Actively Recruiting

Age: 18Years +
FEMALE
ID06669156

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

Age: 18Years +
FEMALE

Eligibility Criteria

Eligible

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)
Not Eligible

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

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Your Study Journey

Screening

Duration - Up to 1 year

Participants are screened for eligibility to participate in the trial.

Observational Monitoring

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

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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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