Clinical trial NCT06012747: Pain After Cesarean Section - A Danish Multicenter Cohort Study.
Official title: Pain After Cesarean Section - A Danish Multicenter Cohort Study.
Study type: OBSERVATIONAL
Overall status: COMPLETED
Conditions: Pain
Cesarean Section
Recovery
Keywords: Pain
Cesarean Section
Recovery
REDCap
Lead sponsor: Nordsjaellands Hospital
Sponsor class: OTHER
First posted: 2023-08-25
Enrollment: 752
Sex: FEMALE
Minimum age (years): 18
Maximum age (years): 50
Standard ages: ADULT
Observational model: COHORT
Time perspective: PROSPECTIVE
Sampling method: NON_PROBABILITY_SAMPLE
Study population: Danish patients \> 18 years old who undergo planned cesarean section under spinal anesthesia

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.


Eligibility 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

Primary outcomes:
measure: Self reported pain on movement from supine position to sitting position after 24 hours, NRS 0-10
timeFrame: 24 hours after cesarean section
measure: 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.
timeFrame: 24 hours after cesarean section
measure: Neonatal admission ,
timeFrame: within 24 hours
Secondary outcomes:
measure: See protokol for the multible secondary and exploratory outcomes
timeFrame: 0-30 days
Other outcomes:
Locations:
city: Aalborg
country: Denmark
facility: Department of Anesthesia, Aalborg University Hospital
city: Aarhus
country: Denmark
facility: Department of Anesthesia, Århus University Hospital
city: Copenhagen
country: Denmark
facility: Department of Anesthesia, Copenhagen University Hospital, Rigshospitalet
city: Esbjerg
country: Denmark
facility: Department of Anesthesia, Esbjerg Hospital
city: Gødstrup
country: Denmark
facility: Department of Anesthesia, Gødstrup Hospital
city: Herlev
country: Denmark
facility: Department of Anesthesiology, Copenhagen University Hospital, Herlev
city: Hillerød
country: Denmark
facility: Department of Anesthesiology, Copenhagen University Hospital, North Zealand Hillerød
city: Hjørring
country: Denmark
facility: Department of Anesthesia, Hjørring Sygehus
city: Holbæk
country: Denmark
facility: Department of Anesthesia, Holbæk Hospital
city: Horsens
country: Denmark
facility: Department of Anesthesia, Horsens Hospital
city: Hvidovre
country: Denmark
facility: Department of Anesthesiology, Copenhagen university Hospital, Hvidovre
city: Kolding
country: Denmark
facility: Department of Anesthesia and Intensive care, University Hospital of Southern Denmark, Kolding
city: Nykøbing Falster
country: Denmark
facility: Department of Anesthesia, Nykøbing Falster Hospital
city: Odense
country: Denmark
facility: Department of Anesthesia, Odense University Hospital
city: Randers
country: Denmark
facility: Department of anesthesia, Randers Sygehus
city: Roskilde
country: Denmark
facility: Department of Anesthesia, Zealand University Hospital, Roskilde
city: Slagelse
country: Denmark
facility: Department of Anesthesia, Slagelse Hospital
city: Viborg
country: Denmark
facility: Department of Anesthesia,Viborg, Regional Hospital
city: Åbenrå
country: Denmark
facility: Department of Anesthesia, Åbenrå Hospital
Study officials:
affiliation: Hillerod Hospital, Denmark
name: Patricia Duch, MD
role: PRINCIPAL_INVESTIGATOR
affiliation: Kolding Sygehus
name: Helene Nedergaard, MD, Ph.D
role: STUDY_CHAIR
References: