Pain After Cesarean Section - A Danish Multicenter Cohort Study.

Pain Clinical Trial

Official title:

Pain After Cesarean Section - A Danish Multicenter Cohort Study.

Clinical Trial Details — Status: Recruiting

Administrative data

• NCT number: NCT06012747
• Other study ID #: 100
• Status: Recruiting
• Start date: September 1, 2023
• Est. completion date: December 31, 2025

Study information

• Verified date: March 2024
• Source: Nordsjaellands Hospital
• Contact: Patricia Duch, MD
• Phone: 0045 48292504
• Email: patricia.duch[@]regioh.dk
• Is FDA regulated: No
• Study type: Observational

Clinical Trial 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.

Recruitment information / eligibility

• Status: Recruiting
• Enrollment: 500
• Est. completion date: December 31, 2025
• Est. primary completion date: December 31, 2024
• Gender: Female
• Age group: 18 Years to 50 Years

Eligibility

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

Related Conditions & MeSH terms

• Cesarean Section
• Pain
• Recovery

Intervention

Other:
• 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.

Locations

Country	Name	City	State
Denmark	Department of Anesthesia, Aalborg University Hospital	Aalborg
Denmark	Department of Anesthesia, Århus University Hospital	Aarhus
Denmark	Department of Anesthesia, Åbenrå Hospital	Åbenrå
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

Sponsors (1)

Lead Sponsor	Collaborator
Nordsjaellands Hospital

Country where clinical trial is conducted

Denmark, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Self reported pain on movement from supine position to sitting position after 24 hours, NRS 0-10	Patient reported	24 hours after cesarean section
Primary	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.	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.	24 hours after cesarean section
Primary	Neonatal admission ,	yes/no	within 24 hours
Secondary	See protokol for the multible secondary and exploratory outcomes	See protokol for the multible secondary and exploratory outcomes	0-30 days