Health TrialsbyHealthPanel

BUprenorphine Versus Morphine for Postcesarean Analgesia (BUMP)

ConditionCesarean Delivery
Trial statusNot yet recruiting
Trial phasePhase 4
Trial typeInterventional
Biological sexAll
Age19+
SponsorIcahn School of Medicine at Mount Sinai

About this 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.

Eligibility criteria

This trial does not accept healthy volunteers

Qualifiers

None

Disqualifiers

allergy to buprenorphine or morphine

will not have neuraxial anesthesia

chronic pain conditions

opiate based medications

Trial design

Design model

Parallel

Treatments tested in this trial

  • buprenorphine

    Drug

    60 mcg buprenorphine intrathecal

  • morphine

    Drug

    125mcg morphine intrathecal

Treatment groups

180 Participants
are divided into 2 treatment groups
Group A: BuprenorphineExperimental treatment 1 intervention
Group B: MorphineActive comparator 1 intervention

Trial outcomes

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

Other outcomes

Sponsors and contacts

Click on the lead sponsor to view all of their trials.

Icahn School of Medicine at Mount Sinai

Lead sponsor

Source ClinicalTrials.gov

This trial is not recruiting at the moment. You can still explore other options: