Intravenous Methadone versus Intrathecal Morphine for Analgesia Following Cesarean Delivery

Overview

About this study

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

Participation eligibility

Participant eligibility includes age, gender, type and stage of disease, and previous treatments or health concerns. Guidelines differ from study to study, and identify who can or cannot participate. There is no guarantee that every individual who qualifies and wants to participate in a trial will be enrolled. Contact the study team to discuss study eligibility and potential participation.

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 or need for supplemental analgesia >100mcg IV fentanyl; >2 mg of IV midazolam; any amount of IV ketamine, propofol, morphine, hydromorphone, remifentanil, or sufentanil; and/or inhaled nitrous oxide. 

Note: Other protocol defined Inclusion/Exclusion Criteria may apply.

Eligibility last updated 11/04/2024. Questions regarding updates should be directed to the study team contact.

 

Participating Mayo Clinic locations

Study statuses change often. Please contact the study team for the most up-to-date information regarding possible participation.

Mayo Clinic Location Status Contact

Rochester, Minn.

Mayo Clinic principal investigator

Emily Sharpe, M.D.

Contact us for the latest status

Contact information:

Emily Sharpe M.D.

(507) 284-9839

Sharpe.Emily@mayo.edu

More information

Publications

Publications are currently not available