Pain After Cesarean Section - A Danish Multicenter Cohort Study.

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.

Study Overview

• Status: Completed
• Conditions: Pain; Recovery; Cesarean Section
• Intervention / Treatment: Other: Questionnaire

• Study Type: Observational
• Enrollment (Actual): 752

Contacts and Locations

Study Locations

• Denmark
  • Aalborg, Denmark
    • Department of Anesthesia, Aalborg University Hospital
  • Aarhus, Denmark
    • Department of Anesthesia, Århus University Hospital
  • Copenhagen, Denmark
    • Department of Anesthesia, Copenhagen University Hospital, Rigshospitalet
  • Esbjerg, Denmark
    • Department of Anesthesia, Esbjerg Hospital
  • Gødstrup, Denmark
    • Department of Anesthesia, Gødstrup Hospital
  • Herlev, Denmark
    • Department of Anesthesiology, Copenhagen University Hospital, Herlev
  • Hillerød, Denmark, 3400
    • Department of Anesthesiology, Copenhagen University Hospital, North Zealand Hillerød
  • Hjørring, Denmark
    • Department of Anesthesia, Hjørring Sygehus
  • Holbæk, Denmark
    • Department of Anesthesia, Holbæk Hospital
  • Horsens, Denmark
    • Department of Anesthesia, Horsens Hospital
  • Hvidovre, Denmark
    • Department of Anesthesiology, Copenhagen university Hospital, Hvidovre
  • Kolding, Denmark
    • Department of Anesthesia and Intensive care, University Hospital of Southern Denmark, Kolding
  • Nykøbing Falster, Denmark
    • Department of Anesthesia, Nykøbing Falster Hospital
  • Odense, Denmark
    • Department of Anesthesia, Odense University Hospital
  • Randers, Denmark
    • Department of anesthesia, Randers Sygehus
  • Roskilde, Denmark
    • Department of Anesthesia, Zealand University Hospital, Roskilde
  • Slagelse, Denmark
    • Department of Anesthesia, Slagelse Hospital
  • Viborg, Denmark
    • Department of Anesthesia,Viborg, Regional Hospital
  • Åbenrå, Denmark
    • Department of Anesthesia, Åbenrå Hospital

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: Adult
• Accepts Healthy Volunteers: N/A

• Sampling Method: Non-Probability Sample

Study Population

Danish patients > 18 years old who undergo planned cesarean section under spinal anesthesia

Description

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

Study Plan

How is the study designed?

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Self reported pain on movement from supine position to sitting position after 24 hours, NRS 0-10	Patient reported	24 hours after cesarean section
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
Neonatal admission ,	yes/no	within 24 hours

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
See protokol for the multible secondary and exploratory outcomes	See protokol for the multible secondary and exploratory outcomes	0-30 days

Collaborators and Investigators

• Sponsor: Nordsjaellands Hospital
• Investigators: Principal Investigator: Patricia Duch, MD, Hillerod Hospital, Denmark; Study Chair: Helene Nedergaard, MD, Ph.D, Kolding Sygehus

Study record dates

Study Major Dates

• Study Start (Actual): September 1, 2023
• Primary Completion (Actual): May 31, 2024
• Study Completion (Actual): May 31, 2024

Study Registration Dates

• First Submitted: May 10, 2023
• First Submitted That Met QC Criteria: August 22, 2023
• First Posted (Actual): August 25, 2023

Study Record Updates

• Last Update Posted (Actual): June 11, 2024
• Last Update Submitted That Met QC Criteria: June 10, 2024
• Last Verified: June 1, 2024

More Information

Terms related to this study

• Keywords: Pain; Recovery; Cesarean Section; REDCap
• Other Study ID Numbers: 100

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: UNDECIDED
• IPD Plan Description: Each participating site has access to the data, which can be viewed by the project managers. Once all the data is collected, it will be anonymized and used for calculations. After the data is published, each participating site can have control over its own data but can only publish it with the permission of the project managers.

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No