drugset / Trial / NCT02096003

Intrathecal Hydromorphone for Pain Control After Cesarean Section

NCT02096003

Phase 2 Completed 80 enrolled Icahn School of Medicine at Mount Sinai
RandomizedParallel-groupQuadruple-blindTreatment

Summary

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.

Timeline

Start
2014-05
Primary completion
2017-05-05
Completion
2017-05-05

Drugs

EvaluationDrugModalityDoseRoute
Subject Hydromorphone Other / unclassified 50 ug Intrathecal
Comparator Morphine Other / unclassified 0.25 mg Intrathecal

Indications

No indication recorded.