Cesarean Delivery
Conditions
Keywords
Cesarean Delivery, Pregnancy, postop pain
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.
Interventions
DRUGbuprenorphine
60 mcg buprenorphine intrathecal
DRUGmorphine
125mcg morphine intrathecal
Sponsors
Icahn School of Medicine at Mount Sinai
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT
Masking
QUADRUPLE (Subject, Caregiver, Investigator, Outcomes Assessor)
Masking description
Assignments done via opaque envelopes. Separate team will break envelopes and draw up study medication.
Eligibility
Sex/Gender
ALL
Age
19 Years to No maximum
Healthy volunteers
No
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
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Morphine equivalents administered within 24 hours after spinal administration | 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
| Measure | Time frame | Description |
|---|---|---|
| Morphine Equivalents at 48 Hours | 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. |
| Morphine Equivalents at 72 Hours | 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. |
| Obstetric Quality of Recovery-10 (ObsQoR-10) Score | 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. |
| Pruritus Scores PACU | during PACU stay, about 6 hours | Pruritus scores full scale scored from 1-5 with higher score indicating more pruritus. |
| Pruritus Scores POD1-3 | 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. |
| Floor Pain Scores over 24 hours | 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. |
Countries
United States
Contacts
CONTACTDaniel Katz
PRINCIPAL_INVESTIGATORDaniel Katz
Icahn School of Medicine at Mount Sinai
Outcome results
None listed