Icahn School of Medicine at Mount Sinai
New York, 10029, United States
NCT Number: NCT02096003
The use of intrathecal opioids for analgesia in the setting of cesarean section has become standard obstetric anesthesia practice. Currently, two opioids are commonly used. These opioids are fentanyl and morphine (Duramorph). Intrathecal opioids are an excellent source of analgesia and act to reduce the stress response to surgery.
Currently, most obstetric anesthesiologists use intrathecal morphine for analgesia after cesarean delivery. Morphine provides excellent analgesia for cesarean section. However, use of this medication is associated with side effects such as pruritus and nausea and vomiting.
Recently, multiple obstetric anesthesia groups began to use intrathecal hydromorphone for cesarean delivery when morphine was unavailable. As groups began to use hydromorphone, retrospective data became available that demonstrated its safety and efficacy for use during cesarean section.
In order to fully elucidate the analgesic and side effect properties of hydromorphone for cesarean delivery, a prospective randomized, double blind study comparing morphine and hydromorphone is necessary. The investigators need to understand whether hydromorphone is as effective as morphine for analgesia after cesarean section, and whether it is associated with fewer or more side effects. The results of the study will allow providers to make educated decisions to better care for their patient.
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Notify Me18 year–40 year
Female
Interventional
Phase 2
New York, 10029, United States
Healthy volunteers accepted: Yes
Only the study team can determine whether someone qualifies for participation.
Inclusion criteria
Exclusion criteria
0.25mg intrathecal morphine is the standard opioid medication the investigators use for analgesia for cesarean sections. It is the control arm.
Other names: Duramorph
50mcg intrathecal hydromorphone will be added to 1.5mg 0.75% bupivicaine for single shot spinal anesthesia.
Other names: Dilaudid
Time frame: at 24 hours
Total dose of fentanyl patient controlled analgesia (pca) used in 24 hours post-op.
Time frame: up to 24 hours
When does the patient need to use the PCA for the first time? This will be used to assess when morphine and hydromorphone first begin to provide analgesia.
Time frame: at 24 hours
Assess pain scores on a scale of 1-5, with higher score indicating more pain.
Time frame: at 24 hours
Patient satisfaction score - total scale of 1-5, with higher score indicating more satisfaction
Time frame: up to 24 hours
Symptom scale for nausea and pruritus. Full scale from 1-5, with higher score indicating more symptoms.
Icahn School of Medicine at Mount Sinai
Other
Comparison of Intrathecal Hydromorphone and Intrathecal Morphine for Postoperative Analgesia After Cesarean Delivery
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