Intravenous Methadone Versus Intrathecal Morphine for Analgesia Following Cesarean Delivery

Last updated: February 28, 2025
Sponsor: Mayo Clinic
Overall Status: Active - Recruiting

Phase

4

Condition

Labor/delivery

Treatment

Intrathecal Morphine

Intravenous line (IV) Methadone

Clinical Study ID

NCT06826742
24-000215
  • Ages > 18
  • Female
  • Accepts Healthy Volunteers

Study Summary

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.

Eligibility Criteria

Inclusion

Inclusion Criteria:

  • English-speaking

  • Age over 18 years old

  • Scheduled cesarean delivery

Exclusion

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, orrespiratory compromise (SpO2 <92% on room air, or has a pre-existing oxygenrequirement)

  • 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

Study Design

Total Participants: 50
Treatment Group(s): 2
Primary Treatment: Intrathecal Morphine
Phase: 4
Study Start date:
February 12, 2025
Estimated Completion Date:
November 07, 2025

Connect with a study center

  • Mayo Clinic in Rochester

    Rochester, Minnesota 55905
    United States

    Active - Recruiting

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