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

• Status: Terminated
• Trial end date: 2016-08-01
• Target enrollment: 0
• Participant gender: Female

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.

• Phase: Phase 4
• Accepts Healthy Volunteers?: Accepts Healthy Volunteers

Details

• Lead Sponsor: Brigham and Women's Hospital
• Treatments: Hydromorphone

Criteria

Inclusion Criteria:

• Healthy at-term parturients undergoing elective cesarean delivery under spinal anesthesia

Exclusion Criteria:

• Emergency cesarean delivery

• Respiratory disease

• significant comorbidities: preeclampsia, insulin-dependent diabetes mellitus

• obstructive sleep apnea

• body mass index > 35kg/m2

• <18yrs

• documented intolerance or allergy to systemic or neuraxial opioids

• patient with a history of chronic opioid or current use of opioids