Insufficient Regional Anesthesia and Conversion to General Anesthesia for Cesarean Section A Qualitative Multicenter Study
NCT ID: NCT06669156
Last Updated: 2025-08-27
Study Results
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Basic Information
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RECRUITING
30 participants
OBSERVATIONAL
2025-02-01
2027-01-01
Brief Summary
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With spinal anesthesia, most women feel pressure and touch but no pain during the cesarean section. However, some women do experience pain during the procedure, necessitating a change in the plan. If inadequate anesthesia is detected before the surgery begins, one may choose (depending on, for example, the urgency of the cesarean) to administer renewed regional anesthesia (typically an epidural). However, if the woman first experiences pain after the surgery has commenced, it is necessary to place her under general anesthesia for the remainder of the procedure. Experience shows that this process can be challenging, and there are frequent examples in clinical practice of inappropriate courses of action, where women have experienced unacceptable pain during their cesarean sections without being placed under general anesthesia. It is difficult to obtain an exact figure on how many women experience inadequate anesthesia during cesarean sections under regional anesthesia, as not all cases are recognized or followed up on. Studies indicate that up to 12% experience pain during a cesarean section.
The consequences of inadequate anesthesia for cesarean sections can be quite significant for women, including impaired bonding with the child, poorer establishment of breastfeeding, increased risk of postpartum reactions and post-traumatic stress, as well as (anecdotally) the risk of women opting out of future pregnancies, as they may be reluctant to subject themselves to a similar situation again.
Aim The aim of this study is to investigate how women experience insufficient regional anesthesia during cesarean sections that require conversion to general anesthesia. The focus is on exploring the factors that contribute positively and negatively to the woman's experience in this situation.
Method Qualitative study in six Danish hospitals.
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
The woman will be contacted for the first time on day 1 or 2 after the cesarean section (before she is discharged from the hospital). She will be informed about the project and invited to participate. As a potential project participant, she is entitled to a 24-hour consideration period, and if desired, a new contact will be arranged for the following day. If she wishes to participate, she will be contacted again after 3 months. At this time, she will receive a call to schedule a follow-up telephone interview within a few days. This will take place as a semi-structured interview, initiated with open questions and concluded with a few more specific questions. At the end of the interview, a screening for post-traumatic stress will be conducted using the PTSD-8 tool. Follow-up interviews will be recorded digitally and transcribed verbatim.
Sample Size The project encompasses all women at the participating centers who experience insufficient regional anesthesia during a cesarean section and conversion to general anesthesia during 1 year.
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Detailed Description
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Conditions
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Study Design
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COHORT
PROSPECTIVE
Study Groups
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Partuients experiencing conversion of regional to general anesthesia for cesarean section
All parturients undergoing emergency or elective cesarean section in a participating hospital, who experience insufficient regional anesthesia and conversion to general anesthesia during the 1 year inclusion period
No interventions assigned to this group
Eligibility Criteria
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Inclusion Criteria
* 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 wish to participate
18 Years
FEMALE
No
Sponsors
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University Hospital of North Zealand
UNKNOWN
Copenhagen University Hospital at Herlev
OTHER
Aalborg University Hospital
OTHER
Copenhagen University Hospital, Denmark
OTHER
Zealand University Hospital
OTHER
Sygehus Lillebaelt
OTHER
Responsible Party
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Helene Korvenius Nedergaard
MD, PhD
Locations
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Viborg Hospital
Viborg, Region Midt, Denmark
Aalborg Hospital
Aalborg, , Denmark
Rigshospitalet, Copenhagen University Hospital
Copenhagen, , Denmark
Herlev Hospital
Herlev, , Denmark
Hillerød Hospital
Hillerød, , Denmark
Lillebaelt Hospital, Kolding
Kolding, , Denmark
Roskilde Hospital
Roskilde, , Denmark
Countries
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Central Contacts
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Facility Contacts
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Other Identifiers
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24/67884
Identifier Type: -
Identifier Source: org_study_id
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