BUprenorphine Versus Morphine for Postcesarean Analgesia (BUMP)

NCT07786012 | Not Yet Recruiting Phase 4 FDA Drug

• 1 other identifier: STUDY-26-00705
• Study Type: interventional
• Target: 180
• Locations: 1 country
• Sites: 1

Brief 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.

Conditions

Cesarean Delivery

Keywords

Cesarean Delivery; Pregnancy; postop pain

Outcome Measures

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.

  24 hours

Secondary Outcomes (6)

• Morphine Equivalents at 48 Hours

  48 hours

• Morphine Equivalents at 72 Hours

  72 hours

• Obstetric Quality of Recovery-10 (ObsQoR-10) Score

  24 hours, 48 hours, and 72 hours post spinal administration

• Pruritus Scores PACU

  during PACU stay, about 6 hours

• Pruritus Scores POD1-3

  at 24 hours intervals for 72 hours

Study Arms (2)

Buprenorphine

EXPERIMENTAL

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

Drug: buprenorphine

Morphine

ACTIVE COMPARATOR

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

Drug: morphine

Interventions

buprenorphine DRUG

60 mcg buprenorphine intrathecal

Buprenorphine

morphine DRUG

125mcg morphine intrathecal

Morphine

Eligibility Criteria

• Age: 19 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• \- Presenting for singleton elective cesarean delivery at term gestation.

You may not qualify if:

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

Sponsors & Collaborators

• Icahn School of Medicine at Mount Sinai: lead

Study Sites (1)

Mount Sinai Hospital

New York, New York, 10029, United States

Location

MeSH Terms

Interventions

Buprenorphine; Morphine

Intervention Hierarchy (Ancestors)

Morphinans; Opiate Alkaloids; Alkaloids; Heterocyclic Compounds; Heterocyclic Compounds, Bridged-Ring; Heterocyclic Compounds, 4 or More Rings; Heterocyclic Compounds, Fused-Ring; Phenanthrenes; Polycyclic Aromatic Hydrocarbons; Polycyclic Compounds; Morphine Derivatives

Study Officials

• Daniel Katz

  Icahn School of Medicine at Mount Sinai

  PRINCIPAL INVESTIGATOR

Central Study Contacts

Daniel Katz

CONTACT

212-241-7475; daniel.katz@mountsinai.org

Study Design

• Study Type: interventional
• Phase: phase 4
• Allocation: RANDOMIZED
• Masking: QUADRUPLE
• Who Masked: PARTICIPANT, CARE PROVIDER, INVESTIGATOR, OUTCOMES ASSESSOR
• Masking Details: Assignments done via opaque envelopes. Separate team will break envelopes and draw up study medication.
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Professor

Study Record Dates

• First Submitted: August 21, 2026
• First Posted: August 25, 2026
• Study Start: August 1, 2026
• Primary Completion (Estimated): August 1, 2028
• Study Completion (Estimated): August 1, 2028
• Last Updated: August 26, 2026

Record last verified: 2026-08

Data Sharing

• IPD Sharing: Will not share

Locations

US (1)