay.
Patients will be followed for the duration of their hospital stay (estimated three days).
Statistical Analysis
Statistical analysis will be done by the Biostatistical Consulting Unit of the University of Manitoba. It will consist of analysis of variance for repeated measures for continuous variables, student's T-test and Chi square analysis for non-parametric variables. P<0.05 will be considered statistically significant.
We propose to study 20 patients in each group.
Study design
- Allocation
- Randomised
- Intervention model
- Single group
- Masking
- Double blind (participant, outcomes assessor)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Low Dose Spinal | Experimental | Drug: Bupivacaine 4.5, Drug: Morphine, Drug: FentanylHyperbaric bupivacaine 4.5mg with fentanyl 15mcg and preservative free morphine 150mcg. The patient will be positioned right side down and head down 20-30 degrees for the dural puncture and then positioned supine in the left lateral tilt position after the anesthetic solution has been given. The OR table will be kept in 20-30 degrees head down for the cesarean section. |
| Control Spinal Group | Active comparator | Drug: Bupivacaine 9, Drug: Morphine, Drug: FentanylHyperbaric bupivacaine 1.2cc (9mg) with fentanyl 15mcg and preservative free morphine 150mcg. The patient will be in the sitting position for the dural puncture and then positioned supine, in the left lateral tilt position after the anesthetic solution has been given. Once block height has been established the patient will be placed in 20-30 degrees trendelenberg for the cesarean section. |
Who may qualify
- Ages
- 18 to 40 years
- Sex
- Female only
- Healthy volunteers
- Not accepted
- Age groups
- Adult
Key inclusion criteria (1 listed)
- Adult females having elective, repeat cesarean sections who have given informed consent.
Key exclusion criteria (4 listed)
- • Contraindications to dural puncture
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 4.5Bupivacaine hyperbaric, 4.5 mg | Drug | Low Dose Spinal |
| Bupivacaine 9Bupivacaine hyperbaric, 9 mg | Drug | Control Spinal Group |
| Morphinemorphine 150 mcg. | Drug | Control Spinal Group, Low Dose Spinal |
| Fentanyl15 mcg | Drug | Control Spinal Group, Low Dose Spinal |
Primary outcome
Recovery room length of stay
Time frame: Current recovery room average length of stay is 4 hours
The primary endpoint is the expected reduction in the Recovery Room length of stay. Based on a predicted 50-100% reduction in length of stay, alpha 0.05, power of 80%, and given an anticipated drop-out rate of 10%, a sample size of n = 20 study patients per group is required.
1 secondary outcome
Hemodynamics
Time frame: Average duration of surgery is 100 minutes
Results and safety
The study was stopped early (reason given: Difficulty with patient recruitment.). Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 8 Nov 2016.
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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.
Stephen E Kowalski, MD principal investigator
University of Manitoba
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 4.5, Bupivacaine 9 and Morphine in people with Complications; Cesarean Section and Effects of; Anesthesia, Spinal and Epidural, in Pregnancy, run by University of Manitoba 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 1 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: stopped early, as of the sponsor's last update on 8 Nov 2016. 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 was stopped early (reason given: Difficulty with patient recruitment.). Results are not available in the source record.
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?
Recovery room length of stay (time frame: Current recovery room average length of stay is 4 hours). 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 8 Nov 2016.