Use of Intrathecal Hydromorphone in Elective Cesarean Deliveries
Overview
- Phase
- Early Phase 1
- Intervention
- Hydromorphone
- Conditions
- Pain
- Sponsor
- Grace Shih, MD
- Enrollment
- 45
- Locations
- 1
- Primary Endpoint
- Change in Pain Scores
- Status
- Completed
- Last Updated
- 7 years ago
Overview
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 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.
Investigators
Grace Shih, MD
Associate Professor
University of Kansas Medical Center
Eligibility 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
Arms & Interventions
Hydromorphone
100 mg, intrathecal administration
Intervention: Hydromorphone
Morphine
200 mg, intrathecal administration
Intervention: Morphine
Outcomes
Primary Outcomes
Change in Pain Scores
Time Frame: from Baseline to 24 Hours
Pain scores to be measured using the verbal response scale (VRS). The VRS pain score is measured on a scale of 0-10 with 0 representing absolutely no pain and 10 representing worst pain imaginable
Secondary Outcomes
- Number of Participants with Adverse Events (AEs)(up to 24 Hours)