Clinical Trials Directory

Trials / Completed

CompletedNCT01866254

Use of Intrathecal Hydromorphone in Elective Cesarean Deliveries

Status
Completed
Phase
EARLY_Phase 1
Study type
Interventional
Enrollment
45 (actual)
Sponsor
Grace Shih, MD · Academic / Other
Sex
Female
Age
18 Years – 40 Years
Healthy volunteers
Accepted

Summary

The purpose of this study is to determine if intrathecal hydromorphone will relieve pain as well as intrathecal morphine after cesarean delivery, with fewer side effects.

Detailed description

Intrathecal morphine has long been the standard pain medication used in cesarean sections. Since some patients cannot tolerate morphine, hydromorphone may be an acceptable alternative. Intrathecal Intrathecal hydromorphone has been shown to be effective at treating post cesarean section pain and possibly with less side effects than morphine. One side effect of morphine is respiratory depression occurring hours after the start of morphine use. Respiratory depression occurs when air being taken into the lungs is less than normal, leading to a lower amount of oxygen and carbon dioxide being exchanged in the blood stream. Because hydromorphone dosages are lower and it has a quicker onset of action than morphine, it is believed that the use of hydromorphone should decrease the possibility of delayed respiratory depression.

Conditions

Interventions

TypeNameDescription
DRUGHydromorphoneInjection of 100 mcg hydromorphone into the intrathecal space
DRUGMorphineInjection of 200 mcg of intrathecal morphine

Timeline

Start date
2013-05-01
Primary completion
2017-12-04
Completion
2018-10-22
First posted
2013-05-31
Last updated
2019-01-03

Locations

1 site across 1 country: United States

Source: ClinicalTrials.gov record NCT01866254. Inclusion in this directory is not an endorsement.