Intravenous Methadone Versus Intrathecal Morphine for Analgesia Following Cesarean Delivery

Phase 4

Recruiting

• Conditions: Cesarean Delivery
• Interventions: Drug: Intravenous line (IV) Methadone; Drug: Intrathecal Morphine

• Registration Number: NCT06826742
• Lead Sponsor: Mayo Clinic

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.

Detailed Description

Not available

Study Timeline

• Status Verified: 2025-02
• Study First Submitted: 2025-02-10
• Study First Submitted QC: 2025-02-10
• Study Start: 2025-02-12
• Study First Posted: 2025-02-14
• Last Update Submitted: 2025-02-28
• Last Update Posted: 2025-03-03
• Primary Completion: 2025-09-30
• Study Completion: 2025-11-07

Recruitment & Eligibility

• Status: RECRUITING
• Sex: Female
• Target Recruitment: 50

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 & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
Spinal Anesthesia with Intravenous Methadone	Intravenous line (IV) Methadone	Subjects will receive spinal anesthesia (intrathecal bupivacaine with fentanyl) with intravenous methadone
Spinal Anesthesia with Intrathecal Morphine	Intrathecal Morphine	Subjects will receive spinal anesthesia (intrathecal bupivacaine with fentanyl) with intrathecal morphine

Primary Outcome Measures

Name	Time	Method
Total opioid consumption	24 hours post-delivery, 48 hours post-delivery	Total opioid consumption of either intrathecal opiate or intravenous methadone at 24-48 hours after delivery.

Secondary Outcome Measures

Name	Time	Method
Obstetric Quality of Recovery-10 (ObsQoR-10) Scoring Tool	24 hours, 48 hours, 7 days	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.
Numeric Rating Scale (NRS) pain score at rest	12 hours, 24 hours, 36 hours, 48 hours, 7 days	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".
Numeric Rating Scale (NRS) for movement-evoked pain	12 hours, 24 hours, 36 hours, 48 hours, 7 days	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".
Numeric Rating Scale (NRS) for pain in previous 24 hours	12 hours, 24 hours, 36 hours, 48 hours, 7 days	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".
Pruritus	12 hours, 24 hours, 36 hours, 48 hours	The severity of pruritus post spinal administration will be patient-reported on a 4-point Likert scale where 0 = none and 3 = severe.
Richmond Agitation Sedation Scale (RASS)	12 hours, 24 hours, 36 hours, 48 hours	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.

Trial Locations

Locations (1)

Mayo Clinic in Rochester; 🇺🇸 Rochester, Minnesota, United States