How common is intraoperative pain occur during caesarean delivery surgery when the patient is awake and what is the impact on mothers?
| ISRCTN | ISRCTN15269213 |
|---|---|
| DOI | https://doi.org/10.1186/ISRCTN15269213 |
| IRAS number | 265964 |
| Secondary identifying numbers | CPMS 58492, IRAS 265964, WKR0 - 2019 - 0036 |
- Submission date
- 03/06/2024
- Registration date
- 24/03/2025
- Last edited
- 24/03/2025
- Recruitment status
- Recruiting
- Overall study status
- Ongoing
- Condition category
- Pregnancy and Childbirth
Plain English Summary
Background and study aims
We do not have very good information about how well neuraxial anaesthesia (anaesthesia that aims to numb part of your body whilst remaining awake) during caesarean section performs, nor how intraoperative pain should be managed, or what the outcomes are for patients who experience pain during awake caesarean sections.
The aims of this study are to:
1. Estimate how often awake caesarean section surgery fails and intraoperative pain is experienced
2. Use patient-centred tools to assess the impact on patients who experience pain during awake caesarean section
Who can participate?
Every adult patient aged 18 years and over who has a caesarean section, including if the caesarean section is planned or unplanned (an urgent or emergency case), at any time of day or night, and is done awake using NA.
What does the study involve?
There will be three points of data collection.
Form 1 will be completed by the responsible anaesthetist for the case. It will collect basic anaesthetic, obstetric, and surgical information. There will be nothing on Form 1 that is not already routinely collected by hospitals for all caesarean sections.
Form 2 will be filled in by the researcher together with the patient between 18 and 30 hours after the caesarean. It will consist of questions regarding their experience of the caesarean section, any intraoperative pain or discomfort they may have experienced, their satisfaction with the anaesthetic care, and the quality of the recovery. It is estimated that this will take about 10-15 minutes.
Form 3 will be filled in by a researcher who calls the patient about 6 weeks after the caesarean section. The form will consist of questionnaires to help identify the impact to those who have had any negative experiences, compared to those who did not. These are validated questionnaires that are used to identify post-traumatic stress and post-natal depression. This will probably take about 10-15 minutes.
Should a patient score above a specific threshold on these Form 3 questionnaires, they will receive a letter informing them, with a list of resources. Their GP will also be informed by letter.
What are the possible benefits and risks of participating?
There will be no specific benefit for the participants by taking part. For the future, the results of this study will help us to better understand and manage pain during caesarean section, but also have better information when consenting patients for caesarean section and discussing risks.
The researchers do not think there are any disadvantages or risks to taking part. There is a small possibility that answering the questionnaire may cause you to worry or feel anxious about your anaesthetic or your recovery. Some of the questions asked at the 6-week telephone call will be about your current mood. In this call, the researchers will be using questionnaires aiming to screen for anxiety, depression, and post-traumatic stress, If the questionnaire scores suggest that you might have such symptoms, then the researchers will let you know at the time, and encourage you to visit your GP if you think that’s right. The researchers will also write to you and your GP, letting them know. The letter for you will include resources and groups available to you, that you may find beneficial.
Where is the study run from?
University College London Hospital (UK)
When is the study starting and how long is it expected to run for?
April 2019 to August 2025
Who is funding the study?
1. National Institute of Academic Anaesthesia (NIAA) (UK)
2. NIHR Central London Patient Safety Research Collaboration (UK)
Who is the main contact?
