Pain
Conditions
Keywords
Hydromorphone, Morphine, cesarean delivery, pain management, respiratory depression
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.
Interventions
DRUGHydromorphone
Injection of 100 mcg hydromorphone into the intrathecal space
DRUGMorphine
Injection of 200 mcg of intrathecal morphine
Sponsors
Masimo Corporation
Grace Shih, MD
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT
Masking
SINGLE (Subject)
Eligibility
Sex/Gender
FEMALE
Age
18 Years to 40 Years
Healthy volunteers
Yes
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
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Change in Pain Scores | 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
| Measure | Time frame | Description |
|---|---|---|
| Number of Participants with Adverse Events (AEs) | up to 24 Hours | Patients will be monitored hourly for first 12 hours followed by every 2 hours for the next 12 hours. Masimo acoustic monitor will monitor respirations. |
Countries
United States
Outcome results
None listed