When spinal or epidural anesthesia is insufficient and a cesarean delivery is converted to general anesthesia
Insufficient Regional Anesthesia and Conversion to General Anesthesia for Cesarean Section A Qualitative Multicenter Study
Sygehus Lillebaelt · NCT06669156
This project will see how and why regional anesthesia sometimes fails and how women and clinical teams handle conversion to general anesthesia during cesarean delivery.
Quick facts
| Study type | Observational |
|---|---|
| Enrollment | 30 (estimated) |
| Ages | 18 Years and up |
| Sex | Female |
| Sponsor | Sygehus Lillebaelt (other) |
| Locations | 7 sites (Viborg, Region Midt and 6 other locations) |
| Trial ID | NCT06669156 on ClinicalTrials.gov |
What this trial studies
This is a multicenter qualitative observational project carried out at several Danish hospitals that collects information on cases where spinal, epidural, or combined spinal-epidural anesthesia is converted to general anesthesia after surgery has started. Researchers will gather clinical details and likely conduct interviews or structured debriefs with patients and clinical staff to capture experiences, decision-making, and sequence of events. The focus is on conversions that occur because the regional block proved insufficient, excluding conversions for obstetric indications. Findings will be used to identify common causes, communication issues, and opportunities to improve safety and patient experience.
Who should consider this trial
Good fit: Women over 17 years having elective or emergency cesarean delivery whose regional anesthesia is converted intraoperatively to general anesthesia and who speak Danish or English and consent to participate.
Not a fit: Women who did not experience intraoperative conversion, who were converted for obstetric extraction reasons, who are under 18, or who do not speak Danish or English are not eligible and would not benefit from these results directly.
Why it matters
Potential benefit: If successful, the findings could lead to better protocols, communication, and preparation that reduce the chance of unexpected pain or emergency conversions and improve patient experience and safety.
How similar studies have performed: Previous research has documented the incidence and risks of failed regional anesthesia in cesarean delivery, but multicenter qualitative work focusing on patient and clinician experiences of intraoperative conversion is relatively limited.
Eligibility criteria
Show full inclusion / exclusion criteria
Inclusion Criteria: * 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 (i.e., after surgery has commenced) due to insufficient regional anesthesia (i.e., not for obstetric indications, such as in cases of difficult fetal extraction) Exclusion Criteria: * Does not speak Danish or English * Does not wish to participate
Where this trial is running
Viborg, Region Midt and 6 other locations
- Viborg Hospital — Viborg, Region Midt, Denmark (RECRUITING)
- Aalborg Hospital — Aalborg, Denmark (RECRUITING)
- Rigshospitalet, Copenhagen University Hospital — Copenhagen, Denmark (RECRUITING)
- Herlev Hospital — Herlev, Denmark (RECRUITING)
- Hillerød Hospital — Hillerød, Denmark (RECRUITING)
- Lillebaelt Hospital, Kolding — Kolding, Denmark (RECRUITING)
- Roskilde Hospital — Roskilde, Denmark (RECRUITING)
Study contacts
- Study coordinator: Helene K Nedergaard, MD, PhD
- Email: helene.korvenius.nedergaard@rsyd.dk
- Phone: +4553272244
How to participate
- Review the eligibility criteria above with your treating physician.
- Visit the official trial page on ClinicalTrials.gov for the most current contact information and recruitment status.
- Contact the listed study coordinator or principal investigator to request pre-screening. Pre-screening is free and never obligates you to enroll.
Conditions: Cesarean Section Complications, Cesarean Section Pain, Regional Anesthesia