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NCT Number: NCT07786012

BUprenorphine Versus Morphine for Postcesarean Analgesia (BUMP)

In this study the researchers are randomizing pregnant patients coming for elective cesarean delivery to receive either intrathecal buprenorphine or morphine for their analgesia.

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Key information

Conditions

Cesarean Delivery

Age range

19 year and older

Sex eligibility

All sexes

Study type

Interventional

Phase

Phase 4

Primary location

Mount Sinai Hospital

New York, 10029, United States

Location contact

Daniel Katz

PRINCIPAL_INVESTIGATOR

Daniel Katz, MD

CONTACT

[email protected]

212-241-7475

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

Inclusion criteria

  • Presenting for singleton elective cesarean delivery at term gestation.

Exclusion criteria

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

Treatment and study plan

buprenorphine

Drug

60 mcg buprenorphine intrathecal

Morphine

Drug

125mcg morphine intrathecal

Primary outcomes

  1. 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.

Secondary outcomes

  1. Morphine Equivalents at 48 Hours

    Time frame: 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.

  2. Morphine Equivalents at 72 Hours

    Time frame: 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.

  3. Obstetric Quality of Recovery-10 (ObsQoR-10) Score

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

    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.

  4. Pruritus Scores PACU

    Time frame: during PACU stay, about 6 hours

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

  5. Pruritus Scores POD1-3

    Time frame: at 24 hours intervals for 72 hours

    Pruritus scores full scale scored from 1-5 with higher score indicating more pruritus at 24 hour intervals for 3 days after spinal.

  6. Floor Pain Scores over 24 hours

    Time frame: through 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.

Study contacts

Contact information is provided by the study sponsor or research team.

Daniel Katz

CONTACT

[email protected]

212-241-7475

Sponsors and collaborators

Lead sponsor

Icahn School of Medicine at Mount Sinai

Other

Registry information

Official study title

The BUMP Trial: Intrathecal Buprenorphine Versus Morphine for Postcesarean Analgesia-A Randomized Noninferiority Trial

Important dates

Study start
2026
Primary completion
2028
Study completion
2028
First posted
Aug 25, 2026
Registry last updated
Aug 26, 2026

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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