Intravenous Methadone Versus Intrathecal Morphine for Analgesia Following Cesarean Delivery
NCT ID: NCT06826742
Last Updated: 2026-01-05
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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COMPLETED
PHASE4
30 participants
INTERVENTIONAL
2025-02-12
2025-09-23
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
TRIPLE
Study Groups
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Spinal Anesthesia with Intravenous Methadone
Subjects will receive spinal anesthesia (intrathecal bupivacaine with fentanyl) with intravenous methadone
Intravenous line (IV) Methadone
Subjects will receive standardized spinal anesthesia without intrathecal morphine (intrathecal 1.6-2 mL 0.75% bupivacaine + dextrose, 15 mcg fentanyl) and intravenous methadone (0.2mg/kg total body weight up to max dose of 20 mg, with saline added to make total volume 2 mL)
The Intravenous line (IV) methadone will be administered after cord clamping and administration of uterotonics with the dose of medication divided into 4 equal aliquots each administered 5 minutes apart.
Spinal Anesthesia with Intrathecal Morphine
Subjects will receive spinal anesthesia (intrathecal bupivacaine with fentanyl) with intrathecal morphine
Intrathecal Morphine
Subjects will receive standardized spinal anesthesia with intrathecal morphine 150 micrograms and no methadone (2cc dose of IV normal saline)
The Intravenous line (IV) saline will be administered after cord clamping and administration of uterotonics with the dose of medication divided into 4 equal aliquots each administered 5 minutes apart.
Interventions
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Intravenous line (IV) Methadone
Subjects will receive standardized spinal anesthesia without intrathecal morphine (intrathecal 1.6-2 mL 0.75% bupivacaine + dextrose, 15 mcg fentanyl) and intravenous methadone (0.2mg/kg total body weight up to max dose of 20 mg, with saline added to make total volume 2 mL)
The Intravenous line (IV) methadone will be administered after cord clamping and administration of uterotonics with the dose of medication divided into 4 equal aliquots each administered 5 minutes apart.
Intrathecal Morphine
Subjects will receive standardized spinal anesthesia with intrathecal morphine 150 micrograms and no methadone (2cc dose of IV normal saline)
The Intravenous line (IV) saline will be administered after cord clamping and administration of uterotonics with the dose of medication divided into 4 equal aliquots each administered 5 minutes apart.
Eligibility Criteria
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Inclusion Criteria
* Age over 18 years old
* Scheduled cesarean delivery
Exclusion Criteria
* History of intolerance or adverse reaction to opioid medications
* History of chronic pain, opioid use \>30 OME/day, or substance use disorder
* History of obstructive sleep apnea, chronic obstructive pulmonary disease, or respiratory compromise (SpO2 \<92% on room air, or has a pre-existing oxygen requirement)
* History of liver or kidney failure
* Diagnosis of pre-eclampsia with current pregnancy
* Depression requiring more than one medication
* Planned use of CSE technique
* BMI \>50.0 kg/m2
* ASA status IV, V
* No prior history of an ECG demonstrating QTc \> 440ms
* Surgical complication requiring conversion to general anesthesia
18 Years
FEMALE
Yes
Sponsors
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Mayo Clinic
OTHER
Responsible Party
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Emily E. Sharpe, M.D.
Principal Investigator
Principal Investigators
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Emily E Sharpe, M.D.
Role: PRINCIPAL_INVESTIGATOR
Mayo Clinic
Locations
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Mayo Clinic in Rochester
Rochester, Minnesota, United States
Countries
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Related Links
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Mayo Clinic Clinical Trials
Other Identifiers
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24-000215
Identifier Type: -
Identifier Source: org_study_id
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