Actively Recruiting
Insufficient Regional Anesthesia and Conversion to General Anesthesia for Cesarean Section A Qualitative Multicenter Study
Led by Sygehus Lillebaelt · Updated on 2025-08-27
30
Participants Needed
7
Research Sites
47 weeks
Total Duration
On this page
Sponsors
S
Sygehus Lillebaelt
Lead Sponsor
U
University Hospital of North Zealand
Collaborating Sponsor
AI-Summary
What this Trial Is About
In Denmark, about 20% of all children are born by cesarean section, which is the most common surgical procedure. The recommended anesthesia method is regional anesthesia, such as spinal or epidural, because it allows the mother to be awake and reduces certain risks. However, some women experience pain during the procedure due to insufficient anesthesia, sometimes requiring conversion to general anesthesia. This study aims to explore how women experience this conversion and the factors affecting their experience after cesarean sections with inadequate regional anesthesia. The study involves women who have undergone elective or emergency cesarean sections where regional anesthesia was switched to general anesthesia during the operation due to insufficient pain relief. Women will be invited to participate shortly after their cesarean section before hospital discharge. The study will include all such cases from six Danish hospitals over one year. Participants will have a follow-up telephone interview three months after surgery, including a screening for post-traumatic stress. During the study, women will first be contacted within one or two days after their cesarean section to invite them to participate. Those who agree will be interviewed by phone about their experiences three months later, with the interviews recorded and transcribed for analysis. Researchers will assess their experience of insufficient anesthesia and screen for post-traumatic stress symptoms. The study focuses on understanding the emotional and psychological impact of anesthesia conversion during cesarean delivery.
CONDITIONS
Brief Title
Insufficient Regional Anesthesia and Conversion to General Anesthesia for Cesarean Section A Qualitative Multicenter Study
Who Can Participate
Eligibility Criteria
You may qualify if you...
- Women undergoing elective or emergency cesarean section, aged over 17 years
- Regional (spinal or epidural or combined epidural-spinal) anesthesia converted to general anesthesia intraoperatively due to insufficient regional anesthesia (not for obstetric indications)
You will not qualify if you...
- Does not speak Danish or English
- Does not wish to participate
AI-Screening
AI-Powered Screening
Complete this quick 3-step screening to check your eligibility
Your Study Journey
Duration - Up to 1 year
Participants are screened for eligibility to participate in the trial.
Duration - 3 months after cesarean section
Participants who experience conversion from regional to general anesthesia during cesarean section are observed.
1 visit approximately 3 months after cesarean section
Trial Site Locations
Total: 7 locations
1
Viborg Hospital
Viborg, Region Midt, Denmark
Actively Recruiting
2
Aalborg Hospital
Aalborg, Denmark, 9000
Actively Recruiting
3
Rigshospitalet, Copenhagen University Hospital
Copenhagen, Denmark
Actively Recruiting
4
Herlev Hospital
Herlev, Denmark
Actively Recruiting
5
Hillerød Hospital
Hillerød, Denmark, 3400
Actively Recruiting
6
Lillebaelt Hospital, Kolding
Kolding, Denmark, 6000
Actively Recruiting
7
Roskilde Hospital
Roskilde, Denmark, 4000
Actively Recruiting
Research Team
H
Helene K Nedergaard, MD, PhD
How is the study designed?
Study Type
OBSERVATIONAL
Masking
N/A
Allocation
N/A
Model
N/A
Primary Purpose
N/A
Number of Arms
1
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