Intrathecal Morphine vs. Intrathecal Morphine and Regional Anesthesia After Cesarean Section.
NCT ID: NCT06114121
Last Updated: 2024-09-19
Study Results
The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.
Basic Information
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WITHDRAWN
PHASE4
INTERVENTIONAL
2024-07-10
2024-09-10
Brief Summary
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Detailed Description
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Conditions
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Study Design
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RANDOMIZED
PARALLEL
TREATMENT
NONE
Study Groups
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erector spinae plane block
participants will be in this group for up to 9 months and receive erector spinae plane (ESP) block
erector spinae plane block (ESP)
nerve block for abdominal pain. administered once immediately prior to spinal anesthetic standard of care.
Duramorph
100 micrograms (mcg) of morphine administered in the spinal medications one time.
Ropivacaine
Ropivacaine 0.5% between 20-40 milliliters will be administered once in the ESP block (in the spine) depending on patient weight to keep under the maximum dose.
Bupivacaine Injection
Bupivacaine 0.75% 1.4-1.7 milliliters (10-12 milligrams) spinal medication. administered one time.
standard of care
participants in this group will receive the standard of care treatment and will be in this group for up to 9 months.
Duramorph
100 micrograms (mcg) of morphine administered in the spinal medications one time.
Ropivacaine
Ropivacaine 0.5% between 20-40 milliliters will be administered once in the ESP block (in the spine) depending on patient weight to keep under the maximum dose.
Bupivacaine Injection
Bupivacaine 0.75% 1.4-1.7 milliliters (10-12 milligrams) spinal medication. administered one time.
Interventions
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erector spinae plane block (ESP)
nerve block for abdominal pain. administered once immediately prior to spinal anesthetic standard of care.
Duramorph
100 micrograms (mcg) of morphine administered in the spinal medications one time.
Ropivacaine
Ropivacaine 0.5% between 20-40 milliliters will be administered once in the ESP block (in the spine) depending on patient weight to keep under the maximum dose.
Bupivacaine Injection
Bupivacaine 0.75% 1.4-1.7 milliliters (10-12 milligrams) spinal medication. administered one time.
Eligibility Criteria
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Inclusion Criteria
* BMI\<35
Exclusion Criteria
* BMI\>35
* Individuals \<18 years of age at time of admission
* Individuals taking anticoagulant medications
* Significant co-morbid disease of pregnancy (including: gestational diabetes and significant abnormal placentation)
* Pre-existing chronic pain or pain disorder diagnosis
* Conversion from neuraxial to general anesthesia
* Prisoners
18 Years
45 Years
FEMALE
No
Sponsors
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University of Miami
OTHER
Responsible Party
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Reine Zbeidy
Associate Professor of Clinical Anesthesiology
Principal Investigators
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Reine Zbeidy, MD
Role: PRINCIPAL_INVESTIGATOR
University of Miami
Other Identifiers
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20230857
Identifier Type: -
Identifier Source: org_study_id
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