Pain After Cesarean Section - A Danish Multicenter Cohort Study.
NCT ID: NCT06012747
Last Updated: 2024-06-11
Study Results
The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.
Basic Information
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COMPLETED
752 participants
OBSERVATIONAL
2023-09-01
2024-05-31
Brief Summary
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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.
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Detailed Description
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Conditions
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Study Design
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COHORT
PROSPECTIVE
Interventions
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Questionnaire
The patients receive a questionnaire every 6 hours during the first 24 hours after their cesarean section, and again after 2, 7, and 30 days.
Eligibility Criteria
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Exclusion Criteria
18 Years
50 Years
FEMALE
No
Sponsors
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Nordsjaellands Hospital
OTHER
Responsible Party
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Patricia Duch
MD Patricia Duch
Principal Investigators
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Patricia Duch, MD
Role: PRINCIPAL_INVESTIGATOR
Hillerod Hospital, Denmark
Helene Nedergaard, MD, Ph.D
Role: STUDY_CHAIR
Kolding Sygehus
Locations
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Department of Anesthesia, Åbenrå Hospital
Aabenraa, , Denmark
Department of Anesthesia, Aalborg University Hospital
Aalborg, , Denmark
Department of Anesthesia, Århus University Hospital
Aarhus, , Denmark
Department of Anesthesia, Copenhagen University Hospital, Rigshospitalet
Copenhagen, , Denmark
Department of Anesthesia, Esbjerg Hospital
Esbjerg, , Denmark
Department of Anesthesia, Gødstrup Hospital
Gødstrup, , Denmark
Department of Anesthesiology, Copenhagen University Hospital, Herlev
Herlev, , Denmark
Department of Anesthesiology, Copenhagen University Hospital, North Zealand Hillerød
Hillerød, , Denmark
Department of Anesthesia, Hjørring Sygehus
Hjørring, , Denmark
Department of Anesthesia, Holbæk Hospital
Holbæk, , Denmark
Department of Anesthesia, Horsens Hospital
Horsens, , Denmark
Department of Anesthesiology, Copenhagen university Hospital, Hvidovre
Hvidovre, , Denmark
Department of Anesthesia and Intensive care, University Hospital of Southern Denmark, Kolding
Kolding, , Denmark
Department of Anesthesia, Nykøbing Falster Hospital
Nykøbing Falster, , Denmark
Department of Anesthesia, Odense University Hospital
Odense, , Denmark
Department of anesthesia, Randers Sygehus
Randers, , Denmark
Department of Anesthesia, Zealand University Hospital, Roskilde
Roskilde, , Denmark
Department of Anesthesia, Slagelse Hospital
Slagelse, , Denmark
Department of Anesthesia,Viborg, Regional Hospital
Viborg, , Denmark
Countries
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References
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Duch P, Wikkelso A, Jorgensen CC, Jakobsen JC, Mathiesen O, Norskov AK, Nedergaard H; on the behalf of the National Pain after Cesarean Section (PACS) Working Group . And in collaboration with CEPRA a consortium initiative for peri-operative research (www.cepra.nu). Pain and adverse effects after caesarean delivery: A nationwide prospective cohort study. Eur J Anaesthesiol. 2025 Sep 15. doi: 10.1097/EJA.0000000000002277. Online ahead of print.
Provided Documents
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Document Type: Study Protocol
Other Identifiers
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100
Identifier Type: -
Identifier Source: org_study_id
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