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
In this study the researchers are randomizing pregnant patients coming for elective cesarean delivery to receive either intrathecal buprenorphine or morphine for their analgesia.
- Presenting for singleton elective cesarean delivery at term gestation.
Exclusion Criteria:
Patients receive 60 mcg buprenorphine as a part of their spinal medications.
Drug: buprenorphine
Patients receive 125 mcg morphine as a part of their spinal medications
Drug: morphine
60 mcg buprenorphine intrathecal
125mcg morphine intrathecal
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
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
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
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
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
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
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
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.
This study is not yet recruiting, as verified in Sep 2026. You cannot join it, but the record below documents what was studied.
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Icahn School of Medicine at Mount Sinai