Status:
COMPLETED
Use of Intrathecal Hydromorphone in Elective Cesarean Deliveries
Lead Sponsor:
Grace Shih, MD
Collaborating Sponsors:
Masimo Corporation
Conditions:
Pain
Eligibility:
FEMALE
18-40 years
Phase:
EARLY_PHASE1
Brief 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 Int...
Eligibility Criteria
Inclusion
- Scheduled for elective Cesarean sections under spinal anesthesia or combined spinal anesthesia
- ASA status of I-III
- BMI \< 40
- Able to understand and sign informed consent
Exclusion
- Severe pre-eclampsia
- Conversion to general anesthetic
- History of chronic opioid use
- Allergy to morphine, or hydromorphone
- Hyperemesis gravidarum
- Emergency case
- Patients who have an infection at the intended site of spinal insertion
Key Trial Info
Start Date :
May 1 2013
Trial Type :
INTERVENTIONAL
Allocation :
ACTUAL
End Date :
October 22 2018
Estimated Enrollment :
45 Patients enrolled
Trial Details
Trial ID
NCT01866254
Start Date
May 1 2013
End Date
October 22 2018
Last Update
January 3 2019
Active Locations (1)
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1
University of Kansas Medical Center
Kansas City, Kansas, United States, 66160