NCT06826742CompletedPhase 4
Intravenous Methadone Versus Intrathecal Morphine for Analgesia Following Cesarean Delivery: a Randomized Clinical Trial
Conditions
Interventions
Drugs
Trial Snapshot
- Phase
- Phase 4
- Status
- Completed
- Sponsor
- Mayo Clinic
- Enrollment
- 30
- Locations
- 1
- Primary Endpoint
- Total opioid consumption
Study Overview
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.
Study Design
- Study Type
- Interventional
- Allocation
- Randomized
- Intervention Model
- Parallel
- Primary Purpose
- Treatment
- Masking
- Triple (Participant, Investigator, Outcomes Assessor)
Eligibility Criteria
- Ages
- 18 Years to — (Adult, Older Adult)
- Sex
- Female
- Accepts Healthy Volunteers
- Yes
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
Arms & Interventions
Spinal Anesthesia with Intravenous Methadone
Experimental
Subjects will receive spinal anesthesia (intrathecal bupivacaine with fentanyl) with intravenous methadone
Intervention: Intravenous line (IV) Methadone (Drug)
Spinal Anesthesia with Intrathecal Morphine
Active Comparator
Subjects will receive spinal anesthesia (intrathecal bupivacaine with fentanyl) with intrathecal morphine
Intervention: Intrathecal Morphine (Drug)
Outcomes
Primary Outcomes
Total opioid consumption
Time Frame: 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 Outcomes
- 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)
- Richmond Agitation Sedation Scale (RASS)(12 hours, 24 hours, 36 hours, 48 hours)
Investigators
Emily E. Sharpe, M.D.
Principal Investigator
Mayo Clinic
Study Sites (1)
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