N/A
N=69
High Pain Intervention in Cesarean Sections
Other Chronic Postoperative Pain
Bottom Line
View on ClinicalTrials.gov: NCT01298778 ↗Enrolled (actual)
69
Serious AEs
0.0%
Results posted
Jun 2017
Primary outcome: Primary: Severity of Acute Pain — 46; 31 mm — p=0.05
Study Design & Population
- Study type
- Interventional
- Phase
- N/A
- Interventions
- Duramorph 150 (Drug); Acetaminophen (Drug); Duramorph 300 (Drug)
- Age
- Adult · 18+ yrs
- Sex
- Female
- Sponsor
- Wake Forest University Health Sciences
- Primary completion
- Jul 2011
Outcome Measures
| Outcome | Result | p-value |
|---|---|---|
| PRIMARY Severity of Acute Pain |
46; 31 | 0.05 |
| SECONDARY Incidence of Persistent Pain |
13; 10 | — |
| SECONDARY Pain |
19; 4; 69; 62 | — |
| SECONDARY Analgesic Consumption |
15; 15; 21; 15 | — |
| SECONDARY Incidence of Depression |
3; 4 | — |
| SECONDARY Average Pain Over 24 Hours |
37; 23 | — |
Summary
In previous studies the investigators have seen that the severity of pain one day after cesarean delivery can predict the presence of pain and depression 2 months later. The investigators believe those at risk for severe acute post-partum pain can be identified, and medical interventions can be tailored to manage postoperative pain more effectively.
Eligibility Criteria
Inclusion Criteria
- elective cesarean section
- age >/= 18 years old
- not allergic proposed study medications
- predicted to experience high pain postop based on preoperative evaluation
Exclusion Criteria
- allergy to study medications
- known hepatic disease
- weight > 300 lbs
Data sourced from ClinicalTrials.gov (NCT01298778). 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.