Pain After Cesarean Section - A Danish Multicenter Cohort Study.
Study Details
Study Description
Brief Summary
Pain after a cesarean section is of moderate to severe intensity. A Danish multicenter study from 2021 used an obstetric Quality of Recovery score 24 hours after the cesarean section and found that 45% of 861 patients had experienced very severe pain during recovery.
This result was surprisingly high but also unspecific. Therefore, the investigators aim to investigate the intensity of pain experienced by patients at specific time intervals after the cesarean section e.g., every 6th hour. Additionally, the investigators will examine whether the pain has an impact on important functions for both the patients and the newborns, as well as assess the overall morphine consumption.
All Danish regions have approved the REDCap database as a secure way to collect and store data. REDCap can also send encrypted links that can be converted into SMS messages sent to the participants' mobile phones at fixed intervals, allowing participants to enter data directly into the secure system. The investigators also aim to feasibility test the system.
When a child is delivered by cesarean section, it is an expectation that the mother can take care of herself and the baby a few hours after the surgery. However, severe pain can hinder this. Therefore, it is important to investigate whether pain relief for our patients is sufficient.
Based on response rates and the frequency of outcomes, data from this observational study can support the design of a future national multicenter randomized controlled trial (RCT) with a focus on postoperative pain intervention. The incidences of binary outcome measures and standard deviations of continuous outcome measures will support the sample size calculations for our RCT.
| Condition or Disease | Intervention/Treatment | Phase |
|---|---|---|
|
Study Design
Outcome Measures
Primary Outcome Measures
- Self reported pain on movement from supine position to sitting position after 24 hours, NRS 0-10 [24 hours after cesarean section]
Patient reported
- Composite outcome of self reported morphine side effects occurring within 24 hours For vomiting and urinary retention, this is recorded as yes/no, where yes is considered a side effect. [24 hours after cesarean section]
consisting of either nausea, dizziness, itching, vomiting, or urinary retention. Nausea, itching, and dizziness are recorded on a 4-point scale: None, mild, moderate, severe. Where moderate and severe are considered side effects. For vomiting and urinary retention, this is recorded as yes/no, where yes is considered a side effect.
- Neonatal admission , [within 24 hours]
yes/no
Secondary Outcome Measures
- See protokol for the multible secondary and exploratory outcomes [0-30 days]
See protokol for the multible secondary and exploratory outcomes
Eligibility Criteria
Criteria
Inclusion Criteria Patients who undergo planned cesarean section under spinal anesthesia. Patients must be able to answer a Danish questionnaire via SMS on their phone and provide consent.
Exclusion Criteria:
Age < 18 years
Contacts and Locations
Locations
| Site | City | State | Country | Postal Code | |
|---|---|---|---|---|---|
| 1 | Copenhagen University Hospital | Hillerød | Denmark | 3400 |
Sponsors and Collaborators
- Nordsjaellands Hospital
Investigators
- Principal Investigator: Patricia Duch, MD, Hillerod Hospital, Denmark
- Study Chair: Helene Nedergaard, MD, Ph.D, Kolding Sygehus
Study Documents (Full-Text)
More Information
Publications
None provided.- 100