Intravenous Methadone Versus Intrathecal Morphine for Analgesia Following Cesarean Delivery

Mayo Clinic

Status and phase: Completed; Phase 4

Conditions: Cesarean Delivery

Treatments: Drug: Intravenous line (IV) Methadone; Drug: Intrathecal Morphine

Study type: Interventional

Funder types: Other

Identifiers

NCT06826742

24-000215

Details and patient eligibility

About

The purpose of this study is to determine if there is a difference in opioid requirements at 0-48 hours after scheduled cesarean delivery in patients receiving 150 mcg intrathecal morphine compared to 0.2 mg/kg (maximum 20 mg) intravenous methadone.

Enrollment: 30 patients

Sex: Female

Ages: 18+ years old

Volunteers: Accepts Healthy Volunteers

Inclusion criteria

• English-speaking
• Age over 18 years old
• Scheduled cesarean delivery

Exclusion criteria

• Any contraindication to the administration of a spinal technique for anesthesia
• 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

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: Triple Blind

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30 participants in 2 patient groups

Spinal Anesthesia with Intravenous Methadone

Experimental group

Description:

Subjects will receive spinal anesthesia (intrathecal bupivacaine with fentanyl) with intravenous methadone

Treatment:

Drug: Intravenous line (IV) Methadone

Spinal Anesthesia with Intrathecal Morphine

Active Comparator group

Description:

Subjects will receive spinal anesthesia (intrathecal bupivacaine with fentanyl) with intrathecal morphine

Treatment:

Drug: Intrathecal Morphine