Prof. Ramani Moonesinghe, Ramani.moonesinghe@nhs.net
Contact information
Principal Investigator
University College London Hospital
235 Euston Road
London
NW1 2BU
United Kingdom
 ORCID ID |
0000-0002-6730-5824 |
|---|---|
| Ramani.moonesinghe@nhs.net |
Scientific
University College London Hospital
235 Euston Road
London
NW1 2BU
United Kingdom
| ORCID ID |
0000-0002-5577-886X |
|---|---|
| Reshma.patel21@nhs.net |
Scientific
University College London Hospital
235 Euston Road
London
NW1 2BU
United Kingdom
| ORCID ID |
0000-0001-7070-2276 |
|---|---|
| James.ocarroll@nhs.net |
Study information
| Study design | Non-randomized; Both; Design type: Screening, Diagnosis, Education or Self-Management, Management of Care, Cohort study |
|---|---|
| Primary study design | Interventional |
| Secondary study design | Non randomised study |
| Study setting(s) | Hospital |
| Study type | Treatment |
| Participant information sheet | 45562_PIS.pdf |
| Scientific title | Snapshot obstetric national anaesthetic research project 1 (SONAR-1) |
| Study acronym | SONAR 1 |
| Study hypothesis | Study hypothesis: Intraoperative pain during awake caesarean section has a negative impact on short- and medium-term postoperative outcomes. Research Questions: RQ1: What is the incidence of intraoperative pain reported by patients during caesarean birth performed with neuraxial anaesthesia? RQ2 What is the incidence of incidence of intraoperative pain reported by clinicians during caesarean birth performed with neuraxial anaesthesia? RQ3: What are the hospital, patient, clinician, anaesthetic, and obstetric-related factors associated with the incidence of pain during caesarean birth performed under neuraxial anaesthesia? RQ4: What are the hospital, clinician, patient, anaesthetic, and obstetric-related factors associated with the short- and longer-term outcomes following caesarean birth performed under neuraxial anaesthesia? Objectives: 1. To estimate the incidence of patient and clinician-reported intraoperative pain during caesarean birth conducted with neuraxial anaesthesia 2. To describe how intraoperative pain is managed4, and to describe how successful practice strategies are 3. To evaluate day-1 and 6-week patient-reported outcomes related to intraoperative pain during Caesarean birth 4. To evaluate the physical and psychological impact on patients of caesarean birth in the short- and medium-term using patient-reported outcome measures |
| Ethics approval(s) | Approved 24/05/2024, Leicester Central Research Ethics Committee (2 Redman Place, Stratford, Health Research Authority, E20 1JQ, UK; +44 (0)207 104 8066, +44 (0)207 104 8227, +44 (0)207 104 8284; leicestercentral.rec@hra.nhs.uk), ref: 24/EM/0084 |
| Condition | Reproductive health and childbirth |
| Intervention | SONAR-1 is a study of obstetric patients undergoing caesarean sections (CS) in participating hospitals to understand how common intraoperative pain and inadequate neuraxial anaesthesia (NA)(where the patient is made numb, but is not asleep) is. Data will be collected on all patients meeting the inclusion criteria in our participating UK hospital, UCLH, during the 4-week study period (where the aim is to recruit at least 100 patients). If the pilot study is felt to be feasible, the researchers plan to roll the study out to more hospitals, to get a feel of the scale of this problem in the whole country. Abbreviation: Throughout this summary the abbreviation NA is used. This stands for Neuraxial Anaesthesia. This is a collective term used to mean either: 1. An injection into the bottom of the back, which leaves the recipient awake and pain-free during surgery. This is known as a spinal. 2. An injection in the bottom of the back, which is done to place a catheter through which pain medication can be given. This is known as an epidural. If an anaesthetist gives specific additional medication through the epidural, then the epidural can be used to keep a patient comfortable during a caesarean section (CS). NA is the ideal mode of anaesthesia used for caesarean sections but it is not always possible for medical reasons. In these cases, a general anaesthetic (GA) is used. This is sometimes referred to as ‘going off to sleep’. Introduction: We do not have very good information about how well neuraxial anaesthesia during caesarean section performs, nor how intraoperative pain should be managed, or what the outcomes are for patients who experience pain during awake caesarean sections. The aim of SONAR-1 is to: 1. Estimate how often NA fails and intraoperative pain is experienced during caesarean section 2. To use patient-centred tools to assess the impact on patients who experience pain during a caesarean section Who will we involve? Every adult patient who has a caesarean section, including if the caesarean section is planned or unplanned (an urgent or emergency case), at any time of day or night, and is done awake using NA. Data collection: There will be three points of data collection. Form 1 will be completed by the responsible anaesthetist for the case. It will collect basic anaesthetic, obstetric, and surgical information. There will be nothing on Form 1 that is not already routinely collected by hospitals for all caesarean sections. Form 2 will be filled in by the researcher together with the patient between 18 and 30 hours after the caesarean. It will consist of questions regarding their experience of the caesarean section, any intraoperative pain or discomfort they may have experienced, their satisfaction with the anaesthetic care, and their quality of the recovery. It is estimated that this will take about 10-15 minutes. Form 3 will be filled in by a researcher who calls the patient approx. 