NCT07134179

Insufficient Regional Anesthesia for Cesarean Section: Mothers' Experiences A Qualitative Study

Not yet recruiting Last updated 21 August 2025

What this trial tests

trial testing Experience of pain during caesarean delivery in Caesarean Section in 20 participants. Not yet recruiting.

Timeline

15 August 2025

Primary endpoint
1 April 2026

1 April 2026

Quick facts

Lead sponsor	Sygehus Lillebaelt
Status	Not yet recruiting
Study type	OBSERVATIONAL
Enrollment	20
Start date	15 August 2025
Primary completion	1 April 2026
Estimated completion	1 April 2026

Drugs / interventions tested

• Experience of pain during caesarean delivery

Conditions studied

• Caesarean Section — all drugs for Caesarean Section →
• Regional Anesthesia — all drugs for Regional Anesthesia →

Sponsor

Sygehus Lillebaelt — full company profile →

Who can join

18 and older, female only, with Caesarean Section or Regional Anesthesia. Patients with the condition only — healthy volunteers not accepted.

Sponsor's own description

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. 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 further intervention or ultimately a change in anesthetic form. If inadequate anesthesia is detected before the surgery begins, one may choose to administer renewed regional anesthesia (typically an epidural). However, if the woman first experiences pain after the surgery has commenced, it can be 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.

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.

The aim of this study is to investigate how women experience insufficient regional anesthesia during cesarean sections, in cases where the regional anesthesia was not converted to general anesthesia. The focus is on exploring the factors that contribute positively and negatively to the woman's experience in this situation, and investigate if any recommendations for how to handle the situation can be extrapolated from the women's experiences.

Method Qualitative study.

Inclusion criteria:

* Adult women undergoing elective or emergency cesarean delivery within the last 2 years, with the experience of pain during surgery
* Regional (spinal or epidural or combined epidural-spinal) anesthesia NOT converted to general anesthesia

Exclusion criteria:

* Does not speak Danish or English
* Does not wish to participate

Relevant women will be invited to contact us through public post on social media. If a woman responds to the post, she will be offered further information about the project, both verbally via telephone and in writing sent by email.

Women can also be invited to participate if encountered by a project-group member during clinical work.

Participants will be invited to an interview via telephone. 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.

Interviews will be recorded digitally and transcribed verbatim. The interview guide will be developed with input from the entire project group and with participation from three mothers who have previously experienced insufficient regional anesthesia during a cesarean section. The guide will be pilot-tested on 2-3 patients after cesarean section. The interview guide may be adjusted during the study, if necessary.

The number of women required to participate before a sufficient amount of information is obtained (as no new information is expected from subsequent interviews) is not known in advance; however, it is estimated that 20 women will need to participate. However, the sample size is also defined by convenience, as the investigators do not know how many women it will be possible to establish contact with via the Facebook post and through clinical work. If too few women (e.g. \<15) are included within the first two months, the investigators will make a new public posting and expand the period of inclusion to concern cesarean sections within the last 5 years instead of 2 years.

Baseline data regarding the mother and the cesarean section will be collected by asking the women during the scheduled interview, and therefore access to medical records are not necessary. Qualitative data will also be gathered through the interview, conducted as a semi-structured interview based on an interview guide.

Data will be entered into SurveyXact software, where it will be securely stored. Data will be handled using descriptive statistics. Interview data will be analyzed using content analysis. Nvivo software will be used for managing and coding qualitative data.

Publications & conference data

No peer-reviewed publications indexed yet for this trial.