Use of Intrathecal Hydromorphone in Elective Cesarean Deliveries
Information source: University of Kansas
ClinicalTrials.gov processed this data on August 23, 2015 Link to the current ClinicalTrials.gov record.
Condition(s) targeted: Pain
Intervention: Hydromorphone (Drug); Morphine (Drug)
Phase: Phase 0
Status: Recruiting
Sponsored by: Grace Shih, MD Official(s) and/or principal investigator(s): Grace Shih, MD, Principal Investigator, Affiliation: University of Kansas
Overall contact: Stephanie Thomas-Dodson, RN, BSN, Phone: (913) 588-0057, Email: sthomas-dodson@kumc.edu
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.
Clinical Details
Official title: Use of Intrathecal Hydromorphone in Elective Cesarean Deliveries
Study design: Allocation: Randomized, Endpoint Classification: Safety/Efficacy Study, Intervention Model: Parallel Assignment, Masking: Single Blind (Subject), Primary Purpose: Treatment
Primary outcome: Change in Pain Scores
Secondary outcome: Number of Participants with Adverse Events (AEs)
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.
Eligibility
Minimum age: 18 Years.
Maximum age: 40 Years.
Gender(s): Female.
Criteria:
Inclusion Criteria:
- 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 Criteria:
- 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
Locations and Contacts
Stephanie Thomas-Dodson, RN, BSN, Phone: (913) 588-0057, Email: sthomas-dodson@kumc.edu
University of Kansas Medical Center, Kansas City, Kansas 66160, United States; Recruiting Katherine Stiles, MD, Sub-Investigator Martin DeRuyter, MD, Sub-Investigator Stephanie Thomas-Dodson, RN, BSN, Sub-Investigator
Additional Information
Starting date: May 2013
Last updated: June 25, 2015
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