Phase 4
N=239
Superiority Study for Pain Treatment After Cesarean
Pain
Bottom Line
View on ClinicalTrials.gov: NCT01115101 ↗Enrolled (actual)
239
Serious AEs
0.0%
Results posted
Feb 2013
Primary outcome: Primary: Difference of Pain Scores on the Visual Analog Scale — 5.88; 4.85 VAS score at 24 hours — p=<0.05
Study Design & Population
- Study type
- Interventional
- Phase
- Phase 4
- Interventions
- Oral Oxycodon (Drug); Piritramid (Drug)
- Age
- Adult, Older Adult · 18+ yrs
- Sex
- Female
- Sponsor
- Max Dieterich
- Primary completion
- Nov 2009
Outcome Measures
| Outcome | Result | p-value |
|---|---|---|
| PRIMARY Difference of Pain Scores on the Visual Analog Scale |
5.88; 4.85 | <0.05 sig |
| SECONDARY Subgroups |
— | — |
| SECONDARY Side Effects |
— | — |
| SECONDARY Mobilisation |
— | — |
| SECONDARY Costs |
— | — |
Summary
The purpose of this study is to investigate adequate pain treatment for patients after cesarean. In this study oral opioids were compared to intravenous opioids as they are supposed to provide superior pain control.
Eligibility Criteria
Study participation was offered to all pts. aged > 18 years in labor and delivery for elective or unplanned secondary cesarean in the 37th or higher week of gestation.
Inclusion Criteria
- cesarean in spinal anesthesia,
- no history of opioid or metamizol treatment
- written consent
- ability to use a Patient-controlled analgesia device
Exclusion Criteria
- cesarean in general anaesthesia
- use of peridural catheter for pre-, peri- or post cesarean analgesia
- additional post cesarean metamizol use
- allergy/hypersensitivity to morphine, oxycodon, acetaminophen or ibuprofen
- chronic use of general anaesthesia
- history of known pain syndrome
Data sourced from ClinicalTrials.gov (NCT01115101). 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.