HypotensionNCT00990574
A Study Comparing Two Spinal Techniques for for Cesarean Delivery Anesthesia
A study testing Wiley Spinal Catheter and Spinal Anesthesia Group (SAG) in people with Hypotension and Headache, run by Stanford University at 1 site in United States.
Trial summary
The purpose of this study is to compare single shot versus sequential bolus spinal technique via a catheter in patients undergoing Cesarean Section. We aim to determine which technique results in less blood pressure reduction and subsequent vasopressor use. Read more about this study
- Who is it for?
- Ages 18 to 45 years, women only
- Conditions the study is for
- Hypotension, Headache
- What is being tested?
- Wiley Spinal Catheter and Spinal Anesthesia Group (SAG)
- Type of treatment
- Medical device
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 0 participants
- Where
- 1 siteUnited States
- Study dates
- Oct 2009to Apr 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 45 years
- Women only
- No healthy volunteers
- Adult
Who may be able to join
- American Society of Anesthesiologists (ASA) Class I, II patients
- 18-45 year of age
- Uncomplicated singleton, term pregnancy
- Scheduled for Cesarean section
Who cannot join
- ASA class 3 and above
- Morbid obesity (BMI>40 kg/m2)
- Postpartum tubal ligation after cesarean
- Hypersensitivity and/or prior reaction to opioids
- Ineffective spinal
- Conversion to general anesthesia
Show all 10Show fewer
- Multiple gestation pregnancy
- Emergency C-section
- Contraindication to regional anesthesia
- History of chronic opioid use
Trial locations and contacts
1 site in 1 country.
United States1 site
Stanford University School of Medicine
Stanford, California, 94305
About this study
Official title: Spinal Anesthesia for Cesarean Delivery: The Wiley Spinal Catheter Intermittent Bolus Technique Versus Single Shot Spinal Anesthesia
The purpose of this study is to compare single shot versus sequential bolus spinal technique via a catheter in patients undergoing Cesarean Section. We aim to determine which technique results in less blood pressure reduction and subsequent vasopressor use.
Other study endpoints include the incidence of maternal post dural puncture headaches and nausea and vomiting. In addition blood and CSF will be collected to see if biochemical mediators are related to wound hyperalgesia and healing.
Read the detailed description
Following IRB approval, the investigators plan to enroll 60 pregnant women (30 in the spinal anesthesia group (SAG), and 30 patients in the Wiley spinal catheter group (WSCG)) undergoing cesarean delivery. Patients will be randomly assigned to one of these two groups.
Both groups will undergo the standard procedures involved in placement of a spinal anesthetic in the sitting position. The SAG will have their drugs dosed intrathecally as a "single shot" while still in the sitting position. The WSCG will have a Wiley spinal catheter placed, but it will not be dosed until the patient is in the supine position with left uterine displacement. Both groups will be dosed with 12 mg of 0.75% hyperbaric bupivacaine, 10 mcg of fentanyl, and 100 mcg of morphine. While the SAG will receive their total dose as a one time bolus, the WSCG patients will receive the medication in sequential doses.
Blood pressure will be monitored every minute after spinal medication is administered until delivery of the baby. Thereafter, it will be monitored at least every 3 minutes. Any blood pressure below 90, 80 and 70% of baseline will be treated with 50, 100 and 150 mcg of phenylephrine, respectively.
In the WSC group, cerebrospinal fluid (CSF) will be collected prior to intrathecal dosing, and then 1 and 5 hours post-spinal utilizing a three-way stopcock incorporated into the IT catheter.
All CSF samples will be analyzed for various nociceptive and inflammatory biochemical mediators using a multiplex bead array immunoassay plate. Venous blood will be drawn prior to spinal dosing and 5 hours afterwards to measure the same cytokines and biochemical mediators.
Participants will be followed for 2 days post cesarean section to monitor for episodes of a spinal or post dural puncture headache (PDPH). A PDPH is defined as an occipital or frontal headache brought on by the erect posture and relieved when the supine posture is assumed. If the PDPH persists longer than 24 h with the same severity, an epidural blood patch (EBP) will be performed. The decision to perform an EBP will always be made by a staff anesthesiologist. Headaches will be monitored daily for 3 days, then at 1 week. Patients will be treated for their headaches per standard methods by an anesthesiologist not involved in the study.
Postoperative pain will be recorded at rest and sitting at 1, 5, 24, 48h post-cesarean using a VPS 0-10 (0=no pain, 10=worse pain imaginable) measure. The area of secondary hyperalgesia surrounding the wound will be measured at 48hours with a von Frey filament. A color laser Doppler will also be used to assess vascular perfusion of the wound 48 hours after surgery.
