Insufficient Regional Anesthesia and Conversion to General Anesthesia for Cesarean Section A Qualitative Multicenter Study
NCT06669156 · Status: RECRUITING · Type: OBSERVATIONAL · Enrollment: 30
Last updated 2025-08-27
Summary
Background In Denmark, approximately 20% of all children are born via cesarean section (C-section), making it the most common surgical procedure (also internationally). The recommended anesthesia for cesarean sections is regional anesthesia (spinal or epidural, "spinal anesthesia"), as it has several advantages: the woman is awake and experiences the delivery of her child, she maintains spontaneous breathing (the risk of difficult airway management is significantly higher in pregnant women), and the risk of aspiration of stomach contents into the lungs (which is clearly increased in pregnant women) is reduced. Furthermore, regional anesthesia can contribute to early postoperative pain management to some extent.
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.
Conditions
- Cesarean Section Complications
- Cesarean Section Pain
- Regional Anesthesia
Sponsors & Collaborators
-
University Hospital of North Zealand
collaborator UNKNOWN -
Copenhagen University Hospital at Herlev
collaborator OTHER -
Aalborg University Hospital
collaborator OTHER -
Copenhagen University Hospital, Denmark
collaborator OTHER -
Zealand University Hospital
collaborator OTHER -
Sygehus Lillebaelt
lead OTHER
Eligibility
- Min Age
- 18 Years
- Sex
- FEMALE
- Healthy Volunteers
- No
Timeline & Regulatory
- Start
- 2025-02-01
- Primary Completion
- 2026-02-01
- Completion
- 2027-01-01
Countries
- Denmark
Study Locations
More Related Trials
-
Mothers' Experience of Category 1 Cesarean Section
NCT05840367 ·Status: RECRUITING
-
Combined Spinal-epidural Versus Spinal Analgesia for Elective Caesarean Section in the Postoperative Period
NCT02273011 ·Status: COMPLETED
-
General or Spinal Anesthesia for Cesarean Delivery
NCT05727449 ·Status: COMPLETED
-
Pain After Cesarean Section - A Danish Multicenter Cohort Study.
NCT06012747 ·Status: COMPLETED
-
Influence of Surgical Regional Anesthesia on Postoperative Pain
NCT01234662 ·Status: UNKNOWN ·Phase: NA
-
Factors Associated With Failed Spinal Anesthesia for Cesarean Delivery
NCT04685980 ·Status: COMPLETED
-
A 5-Year Anesthetic Evaluation of Cases Undergoing Cesarean Section Delivery ın Our Clinic
NCT06524713 ·Status: ACTIVE_NOT_RECRUITING
-
Preoperative Epidural Labor Analgesia and Postoperative Pain
NCT03381690 ·Status: COMPLETED
-
Anesthetic Considerations for Repeat Cesarean Section - a Prospective Study
NCT04693572 ·Status: UNKNOWN
-
The Effect of Different Altitude Levels on Spinal Anesthesia in Cesarean Section Surgery
NCT05715476 ·Status: COMPLETED ·Phase: NA
-
Timing of Planned Caesarean Section and Morbidity of the Newborn
NCT00835003 ·Status: COMPLETED ·Phase: NA
-
Preoperative Data and the Spinal Spread of Local Anesthetic in Cesarean Section
NCT07197398 ·Status: RECRUITING
-
Neonatal Evaluation of Norepinephrine Infusion in Spinal Anesthesia for Cesarean Section
NCT04245891 ·Status: COMPLETED
-
Infiltration Analgesia After Caesarean Section
NCT01094106 ·Status: COMPLETED ·Phase: PHASE4
-
Continuous Infusion for Pain Relief
NCT02711072 ·Status: UNKNOWN ·Phase: NA
-
Pharmacogenetics of Remifentanil in Patients With Hypertension Undergoing Cesarean Delivery Under General Anesthesia
NCT01550640 ·Status: COMPLETED ·Phase: NA
-
Optimal Site of Administration for Continuous Wound Infusion After Cesarean Section
NCT01160913 ·Status: COMPLETED ·Phase: PHASE3
-
Evaluation of Copeptin Levels in Elective Cesarean Section With Different Anesthetic Technique
NCT03536910 ·Status: COMPLETED ·Phase: NA
-
How Fast Are we? Speed of General Versus Spinal Anesthesia for Emergency Cesarean Delivery: A Simulation Based Study
NCT00966680 ·Status: COMPLETED
-
The Patient AS EDUcator in Anesthesia: Exploring the Patients' Experience During and After Unexpected Cesarean Delivery Under General Anesthesia to Inform Anesthetic Practice
NCT06589661 ·Status: COMPLETED
-
Effects of Intraoperative Oxygen Therapy on Oxygenation of Newborns Born Via Elective Cesarian Section
NCT02804555 ·Status: COMPLETED ·Phase: NA
-
Low Dose Spinal Anesthesia in Cesarean Surgery
NCT02563795 ·Status: COMPLETED
-
Prediction of Postoperative Pain by an Electrical Pain Stimulus
NCT00374504 ·Status: COMPLETED
-
Impact of a Strategy Combining Morphine Savings and Anesthesia Technique on the Quality of Post-operative Rehabilitation
NCT04377984 ·Status: TERMINATED
-
General Anesthesia for Cesarean Section, Maternal and Perinatal Outcomes
NCT06160583 ·Status: COMPLETED