6 weeks after the caesarean section. The form will consist of questionnaires to help identify the impact to those who have had any negative experiences, compared to those who did not. These are validated questionnaires that are used to identify post-traumatic stress, anxiety, and post-natal depression. This will probably take about 10-15 minutes. Should a patient score above a specific threshold on these Form 3 questionnaires, they will receive a letter informing them, with a list of resources. Their GP will also be informed by letter. The results of this study will help us to better understand and manage pain during caesarean section, but also have better information when consenting patients for caesarean section and discussing risks. Study schedule: The patient is given a Patient Information Sheet about the surgery as early as possible within reason. This might be in a clinic, or a delivery suite, or a consultant-led labour ward. If there are any study-specific questions, these will be answered by a researcher on site. In urgent or emergency cases, this may occur after the baby is born. Patients are approached to be consented into the study at the earliest opportunity after the caesarean section within reason. This will likely be in the recovery area. If the patient has been given the Patient Information Sheet after the baby is born, then they will be given at least one hour to consider the information before being approached for consent. Form 1 will have already been completed by the anaesthetist, and as it is solely obstetric, anaesthetic and surgical data that is routinely collected, consent is not required. All patients who consent will be entered into the study log so that they can be followed up at 24 hours and 6 weeks. Patients who do not consent are also entered into the study log kept on site, but only so that researchers know how many people do not wish to consent. They will not then be contacted by the researchers. Only researchers who have undergone confidentiality and research method training will have access to the study log. Patients who do consent will complete Form 2 with a researcher no later than 24 hours (+/- 6 hours) after the caesarean section. Patients will then be contacted by telephone using a number they provide whilst completing Form 2 at 6 weeks (+/- 3 days) following the caesarean section. Three attempts will be made to contact the patients, but appropriate judgement will be used as it is not always possible to find time to speak on the phone in the newborn period. It is anticipated that Form 3 will take 15 minutes to complete. Researchers will be led by the patients as to when might be a good time for us to call. All the information from all the forms is entered into a study database, and there is no identifiable patient information on that database. It is specifically encrypted so that no one can be identified by looking at the database. Withdrawal: Participants are free to withdraw from the study at any time and without reason. This will be recorded in the study log only to prevent unnecessary follow-up. If they withdraw before recruitment is complete, their data will be removed from the study log and not used for analysis. If withdrawal is after the study closes, it will not be possible to remove their data as analysis will have started. This will be made clear on the study Information Sheet. |
| Intervention type | Procedure/Surgery |
| Primary outcome measure | The incidence of patient-reported intraoperative pain during caesarean delivery performed with neuraxial anaesthesia |
| Secondary outcome measures | 1. Pain measured using the visual analog scale at 24 hours (+/- 6 hours) after delivery of the baby 2. Maternal satisfaction measured using the Maternal Satisfaction questionnaire tool at 24 hours (+/- 6 hours) after delivery of the baby 3. Pain measured using the visual analog scale at 6 weeks (+/- 3 days) after delivery of the baby 4. Anxiety measured using the Generalised Anxiety Disorder Scale (GAD7) at 6 weeks (+/- 3 days) after delivery of the baby 5. Post-traumatic stress measured using the Post-Traumatic Stress Checklist (PCL-5) at 6 weeks (+/- 3 days) after delivery of the baby 6. Depression measured using the Edinburgh Postnatal Depression Score (EPDS) at 6 weeks (+/- 3 days) after delivery of the baby |
| Overall study start date | 10/04/2019 |
| Overall study end date | 01/08/2025 |
Eligibility
| Participant type(s) | Patient |
|---|---|
| Age group | Adult |
| Lower age limit | 18 Years |
| Sex | Female |
| Target number of participants | Planned Sample Size: 1500; UK Sample Size: 1500 |
| Participant inclusion criteria | 1. Aged 18 years or above 2. Gestation beyond 32/40 weeks 3. Receiving NA (spinal, labour epidural extended for surgical anaesthesia or combined spinal epidural) 4. Receiving any scheduled or unscheduled CS of any category |
| Participant exclusion criteria | 1. Patient refusal 2. Patients who are unable to provide informed consent 3. Other modes of delivery (e.g., instrumental delivery) 4. De novo GA as an anaesthetic method |
| Recruitment start date | 17/03/2025 |
| Recruitment end date | 17/05/2025 |
Locations
Countries of recruitment
- Australia
- England
- Northern Ireland
- Scotland
- United Kingdom
- Wales
Study participating centres
London
NW1 2PQ
United Kingdom
United Kingdom
Sponsor information
University/education
UCLH/UCL Joint Research Office UCL (part of the Research Support Centre)
1st Floor Maple House (Suite B)
124 Tottenham Court Road
London
W1T 7DN
England
United Kingdom
| Phone | +44 (0)203 447 5696 |
|---|---|
| uclh.randd@nhs.net | |
| Website | http://www.ucl.ac.uk/ |
"ROR" |
https://ror.org/02jx3x895 |
Funders
Funder type
Government
Government organisation / Local government
- Alternative name(s)
- NIAA
- Location
- United Kingdom
Government organisation / Local government
- Alternative name(s)
- NIAA
- Location
- United Kingdom
Results and Publications
| Intention to publish date | 01/10/2026 |
|---|---|
| Individual participant data (IPD) Intention to share | No |
| IPD sharing plan summary | Data sharing statement to be made available at a later date |
| Publication and dissemination plan | Planned publication in a high-impact peer-reviewed journal |
| IPD sharing plan | The data-sharing plans for the current study are unknown and will be made available at a later date |
Study outputs
| Output type | Details | Date created | Date added | Peer reviewed? | Patient-facing? |
|---|---|---|---|---|---|
| Participant information sheet | version 1.2 | 21/05/2024 | 29/07/2024 | No | Yes |
| Protocol file | 29/07/2024 | No | No |
Additional files
Editorial Notes
03/06/2024: Study's existence confirmed by the NIHR.
