Cesarean DeliveryPhase 4NCT07786012
BUprenorphine Versus Morphine for Postcesarean Analgesia (BUMP)
A Phase 4 study testing buprenorphine and morphine in people with Cesarean Delivery, run by Icahn School of Medicine at Mount Sinai at 1 site in United States.
Trial summary
In this study the researchers are randomizing pregnant patients coming for elective cesarean delivery to receive either intrathecal buprenorphine or morphine for their analgesia. Read more about this study
- Who is it for?
- Ages 19 years and older
- Conditions the study is for
- Cesarean Delivery
- What is being tested?
- buprenorphine and morphine
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 180 participants
- Where
- 1 siteUnited States
- Study dates
- 7 Oct 2026to Aug 2028
- Phase
- Phase 4
- Are there results?
- Not yet: the study is under way
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 19 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Presenting for singleton elective cesarean delivery at term gestation.
Who cannot join
- allergy to buprenorphine or morphine
- will not have neuraxial anesthesia
- chronic pain conditions
- opiate based medications
Trial locations and contacts
1 site in 1 country. Contact the study team or a site near you to ask about taking part.
United States1 site, 1 recruiting
- Recruiting
Mount Sinai Hospital
New York, New York, 10029
Daniel Katz, MD, 212-241-7475, daniel.katz@mountsinai.org
Daniel Katz
About this study
Official title: The BUMP Trial: Intrathecal Buprenorphine Versus Morphine for Postcesarean Analgesia-A Randomized Noninferiority Trial
In this study the researchers are randomizing pregnant patients coming for elective cesarean delivery to receive either intrathecal buprenorphine or morphine for their analgesia.
- Conditions
- Cesarean Delivery
- Being tested
- buprenorphine, morphine
- Keywords
- Cesarean Delivery, Pregnancy, postop pain
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
buprenorphineDrug
60 mcg buprenorphine intrathecal
morphineDrug
125mcg morphine intrathecal
| Study group | Role | What they receive |
|---|---|---|
| Buprenorphine | Experimental | Patients receive 60 mcg buprenorphine as a part of their spinal medications. Receives: Drug: buprenorphine |
| Morphine | Active comparator | Patients receive 125 mcg morphine as a part of their spinal medications Receives: Drug: morphine |
What is being measured
The primary outcome is the main question the study is designed to answer.
Morphine equivalents administered within 24 hours after spinal administration
The total sum of opiates will be converted into morphine equivalents and compared between the groups for the first 24 hours after the spinal is administered.
Measured: 24 hours
Secondary outcomes (6)
Morphine Equivalents at 48 Hours
The total sum of opiates will be converted into morphine equivalents and compared between the groups for the first 48 hours after the spinal is administered.
Measured: 48 hours
Morphine Equivalents at 72 Hours
The total sum of opiates will be converted into morphine equivalents and compared between the groups for the first 72 hours after the spinal is administered.
Measured: 72 hours
Obstetric Quality of Recovery-10 (ObsQoR-10) Score
Recovery score of the OBSQOR10 instrument at 24 hours, 48 hours, and 72 hours post spinal.
Obstetric Quality of Recovery-10 (ObsQoR-10) is a 10-item instrument. Full scale is scored from 0-100 with higher score indicating better health outcomes.
Measured: 24 hours, 48 hours, and 72 hours post spinal administration
Pruritus Scores PACU
Pruritus scores full scale scored from 1-5 with higher score indicating more pruritus.
Measured: during PACU stay, about 6 hours
Pruritus Scores POD1-3
Pruritus scores full scale scored from 1-5 with higher score indicating more pruritus at 24 hour intervals for 3 days after spinal.
Measured: at 24 hours intervals for 72 hours
Floor Pain Scores over 24 hours
Pain scores obtain by nursing team over the first 24 hours while on regular hospital floor. Pain scored from 0-10, with higher score indicating more pain.
Measured: through 24 hours
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted25 Aug 2026
- Study start7 Oct 2026
- Primary completionAug 2028 (estimated)
- Study completionAug 2028 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Cesarean DeliveryStudies of the same condition, open and under way.
