COMPLETED

Intravenous Methadone Versus Intrathecal Morphine for Analgesia Following Cesarean Delivery

Conditions

Cesarean Delivery methadone morphine intrathecal cesarean

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Study Overview

This clinical trial focuses on testing the efficacy of different digital interventions to promote re-engagement in cancer-related long-term follow-up care for adolescent and young adult (AYA) survivors of childhood cancer.

Description

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.

Official Title

Intravenous Methadone Versus Intrathecal Morphine for Analgesia Following Cesarean Delivery: a Randomized Clinical Trial

Quick Facts

Study Start:2025-02-12

Study Completion:2025-09-23

Study Type:Not specified

Phase:Not Applicable

Enrollment:Not specified

Status:COMPLETED

Study ID

NCT06826742

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Ages Eligible for Study:18 Years

Sexes Eligible for Study:FEMALE

Accepts Healthy Volunteers:Yes

Standard Ages:ADULT, OLDER_ADULT

Inclusion Criteria	Exclusion Criteria
* English-speaking * Age over 18 years old * Scheduled cesarean delivery	* 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

Inclusion Criteria

Exclusion Criteria

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

* 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

Contacts and Locations

Principal Investigator

Emily E Sharpe, M.D.

PRINCIPAL_INVESTIGATOR

Mayo Clinic

Study Locations (Sites)

Mayo Clinic in Rochester

Rochester, Minnesota, 55905

United States

Collaborators and Investigators

Sponsor: Mayo Clinic

Emily E Sharpe, M.D., PRINCIPAL_INVESTIGATOR, Mayo Clinic

Study Record Dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Registration Dates

Study Start Date2025-02-12

Study Completion Date2025-09-23

Study Record Updates

Study Start Date2025-02-12

Study Completion Date2025-09-23

Terms related to this study

Keywords Provided by Researchers

methadone
morphine
intrathecal
cesarean

Additional Relevant MeSH Terms

Cesarean Delivery