Phase 4
N=84
Intrathecal Opioids for Pain Control After Cesarean Delivery: Determining the Optimal Dose
Analgesia, Obstetrical · Cesarean Section
Bottom Line
View on ClinicalTrials.gov: NCT02009722 ↗Enrolled (actual)
84
Serious AEs
0.0%
Results posted
May 2016
Primary outcome: Primary: Dose of IT Morphine and IT Hydromorphone for Adequate Analgesia (Pain Score Less Than or Equal to 3) in 90% of Patients — 75; 150 micrograms
Study Design & Population
- Study type
- Interventional
- Phase
- Phase 4
- Interventions
- Morphine (Drug); Hydromorphone (Drug)
- Age
- Adult, Older Adult · 18+ yrs
- Sex
- Female
- Sponsor
- Mayo Clinic
- Primary completion
- Dec 2014
Outcome Measures
| Outcome | Result | p-value |
|---|---|---|
| PRIMARY Dose of IT Morphine and IT Hydromorphone for Adequate Analgesia (Pain Score Less Than or Equal to 3) in 90% of Patients |
75; 150 | — |
| SECONDARY Side Effects: Pruritus |
23; 19 | — |
| SECONDARY Side Effects: Nausea |
11; 16 | — |
| SECONDARY Side Effects: Sedation |
0; 0 | — |
| SECONDARY Pruritus |
8; 8 | — |
| SECONDARY Pruritus |
8; 8 | — |
| SECONDARY Nausea |
1; 4 | — |
| SECONDARY Nausea |
1; 4 | — |
| SECONDARY Treatment for Nausea |
13; 17 | — |
| SECONDARY Treatment for Pruritus |
8; 4 | — |
Summary
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.
Eligibility Criteria
Inclusion Criteria
- 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
Exclusion Criteria
- 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
Data sourced from ClinicalTrials.gov (NCT02009722). Outcome figures and adverse-event rates are extracted automatically from the registry's posted results and are provided for clinician reference, not as a substitute for the primary publication.