Intravenous Methadone Versus Intrathecal Morphine for Analgesia Following Cesarean Delivery

NCT06826742 | Completed Phase 4 FDA Drug

• 1 other identifier: 24-000215
• Study Type: interventional
• Target: 30
• Locations: 1 country
• Sites: 1

Brief 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.

Conditions

Cesarean Delivery

Keywords

methadone; morphine; intrathecal; cesarean

Outcome Measures

Primary Outcomes (1)

• 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 Outcomes (6)

• Obstetric Quality of Recovery-10 (ObsQoR-10) Scoring Tool

  24 hours, 48 hours, 7 days

• Numeric Rating Scale (NRS) pain score at rest

  12 hours, 24 hours, 36 hours, 48 hours, 7 days

• Numeric Rating Scale (NRS) for movement-evoked pain

  12 hours, 24 hours, 36 hours, 48 hours, 7 days

• Numeric Rating Scale (NRS) for pain in previous 24 hours

  12 hours, 24 hours, 36 hours, 48 hours, 7 days

• Pruritus

  12 hours, 24 hours, 36 hours, 48 hours

Study Arms (2)

Spinal Anesthesia with Intravenous Methadone

EXPERIMENTAL

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

Drug: Intravenous line (IV) Methadone

Spinal Anesthesia with Intrathecal Morphine

ACTIVE COMPARATOR

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

Drug: Intrathecal Morphine

Interventions

Intravenous line (IV) Methadone DRUG

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.

Spinal Anesthesia with Intravenous Methadone

Intrathecal Morphine DRUG

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.

Spinal Anesthesia with Intrathecal Morphine

Eligibility Criteria

• Age: 18 Years+
• Sex: female
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

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

You may not qualify if:

• 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

Sponsors & Collaborators

• Mayo Clinic: lead

Study Sites (1)

Mayo Clinic in Rochester

Rochester, Minnesota, 55905, United States

Location

Related Links

• Mayo Clinic Clinical Trials

MeSH Terms

Interventions

Methadone

Intervention Hierarchy (Ancestors)

Ketones; Organic Chemicals

Study Officials

• Emily E Sharpe, M.D.

  Mayo Clinic

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: phase 4
• Allocation: RANDOMIZED
• Masking: TRIPLE
• Who Masked: PARTICIPANT, INVESTIGATOR, OUTCOMES ASSESSOR
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Principal Investigator

Study Record Dates

• First Submitted: February 10, 2025
• First Posted: February 14, 2025
• Study Start: February 12, 2025
• Primary Completion: September 14, 2025
• Study Completion: September 23, 2025
• Last Updated: January 5, 2026

Record last verified: 2025-12

Data Sharing

• IPD Sharing: Will not share

Locations

US (1)