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Clinical Trial Details — Status: Completed

Administrative data

NCT number NCT06012747
Other study ID # 100
Secondary ID
Status Completed
Phase
First received
Last updated
Start date September 1, 2023
Est. completion date May 31, 2024

Study information

Verified date June 2024
Source Nordsjaellands Hospital
Contact n/a
Is FDA regulated No
Health authority
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 Completed
Enrollment 752
Est. completion date May 31, 2024
Est. primary completion date May 31, 2024
Accepts healthy volunteers
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

Study Design


Related Conditions & MeSH terms


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
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