Pain After Cesarean Section - A Danish Multicenter Cohort Study.

NCT06012747 | Completed DMC

• 1 other identifier: 100
• Study Type: observational
• Target: 752
• Locations: 1 country
• Sites: 19

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.

Conditions

Pain; Cesarean Section; Recovery

Keywords

Pain; Cesarean Section; Recovery; REDCap

Outcome Measures

Primary Outcomes (3)

• 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 Outcomes (1)

• See protokol for the multible secondary and exploratory outcomes

  0-30 days

Interventions

Questionnaire OTHER

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.

Eligibility Criteria

• Age: 18 Years - 50 Years
• Sex: female
• Age Groups: Adult (18-64)
• Sampling Method: Non-Probability Sample

Study Population

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

You may not qualify if:

• Age \< 18 years

Sponsors & Collaborators

• Nordsjaellands Hospital: lead

Study Sites (19)

Department of Anesthesia, Åbenrå Hospital

Aabenraa, Denmark

Location

Department of Anesthesia, Aalborg University Hospital

Aalborg, Denmark

Location

Department of Anesthesia, Århus University Hospital

Aarhus, Denmark

Location

Department of Anesthesia, Copenhagen University Hospital, Rigshospitalet

Copenhagen, Denmark

Location

Department of Anesthesia, Esbjerg Hospital

Esbjerg, Denmark

Location

Department of Anesthesia, Gødstrup Hospital

Gødstrup, Denmark

Location

Department of Anesthesiology, Copenhagen University Hospital, Herlev

Herlev, Denmark

Location

Department of Anesthesiology, Copenhagen University Hospital, North Zealand Hillerød

Hillerød, 3400, Denmark

Location

Department of Anesthesia, Hjørring Sygehus

Hjørring, Denmark

Location

Department of Anesthesia, Holbæk Hospital

Holbæk, Denmark

Location

Department of Anesthesia, Horsens Hospital

Horsens, Denmark

Location

Department of Anesthesiology, Copenhagen university Hospital, Hvidovre

Hvidovre, Denmark

Location

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

Kolding, Denmark

Location

Department of Anesthesia, Nykøbing Falster Hospital

Nykøbing Falster, Denmark

Location

Department of Anesthesia, Odense University Hospital

Odense, Denmark

Location

Department of anesthesia, Randers Sygehus

Randers, Denmark

Location

Department of Anesthesia, Zealand University Hospital, Roskilde

Roskilde, Denmark

Location

Department of Anesthesia, Slagelse Hospital

Slagelse, Denmark

Location

Department of Anesthesia,Viborg, Regional Hospital

Viborg, Denmark

Location

Related Publications (1)

• Duch P, Wikkelso A, Jorgensen CC, Jakobsen JC, Mathiesen O, Norskov AK, Nedergaard H; on the behalf of the National Pain after Cesarean Section (PACS) Working Group . And in collaboration with CEPRA a consortium initiative for peri-operative research (www.cepra.nu). Pain and adverse effects after caesarean delivery: A nationwide prospective cohort study. Eur J Anaesthesiol. 2026 Jan 1;43(1):34-44. doi: 10.1097/EJA.0000000000002277. Epub 2025 Sep 22.

  PMID: 40956058 DERIVED

MeSH Terms

Conditions

Pain

Interventions

Surveys and Questionnaires

Condition Hierarchy (Ancestors)

Neurologic Manifestations; Signs and Symptoms; Pathological Conditions, Signs and Symptoms

Intervention Hierarchy (Ancestors)

Data Collection; Epidemiologic Methods; Investigative Techniques; Health Care Evaluation Mechanisms; Quality of Health Care; Health Care Quality, Access, and Evaluation; Public Health; Environment and Public Health

Study Officials

• Patricia Duch, MD

  Hillerod Hospital, Denmark

  PRINCIPAL INVESTIGATOR

• Helene Nedergaard, MD, Ph.D

  Kolding Sygehus

  STUDY CHAIR

Study Design

• Study Type: observational
• Observational Model: COHORT
• Time Perspective: PROSPECTIVE
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: MD Patricia Duch

Study Record Dates

• First Submitted: May 10, 2023
• First Posted: August 25, 2023
• Study Start: September 1, 2023
• Primary Completion: May 31, 2024
• Study Completion: May 31, 2024
• Last Updated: June 11, 2024

Record last verified: 2024-06

Locations

DK (19)