drugset / Trial / NCT01943565

Intrathecal Hydromorphone for Post-cesarean Delivery Pain - a Dose Finding Study

NCT01943565

Phase 4 Terminated 29 enrolled Brigham and Women's Hospital
RandomizedParallel-groupDouble-blindOther

Summary

Pain relief after cesarean delivery can be provided in a few ways. Most commonly, certain medications called opioids, such as morphine, are given through the vein or into the muscle. However, a more effective way to give pain relief with fewer side effects (such as nausea and slowing your breathing) is to give opioids in the spinal space as part of the medications given for a cesarean delivery. For many years, the opioid of choice was morphine due to its long anesthetic effect and acceptable side effect profile. A nation-wide disruption in the supply of preservative-free morphine has made it necessary to look for alternatives. Many institutions worldwide have used another opioid, called hydromorphone, in the spinal space for over a decade. This drug has a very good safety and side effect profile and has been used at the investigators' institution for more than a year. Of interest, while a number of different doses of hydromorphone have been used, there have been very few studies to evaluate the best dose for providing good pain relief with minimal side effects. The goal of this study is to find the best dose of spinal hydromorphone for women undergoing cesarean delivery.

Timeline

Start
2014-12
Primary completion
2016-07
Completion
2016-08

Drugs

EvaluationDrugModalityDoseRoute
Comparator Hydromorphone Other / unclassified 25 ug Other
Comparator Hydromorphone Other / unclassified 50 ug Other
Comparator Hydromorphone Other / unclassified 100 ug Other
Comparator Bupivacaine Other / unclassified 12 mg Other

Indications

No indication recorded.