Cesarean DeliveryPhase 4NCT06826742
Intravenous Methadone Versus Intrathecal Morphine for Analgesia Following Cesarean Delivery
A Phase 4 study testing Intravenous line (IV) Methadone and Intrathecal Morphine in people with Cesarean Delivery, run by Mayo Clinic at 1 site in United States.
Trial 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. Read more about this study
- Who is it for?
- Ages 18 years and older, women onlyHealthy volunteers can take part
- Conditions the study is for
- Cesarean Delivery
- What is being tested?
- Intravenous line (IV) Methadone and Intrathecal Morphine
- Type of treatment
- Injection or infusion
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 30 participants
- Where
- 1 siteUnited States
- Study dates
- 12 Feb 2025to 23 Sep 2025
- Phase
- Phase 4
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- Women only
- Healthy volunteers accepted
- Adult, Older adult
Who may be able to join
- English-speaking
- Age over 18 years old
- Scheduled cesarean delivery
Who cannot join
- 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
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- 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
Trial locations and contacts
1 site in 1 country.
United States1 site
Mayo Clinic in Rochester
Rochester, Minnesota, 55905
About this study
Official title: 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.
- Conditions
- Cesarean Delivery
- Being tested
- Intravenous line (IV) Methadone, Intrathecal Morphine
- Keywords
- methadone, morphine, intrathecal, cesarean
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Intravenous line (IV) MethadoneDrug
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.
Intrathecal MorphineDrug
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.
| Study group | Role | What they receive |
|---|---|---|
| Spinal Anesthesia with Intravenous Methadone | Experimental | Subjects will receive spinal anesthesia (intrathecal bupivacaine with fentanyl) with intravenous methadone Receives: Drug: Intravenous line (IV) Methadone |
| Spinal Anesthesia with Intrathecal Morphine | Active comparator | Subjects will receive spinal anesthesia (intrathecal bupivacaine with fentanyl) with intrathecal morphine Receives: Drug: Intrathecal Morphine |
What is being measured
The primary outcome is the main question the study is designed to answer.
Total Opioid Consumption
Total opioid consumption (Morphine Milligram Equivalent) of either intrathecal opiate or intravenous methadone at 24-48 hours after delivery.
Measured: 24 hours post-delivery, 48 hours post-delivery
Secondary outcomes (9)
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.
Measured: 24 hours, 48 hours, 7 days
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". Higher scores indicate worse pain.
Measured: 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". Higher scores indicate worse pain.
Measured: 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". Higher scores indicate worse pain.
Measured: 12 hours, 24 hours, 36 hours, 48 hours, 7 days
Pruritus
The severity of pruritus post spinal administration will be patient-reported on a 0-10 rating scale where 0 = none and 10 = severe. Higher scores indicate worse pruritus.
Measured: 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, with higher scores indicating more agitated behavior.
Measured: 12 hours, 24 hours, 36 hours, 48 hours
Nausea
The severity of nausea post spinal administration will be patient-reported on a 10-point scale where 0 = no nausea and 10 = worse nausea imaginable. Higher scores indicate worse nausea.
Measured: 12 hours, 24 hours, 36 hours, 48 hours
Patient Health Questionnaire-9 (PHQ-9) Score
The Patient Health Questionnaire-9 (PHQ-9) is a nine-item self-administered questionnaire used to screen for depression severity. Each item is scored from 0 (not at all) to 3 (nearly every day). The total score ranges from 0 to 27, with higher scores indicating more severe depressive symptoms. The outcome was measured as the number of subjects who experienced minimal symptoms (score range 0-4), mild symptoms (score range 5-9), moderate symptoms (score range 10-14), moderately severe symptoms (score range 15-19) or severe symptoms (score range 20-27).
Measured: 7 days
Global Health State
The Global Health State will be measured via Visual Analogue Scale to gauge the patient's overall assessment of their health on a scale from 0 (worst health imaginable) to 100 (best health imaginable). Higher scores indicate better health.
Measured: 24 hours, 48 hours, 7 days
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted14 Feb 2025
- Study start12 Feb 2025
- Primary completion14 Sep 2025
- Study completion23 Sep 2025
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Posted resultsParticipant flow, outcome measures and adverse events reported by the sponsor.
- Other trials for Cesarean DeliveryStudies of the same condition, open and under way.
- More trials run by Mayo ClinicThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase 4
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Triple blind
- Who is masked
- Participant, Investigator, Outcomes assessor
- Enrolment
- 30 participants (actual)
Sponsor and investigators
- Lead sponsor
- Mayo Clinic
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Emily E. Sharpe, M.D., Mayo Clinic
- Investigators
- Emily E Sharpe, M.D., Principal investigator, Mayo Clinic
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06826742
- Sponsor's protocol ID
- 24-000215
- Status last verified
- Oct 2026
- First submitted
- 10 Feb 2025
- Last updated
- 21 Oct 2026
- Results posted
- Yes, on ClinicalTrials.gov
- Data monitoring committee
- No
- FDA-regulated drug
- Yes
- FDA-regulated device
- No
- Individual data sharing
- No