Intravenous Methadone Versus Intrathecal Morphine for Analgesia Following Cesarean Delivery

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

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.

Study Overview

• Status: Completed
• Conditions: Cesarean Delivery
• Intervention / Treatment: Drug: Intravenous line (IV) Methadone; Drug: Intrathecal Morphine

• Study Type: Interventional
• Enrollment (Actual): 30
• Phase: Phase 4

Contacts and Locations

Study Locations

• United States
  • Minnesota
    • Rochester, Minnesota, United States, 55905
      • Mayo Clinic in Rochester

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: Adult; Older Adult
• Accepts Healthy Volunteers: Yes

Description

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

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Treatment
• Allocation: Randomized
• Interventional Model: Parallel Assignment
• Masking: Triple

Number of Arms

2

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Experimental: Spinal Anesthesia with Intravenous Methadone; Subjects will receive spinal anesthesia (intrathecal bupivacaine with fentanyl) with intravenous methadone	Drug: 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.
Active Comparator: Spinal Anesthesia with Intrathecal Morphine; Subjects will receive spinal anesthesia (intrathecal bupivacaine with fentanyl) with intrathecal morphine	Drug: 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.

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Total opioid consumption	Total opioid consumption of either intrathecal opiate or intravenous methadone at 24-48 hours after delivery.	24 hours post-delivery, 48 hours post-delivery

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Numeric Rating Scale (NRS) pain score at rest	A Numeric Rating Scale (NRS) for pain is a patient-reported item regarding the level of pain experienced at rest and is measured on a Likert scale from 0 to 10, where 0 represents "no pain" and 10 represents "the worst pain imaginable".	12 hours, 24 hours, 36 hours, 48 hours, 7 days
Numeric Rating Scale (NRS) for movement-evoked pain	A Numeric Rating Scale (NRS) score for movement-evoked pain is a patient-reported item regarding the level of pain experienced with provoking maneuvers such as cough, inspiration/expiration, sitting up, knee flexion, hip flexion, rolling over in bed, and walking. The NRS is measured on a Likert scale from 0 to 10, where 0 represents "no pain" and 10 represents "the worst pain imaginable".	12 hours, 24 hours, 36 hours, 48 hours, 7 days
Numeric Rating Scale (NRS) for pain in previous 24 hours	A Numeric Rating Scale (NRS) score for highest level of pain is a patient-reported item regarding the level of pain experienced in the last 24 hours. The NRS is measured on a Likert scale from 0 to 10, where 0 represents "no pain" and 10 represents "the worst pain imaginable".	12 hours, 24 hours, 36 hours, 48 hours, 7 days
Pruritus	The severity of pruritus post spinal administration will be patient-reported on a 4-point Likert scale where 0 = none and 3 = severe.	12 hours, 24 hours, 36 hours, 48 hours
Richmond Agitation Sedation Scale (RASS)	The Richmond Agitation Sedation Scale (RASS) will be used to assess the level of alertness and agitated behavior in patients. The patient's level of consciousness and sedation are rated by care provider, ranging from a combative state (+4) to an unarousable state (-5), with a "calm and alert" score at 0.	12 hours, 24 hours, 36 hours, 48 hours
Obstetric Quality of Recovery-10 (ObsQoR-10) Scoring Tool	The Obstetric Quality of Recovery-10 (ObsQoR-10), is a patient-reported 10-item questionnaire used to assess quality of recovery following spinal administration of pain medication. Patients rate each recovery item on a scale of 0 to 10, with 0 = worst possible recovery and 10 = best possible recovery. Total score ranges from 0-100 with higher scores indicating a better recovery after childbirth.	24 hours, 48 hours, 7 days

Collaborators and Investigators

• Sponsor: Mayo Clinic
• Investigators: Principal Investigator: Emily E Sharpe, M.D., Mayo Clinic

Publications and helpful links

Helpful Links

• Mayo Clinic Clinical Trials

Study record dates

Study Major Dates

• Study Start (Actual): February 12, 2025
• Primary Completion (Actual): September 14, 2025
• Study Completion (Actual): September 23, 2025

Study Registration Dates

• First Submitted: February 10, 2025
• First Submitted That Met QC Criteria: February 10, 2025
• First Posted (Actual): February 14, 2025

Study Record Updates

• Last Update Posted (Actual): January 5, 2026
• Last Update Submitted That Met QC Criteria: December 31, 2025
• Last Verified: December 1, 2025

More Information

Terms related to this study

• Keywords: morphine; methadone; cesarean; intrathecal
• Additional Relevant MeSH Terms: Organic Chemicals; Ketones; Methadone
• Other Study ID Numbers: 24-000215

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: NO

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: Yes
• Studies a U.S. FDA-regulated device product: No
• product manufactured in and exported from the U.S.: No