- More trials run by Icahn School of Medicine at Mount SinaiThe 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
- Quadruple blind
- Who is masked
- Participant, Care provider, Investigator, Outcomes assessor
- Enrolment
- 180 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Icahn School of Medicine at Mount Sinai
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Daniel Katz, Icahn School of Medicine at Mount Sinai
- Investigators
- Daniel Katz, Principal investigator, Icahn School of Medicine at Mount Sinai
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT07786012
- Sponsor's protocol ID
- STUDY-26-00705
- Status last verified
- Oct 2026
- First submitted
- 21 Aug 2026
- Last updated
- 16 Oct 2026
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- Yes
- FDA-regulated device
- No
- Individual data sharing
- No: The researchers may want to do a follow up study and reuse some of the data
Study at a glance
From the registry record, last updated by the sponsor on 16 Oct 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- The BUMP Trial: Intrathecal Buprenorphine Versus Morphine for Postcesarean Analgesia-A Randomized Noninferiority Trial
- ClinicalTrials.gov ID
- NCT07786012
- Acronym / sponsor ID
- STUDY-26-00705
- Conditions
- Cesarean Delivery
- Keywords
- Cesarean Delivery, Pregnancy, postop pain
- Phase
- Phase 4
- Study type
- Interventional
- Recruitment status
- Recruiting
- Enrolment
- 180 participants (estimated)
- Lead sponsor
- Icahn School of Medicine at Mount SinaiUniversity, hospital or other
- Study start
- 7 Oct 2026 (actual)
- Primary completion
- Aug 2028 (estimated)
- Study completion
- Aug 2028 (estimated)
- First posted
- 25 Aug 2026 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
In this study the researchers are randomizing pregnant patients coming for elective cesarean delivery to receive either intrathecal buprenorphine or morphine for their analgesia.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Quadruple blind (participant, care provider, investigator, outcomes assessor)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Buprenorphine | Experimental | Drug: buprenorphinePatients receive 60 mcg buprenorphine as a part of their spinal medications. |
| Morphine | Active comparator | Drug: morphinePatients receive 125 mcg morphine as a part of their spinal medications |
Who may qualify
- Ages
- 19 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (1 listed)
- Presenting for singleton elective cesarean delivery at term gestation.
Key exclusion criteria (4 listed)
- allergy to buprenorphine or morphine
- will not have neuraxial anesthesia
- chronic pain conditions
- opiate based medications
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 |
|---|---|---|
| buprenorphine60 mcg buprenorphine intrathecal | Drug | Buprenorphine |
| morphine125mcg morphine intrathecal | Drug | Morphine |
Primary outcome
Morphine equivalents administered within 24 hours after spinal administration
Time frame: 24 hours
The total sum of opiates will be converted into morphine equivalents and compared between the groups for the first 24 hours after the spinal is administered.
6 secondary outcomes
Morphine Equivalents at 48 Hours
Time frame: 48 hours
Morphine Equivalents at 72 Hours
Time frame: 72 hours
Obstetric Quality of Recovery-10 (ObsQoR-10) Score
Time frame: 24 hours, 48 hours, and 72 hours post spinal administration
Pruritus Scores PACU
Time frame: during PACU stay, about 6 hours
Pruritus Scores POD1-3
Time frame: at 24 hours intervals for 72 hours
Floor Pain Scores over 24 hours
Time frame: through 24 hours
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 16 Oct 2026.
- Individual participant dataSharing planned: No. The researchers may want to do a follow up study and reuse some of the data
Related trials for Cesarean Delivery
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Adverse Event, Hypotension (MeSH: D007022)
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Not yet recruitingObservational study
Evaluation of Consciousness Depth (qCON) and Analgesia Depth (qNOX) Indices in General Anesthesia
Cesarean Section (MeSH: D002585), Anesthesia
RecruitingPhase 4
Norepinephrine With Ephedrine Versus Norepinephrine Alone During Spinal Anesthesia for Cesarean Delivery
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COMFORT Trial: Complex Obstetric Management With Focused Regional Transversus Abdominis Plane Block
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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.
Daniel Katz principal investigator
Icahn School of Medicine at Mount Sinai
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 buprenorphine and morphine in people with Cesarean Delivery, run by Icahn School of Medicine at Mount Sinai 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 1 inclusion and 4 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: looking for participants now, as of the sponsor's last update on 16 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?
This study is still under way. Results are not available in the source record yet.
How can a doctor refer a patient or contact the research team?
Contact Daniel Katz (212-241-7475, daniel.katz@mountsinai.org), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Morphine equivalents administered within 24 hours after spinal administration (time frame: 24 hours). 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 16 Oct 2026.