Intrathecal Opioids for Pain Control After Cesarean Delivery: Determining the Optimal Dose
Completed · Phase 4
Conditions studied: Analgesia, Obstetrical, Cesarean Section
In brief
Both hydromorphone and morphine are administered as part of spinal anesthesia to help improve pain control after cesarean delivery. In this study, the investigators are going to determine the doses of each of those medicines that provides optimal pain control to women undergoing cesarean delivery while limiting side effects related to those medicines. The investigators hypothesize that the doses of hydromorphone and morphine that provide optimal pain control without significant side effects will be 100 micrograms and 150 micrograms, respectively. The investigators further hypothesize that at each respective optimal dose, side effects will be less in the hydromorphone group.
Key facts
- Study ID
- NCT02009722
- Run by
- Mayo Clinic
- People needed
- 84
- Starts
- 2014-01-01
- Expected to finish
- 2015-04-01
- Last updated by the study team
- 2016-07-25
Who can join
Age: 18 and older. Sex: female. Healthy volunteers: not accepted.
You may qualify if…
- Women presenting for elective cesarean delivery with no major co-morbidities, including pregnancy induced co-morbidities (e.g. pre-eclampsia)
- Singleton gestation at term (37-42 weeks)
- Desire to have a spinal anesthesia technique for cesarean delivery
You may not qualify if…
- Current or historical evidence of clinically significant medical disease or condition
- Any contraindication to the administration of a spinal technique for anesthesia
- History of hypersensitivity or idiosyncratic reaction to opioid medications
- Chronic pain syndrome or current regular opioid use
- Evidence of anticipated fetal anomalies
- Allergy or intolerance to Tylenol, ketorolac, ibuprofen, or oxycodone
- BMI > 40
Where it is running
- Rochester Methodist Hospital, Mayo Clinic — Rochester, Minnesota, United States
Full record on ClinicalTrials.gov
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