CompletedInterventional

How common is intraoperative pain occur during caesarean delivery surgery when the patient is awake and what is the impact on mothers?

This study, called SONAR-1, is exploring how often mothers feel pain during a C-section when they are awake and how this experience affects them. Currently, we don't know enough about how well pain relief works during these surgeries or what the lasting impact is for mothers who feel pain. Researchers want to understand the experiences of mums undergoing C-sections to improve care in the future. They will collect information from adult women having C-sections, whether planned or unplanned, focusing on their comfort during surgery and how they feel afterwards, including their recovery and wellbeing.

At a glance

Status

Completed

Sponsor

University College London

Enrolment target

1,500

Start

17 Mar 2025

Estimated completion

17 May 2025

Reproductive health and childbirth

What is this study about?

Imagine you're having a C-section, and you're awake for it. This study, called SONAR-1, wants to understand how often mums might feel some pain *during* an awake C-section and what that experience means for them afterwards. Researchers realise we don't have enough clear information about how well the pain relief (called neuraxial anaesthesia) truly works in every case, or how best to help mums who do feel pain. They also want to understand the long-term effects of such experiences.

The main goals are to find out two things: firstly, how many times mums experience pain during an awake C-section, and secondly, how that pain affects them later on. They'll be using special questionnaires to get a clear picture from the mums themselves, focusing on their comfort and feelings.

Ultimately, the hope is that by gathering this information, hospitals and doctors can better understand pain during C-sections. This will help them improve how pain is managed and give better advice and support to mums before their C-section, making the experience as comfortable and positive as possible.

Key takeaways

This study wants to learn about pain during awake C-sections and its impact.
It aims to improve future care and information for mums having C-sections.
Participation involves answering questions about your experience after birth and at 6 weeks.
There are no direct benefits to you, but it helps future mothers.
You stay anonymous, and your medical care isn't affected by joining or leaving the study.

Who may be eligible?

This study is looking for women who are 18 years old or older and are having a C-section. This includes both C-sections that have been planned ahead of time and those that happen unexpectedly or in an emergency.

To be part of the study, you must be having your C-section while you are awake, using a type of pain relief that numbs part of your body (like a spinal or epidural). You won't be able to join if you are having a general anaesthetic (where you are fully asleep). You also need to be able to understand the study information and agree to take part.

Could this study suit you?

Answer these quick questions to see if you may be eligible. This is a guide only — the research team makes the final call.

Are you 18 years old or older?
Are you having a C-section (planned or unplanned)?
Will you be awake during your C-section with pain relief like a spinal or epidural?
Are you able to understand and agree to take part in the study?

Answer every question to see your result.

What does participation involve?

If you decide to take part in this study, there will be three main steps to collect information. First, the anaesthetist helping you during your C-section will fill out a form with basic details about your anaesthetic, birth, and surgery. This is all routine information that hospitals usually collect anyway.

About 18 to 30 hours after your C-section, a researcher will spend about 10-15 minutes with you. They will ask you about your experience during the C-section, if you felt any pain or discomfort, how satisfied you were with your pain relief, and how you are recovering.

Finally, about six weeks after your C-section, a researcher will call you. This call will also take about 10-15 minutes. During this call, they will ask you some questions using standard questionnaires. These questions are designed to check your mood and identify if you're experiencing symptoms of anxiety, depression, or post-traumatic stress. If your answers suggest you might be struggling, the researchers will let you know, and encourage you to speak to your GP. They will also send you and your GP a letter with information and resources that might help you.

Potential risks and benefits

Taking part in this study won't directly benefit you as an individual. However, the information gathered will help doctors and nurses better understand and manage pain during C-sections in the future. This means they can improve care for other mums, give better advice, and explain potential risks more clearly before surgery. The researchers believe there are no disadvantages or risks to taking part. It's possible that answering some questions about your experience or mood might make you feel a little anxious or worried temporarily. If the questions at six weeks suggest you might be experiencing anxiety, depression, or post-traumatic stress, the researchers will tell you, encourage you to see your GP, and provide resources. Remember, you can always change your mind and stop participating in the study at any time without it affecting your medical care.

Locations (2)

Uclh
Approximate
London, United Kingdom
Eligible NHS Hospitals
Unverified
United Kingdom

Common questions

What is 'neuraxial anaesthesia'?

It's a type of pain relief used during C-sections that numbs a part of your body, but you stay awake. Examples include spinal blocks or epidurals.

Will I get special treatment if I join?

No, you'll receive the same excellent care as any other patient. The study is about observing experiences, not changing treatment.

What if I feel distressed by the questions?

The researchers are aware this might happen. If your answers suggest you need support, they will tell you and provide information on who to contact, like your GP.

Who will see my answers?

Your personal information will be kept private and anonymized where possible. Only the research team will access the detailed study data.

How long will the study run for?

The study started in April 2019 and is expected to collect data until August 2025.

How to find out more

Ramani Moonesinghe

Ramani.moonesinghe@nhs.net - Official trial record

Always speak to your GP or specialist before deciding to take part in a study.