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
- Are there results?
- Yes, posted in the registrySummary in the doctors' view
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
Show all 12Show fewer
- 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
Study at a glance
From the registry record, last updated by the sponsor on 21 Oct 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Intravenous Methadone Versus Intrathecal Morphine for Analgesia Following Cesarean Delivery: a Randomized Clinical Trial
- ClinicalTrials.gov ID
- NCT06826742
- Acronym / sponsor ID
- 24-000215
- Conditions
- Cesarean Delivery
- Keywords
- methadone, morphine, intrathecal, cesarean
- Phase
- Phase 4
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 30 participants (actual)
- Lead sponsor
- Mayo ClinicUniversity, hospital or other
- Study start
- 12 Feb 2025 (actual)
- Primary completion
- 14 Sep 2025 (actual)
- Study completion
- 23 Sep 2025 (actual)
- First posted
- 14 Feb 2025 (actual)
- Results
- Posted 21 Oct 2026
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Triple blind (participant, investigator, outcomes assessor)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Spinal Anesthesia with Intravenous Methadone | Experimental | Drug: Intravenous line (IV) MethadoneSubjects will receive spinal anesthesia (intrathecal bupivacaine with fentanyl) with intravenous methadone |
| Spinal Anesthesia with Intrathecal Morphine | Active comparator | Drug: Intrathecal MorphineSubjects will receive spinal anesthesia (intrathecal bupivacaine with fentanyl) with intrathecal morphine |
Who may qualify
- Ages
- 18 years and older
- Sex
- Female only
- Healthy volunteers
- Accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (3 listed)
- English-speaking
- Age over 18 years old
- Scheduled cesarean delivery
Key exclusion criteria (12 listed)
- 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
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Intravenous line (IV) MethadoneSubjects 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. | Drug | Spinal Anesthesia with Intravenous Methadone |
| Intrathecal MorphineSubjects 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. | Drug | Spinal Anesthesia with Intrathecal Morphine |
Primary outcome
Total Opioid Consumption
Time frame: 24 hours post-delivery, 48 hours post-delivery
Total opioid consumption (Morphine Milligram Equivalent) of either intrathecal opiate or intravenous methadone at 24-48 hours after delivery.
9 secondary outcomes
Obstetric Quality of Recovery-10 (ObsQoR-10) Scoring Tool
Time frame: 24 hours, 48 hours, 7 days
Numeric Rating Scale (NRS) Pain Score at Rest
Time frame: 12 hours, 24 hours, 36 hours, 48 hours, 7 days
Numeric Rating Scale (NRS) for Movement-evoked Pain
Time frame: 12 hours, 24 hours, 36 hours, 48 hours, 7 days
Numeric Rating Scale (NRS) for Pain in Previous 24 Hours
Time frame: 12 hours, 24 hours, 36 hours, 48 hours, 7 days
Pruritus
Time frame: 12 hours, 24 hours, 36 hours, 48 hours
Richmond Agitation Sedation Scale (RASS)
Time frame: 12 hours, 24 hours, 36 hours, 48 hours
Nausea
Time frame: 12 hours, 24 hours, 36 hours, 48 hours
Patient Health Questionnaire-9 (PHQ-9) Score
Time frame: 7 days
Global Health State
Time frame: 24 hours, 48 hours, 7 days
Results and safety
Loading the posted results from ClinicalTrials.gov…
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 21 Oct 2026.
- Posted resultsParticipant flow, baseline, all outcome measures and adverse events.
- Mayo Clinic Clinical TrialsLink provided by the sponsor.
- Individual participant dataSharing planned: No
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Emily E Sharpe, M.D. principal investigator
Mayo Clinic
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
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.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 3 inclusion and 12 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 21 Oct 2026. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in United States. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
What does this phase mean?
Phase 4 studies take place after a treatment is approved, to learn more about its long-term benefits and risks in everyday use.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
Are results available for this study?
Yes. Results are posted in the registry (first posted 21 Oct 2026). A summary is in the For doctors view, and the full results are on ClinicalTrials.gov.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Total Opioid Consumption (time frame: 24 hours post-delivery, 48 hours post-delivery). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 21 Oct 2026.