Pain After Cesarean Section - A Danish Multicenter Cohort Study.

Last updated: June 10, 2024
Sponsor: Nordsjaellands Hospital
Overall Status: Completed

Phase

N/A

Condition

Pain

Treatment

Questionnaire

Clinical Study ID

NCT06012747
100
  • Ages 18-50
  • Female

Study 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

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

Exclusion Criteria:

Age < 18 years

Study Design

Total Participants: 752
Treatment Group(s): 1
Primary Treatment: Questionnaire
Phase:
Study Start date:
September 01, 2023
Estimated Completion Date:
May 31, 2024

Connect with a study center

  • Aalborg University Hospital

    Aalborg,
    Denmark

    Active - Recruiting

  • Department of Anesthesia, Aalborg University Hospital

    Aalborg,
    Denmark

    Site Not Available

  • Department of Anesthesia, Århus University Hospital

    Aarhus,
    Denmark

    Site Not Available

  • Århus University Hospital

    Aarhus,
    Denmark

    Active - Recruiting

  • Copenhagen University Hospital, Rigshospitalet

    Copenhagen,
    Denmark

    Active - Recruiting

  • Department of Anesthesia, Copenhagen University Hospital, Rigshospitalet

    Copenhagen,
    Denmark

    Site Not Available

  • Department of Anesthesia, Esbjerg Hospital

    Esbjerg,
    Denmark

    Site Not Available

  • Esbjerg Sygehus

    Esbjerg,
    Denmark

    Active - Recruiting

  • Department of Anesthesia, Gødstrup Hospital

    Gødstrup,
    Denmark

    Site Not Available

  • Department of Anesthesiology, Copenhagen University Hospital, Herlev

    Herlev,
    Denmark

    Site Not Available

  • Herlev Hospital

    Herlev,
    Denmark

    Active - Recruiting

  • Copenhagen University Hospital

    Hillerød, 3400
    Denmark

    Active - Recruiting

  • Department of Anesthesiology, Copenhagen University Hospital, North Zealand Hillerød

    Hillerød, 3400
    Denmark

    Site Not Available

  • Department of Anesthesia, Hjørring Sygehus

    Hjørring,
    Denmark

    Site Not Available

  • Hjørring Sygehus

    Hjørring,
    Denmark

    Active - Recruiting

  • Department of Anesthesia, Holbæk Hospital

    Holbæk,
    Denmark

    Site Not Available

  • Holbæk Hospital

    Holbæk,
    Denmark

    Active - Recruiting

  • Department of Anesthesia, Horsens Hospital

    Horsens,
    Denmark

    Site Not Available

  • Horsens Sygehus

    Horsens,
    Denmark

    Active - Recruiting

  • Department of Anesthesiology, Copenhagen university Hospital, Hvidovre

    Hvidovre,
    Denmark

    Site Not Available

  • Department of Anesthesia and Intensive care, University Hospital of Southern Denmark, Kolding

    Kolding,
    Denmark

    Site Not Available

  • Department of Anesthesia, Nykøbing Falster Hospital

    Nykøbing Falster,
    Denmark

    Site Not Available

  • Nykøbing Falster Hospital

    Nykøbing Falster,
    Denmark

    Active - Recruiting

  • Department of Anesthesia, Odense University Hospital

    Odense,
    Denmark

    Site Not Available

  • Odense University Hospital

    Odense,
    Denmark

    Active - Recruiting

  • Department of anesthesia, Randers Sygehus

    Randers,
    Denmark

    Site Not Available

  • Department of Anesthesia, Zealand University Hospital, Roskilde

    Roskilde,
    Denmark

    Site Not Available

  • Roskilde Sygehus

    Roskilde,
    Denmark

    Active - Recruiting

  • Department of Anesthesia, Slagelse Hospital

    Slagelse,
    Denmark

    Site Not Available

  • Slagelse Hospital

    Slagelse,
    Denmark

    Active - Recruiting

  • Department of Anesthesia,Viborg, Regional Hospital

    Viborg,
    Denmark

    Site Not Available

  • Viborg, Regional Hospital

    Viborg,
    Denmark

    Active - Recruiting

  • Department of Anesthesia, Åbenrå Hospital

    Åbenrå,
    Denmark

    Site Not Available

  • Åbenrå Sygehus

    Åbenrå,
    Denmark

    Active - Recruiting

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