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Not yet recruitingNCT07786012Updated Sep 23, 2026

BUprenorphine Versus Morphine for Postcesarean Analgesia (BUMP)

A Phase 4 interventional study of buprenorphine and morphine in Cesarean Delivery, sponsored by Icahn School of Medicine at Mount Sinai. Not yet recruiting at 1 site in United States. Open to participants aged 19 Years and older. Per ClinicalTrials.gov, last updated 2026-09-23.

Sponsored by Icahn School of Medicine at Mount Sinai · Phase 4, Interventional, and Treatment

Phase
Phase 4
Study type
Interventional
Enrollment
180
Allocation
Randomized
Ages
19 Years and older
Sex
All
01

Study 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.

02

Conditions studied

  • Cesarean Delivery

Keywords

  • Cesarean Delivery
  • Pregnancy
  • postop pain
03

Who can participate

Ages eligible
19 Years and older
Sexes eligible
All
Accepts healthy volunteers
No

Inclusion criteria

- Presenting for singleton elective cesarean delivery at term gestation.

Exclusion criteria

Exclusion Criteria:

  • allergy to buprenorphine or morphine
  • will not have neuraxial anesthesia
  • chronic pain conditions
  • opiate based medications
04

Study design

Phase
Phase 4
Primary purpose
Treatment
Allocation
Randomized
Intervention model
Parallel assignment
Masking
Quadruple (Participant, Care provider, Investigator, Outcomes assessor)
Enrollment
180 participants (estimated)

Study arms

  • Experimental
    Buprenorphine

    Patients receive 60 mcg buprenorphine as a part of their spinal medications.

    Drug: buprenorphine

  • Active comparator
    Morphine

    Patients receive 125 mcg morphine as a part of their spinal medications

    Drug: morphine

Interventions

  • Drugbuprenorphine

    60 mcg buprenorphine intrathecal

  • Drugmorphine

    125mcg morphine intrathecal

05

What researchers measure

Primary outcomes

  1. 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.

    Time frame: 24 hours

Secondary outcomes

  1. 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.

    Time frame: 48 hours

  2. 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.

    Time frame: 72 hours

  3. 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.

    Time frame: 24 hours, 48 hours, and 72 hours post spinal administration

  4. Pruritus Scores PACU

    Pruritus scores full scale scored from 1-5 with higher score indicating more pruritus.

    Time frame: during PACU stay, about 6 hours

  5. 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.

    Time frame: at 24 hours intervals for 72 hours

  6. 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.

    Time frame: through 24 hours

06

Study locations

1 site
  • Mount Sinai Hospital
    New York, New York 10029, United States
07

References and documents

Individual participant data

Plan to share: No — The researchers may want to do a follow up study and reuse some of the data

No publications or documents are linked to this record.

08

Registry details

Key details

Study ID
NCT07786012
Lead sponsor
Icahn School of Medicine at Mount Sinai
Responsible party
Daniel Katz (Professor, Icahn School of Medicine at Mount Sinai) — Principal investigator
First posted
Aug 25, 2026
Start date
Sep 15, 2026 (estimated)
Primary completion
Aug 2028 (estimated)
Completion
Aug 2028 (estimated)
Last update
Sep 23, 2026

Study contacts

Daniel Katz
Contact
daniel.katz@mountsinai.org
212-241-7475
Daniel Katz
principal investigator · Icahn School of Medicine at Mount Sinai

Oversight

Data monitoring committee
No
FDA-regulated drug
Yes
FDA-regulated device
No
View the source record on ClinicalTrials.gov ↗

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