- Conditions
- Hypotension, Headache
- Being tested
- Wiley Spinal Catheter, Spinal Anesthesia Group (SAG)
- Medical subject headings
- Hypotension, Headache
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Wiley Spinal CatheterDevice
The WSCG (wiley spinal catheter group) will have a Wiley spinal catheter placed, but it will not be dosed until the patient is in the supine position with left uterine displacement. Participants will receive the medication (12 mg of 0.75% hyperbaric bupivacaine, 10 mcg of fentanyl, and 100 mcg of morphine) in sequential doses.
Spinal Anesthesia Group (SAG)Device
The SAG (spinal anesthesia group) will have their drugs (12 mg of 0.75% hyperbaric bupivacaine, 10 mcg of fentanyl, and 100 mcg of morphine) dosed intrathecally as a "single shot" while still in the sitting position.
| Study group | Role | What they receive |
|---|---|---|
| spinal anesthesia group (SAG) | Active comparator | Participants will undergo the standard procedures involved in placement of a spinal anesthetic in the sitting position. Receives: Device: Spinal Anesthesia Group (SAG) |
| The WSCG (wiley spinal catheter group) | Active comparator | The WSCG (wiley spinal catheter group) will undergo the standard procedures involved in placement of a spinal anesthetic in the sitting position. Receives: Device: Wiley Spinal Catheter |
What is being measured
The primary outcome is the main question the study is designed to answer.
Blood pressure maintenance
Measured: Spinal to End Surgery
Vasopressor use
Measured: Spinal to End Surgery
Secondary outcomes (3)
Post-spinal Headache
Measured: 1 week
Postoperative pain, wound hyperalgesia and perfusion
Measured: 48 h
CSF and blood biochemical nociceptive and inflammatory mediators
Measured: 5 h
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted7 Oct 2009 (estimated)
- Study startOct 2009
- Primary completionApr 2015
- Study completionApr 2015
Why it stopped: device not found to be adequate
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for HypotensionStudies of the same condition, open and under way.
- More trials run by Stanford UniversityThe 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
- Primary purpose
- Prevention
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Double blind
- Who is masked
- Participant, Outcomes assessor
- Enrolment
- 0 participants (actual)
Sponsor and investigators
- Lead sponsor
- Stanford University
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Brendan Carvalho, Stanford University
- Investigators
- Brendan Carvalho, Principal investigator, Stanford University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT00990574
- Sponsor's protocol ID
- SU-10012009-4120
- Other IDs
- 17492
- Status last verified
- Oct 2015
- First submitted
- 5 Oct 2009
- Last updated
- 8 Oct 2015
- Results posted
- No
- Data monitoring committee
- No
Study at a glance
From the registry record, last updated by the sponsor on 8 Oct 2015. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Spinal Anesthesia for Cesarean Delivery: The Wiley Spinal Catheter Intermittent Bolus Technique Versus Single Shot Spinal Anesthesia
- ClinicalTrials.gov ID
- NCT00990574
- Acronym / sponsor ID
- SU-10012009-4120
- Conditions
- Hypotension, Headache
- Study type
- Interventional
- Recruitment status
- WithdrawnReason stopped: device not found to be adequate
- Enrolment
- 0 participants (actual)
- Lead sponsor
- Stanford UniversityUniversity, hospital or other
- Study start
- Oct 2009
- Primary completion
- Apr 2015 (actual)
- Study completion
- Apr 2015 (actual)
- First posted
- 7 Oct 2009 (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 this study is to compare single shot versus sequential bolus spinal technique via a catheter in patients undergoing Cesarean Section. We aim to determine which technique results in less blood pressure reduction and subsequent vasopressor use.
Other study endpoints include the incidence of maternal post dural puncture headaches and nausea and vomiting. In addition blood and CSF will be collected to see if biochemical mediators are related to wound hyperalgesia and healing.
Detailed description
Following IRB approval, the investigators plan to enroll 60 pregnant women (30 in the spinal anesthesia group (SAG), and 30 patients in the Wiley spinal catheter group (WSCG)) undergoing cesarean delivery. Patients will be randomly assigned to one of these two groups.
Both groups will undergo the standard procedures involved in placement of a spinal anesthetic in the sitting position. The SAG will have their drugs dosed intrathecally as a "single shot" while still in the sitting position. The WSCG will have a Wiley spinal catheter placed, but it will not be dosed until the patient is in the supine position with left uterine displacement. Both groups will be dosed with 12 mg of 0.75% hyperbaric bupivacaine, 10 mcg of fentanyl, and 100 mcg of morphine. While the SAG will receive their total dose as a one time bolus, the WSCG patients will receive the medication in sequential doses.
Blood pressure will be monitored every minute after spinal medication is administered until delivery of the baby. Thereafter, it will be monitored at least every 3 minutes. Any blood pressure below 90, 80 and 70% of baseline will be treated with 50, 100 and 150 mcg of phenylephrine, respectively.
In the WSC group, cerebrospinal fluid (CSF) will be collected prior to intrathecal dosing, and then 1 and 5 hours post-spinal utilizing a three-way stopcock incorporated into the IT catheter.
All CSF samples will be analyzed for various nociceptive and inflammatory biochemical mediators using a multiplex bead array immunoassay plate. Venous blood will be drawn prior to spinal dosing and 5 hours afterwards to measure the same cytokines and biochemical mediators.
Participants will be followed for 2 days post cesarean section to monitor for episodes of a spinal or post dural puncture headache (PDPH). A PDPH is defined as an occipital or frontal headache brought on by the erect posture and relieved when the supine posture is assumed. If the PDPH persists longer than 24 h with the same severity, an epidural blood patch (EBP) will be performed. The decision to perform an EBP will always be made by a staff anesthesiologist. Headaches will be monitored daily for 3 days, then at 1 week. Patients will be treated for their headaches per standard methods by an anesthesiologist not involved in the study.
Postoperative pain will be recorded at rest and sitting at 1, 5, 24, 48h post-cesarean using a VPS 0-10 (0=no pain, 10=worse pain imaginable) measure. The area of secondary hyperalgesia surrounding the wound will be measured at 48hours with a von Frey filament. A color laser Doppler will also be used to assess vascular perfusion of the wound 48 hours after surgery.
Study design
- Primary purpose
- Prevention
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Double blind (participant, outcomes assessor)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| spinal anesthesia group (SAG) | Active comparator | Device: Spinal Anesthesia Group (SAG)Participants will undergo the standard procedures involved in placement of a spinal anesthetic in the sitting position. |
| The WSCG (wiley spinal catheter group) | Active comparator | Device: Wiley Spinal CatheterThe WSCG (wiley spinal catheter group) will undergo the standard procedures involved in placement of a spinal anesthetic in the sitting position. |
Who may qualify
- Ages
- 18 to 45 years
- Sex
- Female only
- Healthy volunteers
- Not accepted
- Age groups
- Adult
Key inclusion criteria (4 listed)
- American Society of Anesthesiologists (ASA) Class I, II patients
- 18-45 year of age
- Uncomplicated singleton, term pregnancy
- Scheduled for Cesarean section
Key exclusion criteria (10 listed)
- ASA class 3 and above
- Morbid obesity (BMI>40 kg/m2)
- Postpartum tubal ligation after cesarean
- Hypersensitivity and/or prior reaction to opioids
- Ineffective spinal
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 |
|---|---|---|
| Wiley Spinal CatheterThe WSCG (wiley spinal catheter group) will have a Wiley spinal catheter placed, but it will not be dosed until the patient is in the supine position with left uterine displacement. Participants will receive the medication (12 mg of 0.75% hyperbaric bupivacaine, 10 mcg of fentanyl, and 100 mcg of morphine) in sequential doses. | Device | The WSCG (wiley spinal catheter group) |
| Spinal Anesthesia Group (SAG)The SAG (spinal anesthesia group) will have their drugs (12 mg of 0.75% hyperbaric bupivacaine, 10 mcg of fentanyl, and 100 mcg of morphine) dosed intrathecally as a "single shot" while still in the sitting position. | Device | spinal anesthesia group (SAG) |
Primary outcome
Blood pressure maintenance
Time frame: Spinal to End Surgery
Vasopressor use
Time frame: Spinal to End Surgery
3 secondary outcomes
Post-spinal Headache
Time frame: 1 week
Postoperative pain, wound hyperalgesia and perfusion
Time frame: 48 h
CSF and blood biochemical nociceptive and inflammatory mediators
Time frame: 5 h
Results and safety
The study was withdrawn before enrolling participants, so there are no results.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 8 Oct 2015.
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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.
Brendan Carvalho principal investigator
Stanford University
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Wiley Spinal Catheter and Spinal Anesthesia Group (SAG) in people with Hypotension and Headache, run by Stanford University at 1 site in United States.
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 4 inclusion and 10 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: withdrawn, as of the sponsor's last update on 8 Oct 2015. 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 United States. 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 withdrawn before enrolling participants, so there are no results.
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?
Blood pressure maintenance (time frame: Spinal to End Surgery). 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 8 Oct 2015.