Ongoing, recruitingTherapeutic exploratory (Phase II)Interventional

Randomized, multi-center, double-blind, two-armed, parallel active groups, prospective trial, to evaluate, in pediatric population undergoing 'Calcaneo stop' surgery or Inguinal hernia repair, the efficacy and safety of chloroprocaine 1% and 2% for peripheral nerve block based on concentration-response relationships.

This study is testing two different strengths of a numbing medicine called chloroprocaine. Doctors use similar medicines to block pain during operations. The study focuses on children having either a `Calcaneo stop` surgery (which corrects a problem with the foot) or an inguinal hernia repair (which fixes a common type of bulge in the tummy area). The main goal is to find out which strength of chloroprocaine works best to prevent pain so that children don't need other pain medicines during surgery. Researchers will also look at how quickly the numbing effect starts, how long it lasts, and how well children manage their pain after the operation. This will help doctors choose the best and safest pain relief for children in the future.

At a glance

Status

Ongoing, recruiting

Phase

Therapeutic exploratory (Phase II)

Sponsor

Sintetica S.A.

Enrolment target

174

Start

05 Nov 2024

Calcagno stop and inguinal hernia repair

What is this study about?

Imagine your child needs surgery, and you want them to feel as little pain as possible. This study is exploring a way to do just that for children having two common operations: `Calcaneo stop` surgery, which helps correct certain foot problems, and inguinal hernia repair, a common surgery for a bulge in the groin area. We are looking at a medicine called chloroprocaine, which is a type of local anaesthetic. This medicine is used to numb a specific part of the body, helping to stop pain signals from reaching the brain during and after surgery.

In this study, two different strengths of chloroprocaine will be tested. The main aim is to see which strength works best at stopping pain effectively during surgery so that children don't need extra pain relief for the surgical area. Researchers will also be checking how quickly the numbing effect starts, how long it lasts, and how well children are able to move their legs and feet after the surgery. Pain levels will also be carefully monitored after the operation using age-appropriate tools.

The findings from this study are really important because they will help doctors understand the best and safest way to use chloroprocaine for pain relief in children undergoing these specific surgeries. This could lead to better pain management for many children in the future, helping them to recover more comfortably after their operations.

Key takeaways

The study tests two strengths of a numbing medicine (chloroprocaine) for children's surgeries.
It focuses on `Calcaneo stop` surgery and inguinal hernia repair.
The main goal is to find the best dose to prevent pain during surgery.
Researchers will also check how quickly the medicine works and for how long.
Pain will be carefully managed and measured after the operation.
Results will help doctors choose better pain relief for children in the future.

Who may be eligible?

This study is open to children of any age who are scheduled to have either `Calcaneo stop` surgery or an inguinal hernia repair. Both boys and girls can take part.

Before your child can join, the study team will need to check some other things about their health to make sure the study is a good fit for them. This is to ensure their safety and the accuracy of the study results.

It's important to remember that even if your child fits the general age and surgery type, there might be other medical reasons why they can't join. The study team will discuss all the details with you.

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.

Is my child scheduled for `Calcaneo stop` surgery?
Is my child scheduled for an inguinal hernia repair?
Is my child of any age?
Is my child male or female?

Answer every question to see your result.

What does participation involve?

If your child takes part in this study, they will receive one of the two different strengths of chloroprocaine to numb the area for their surgery. Other common medications such as midazolam (to help with calm), fentanyl and tramadol (pain relief), paracetamol (pain relief), and sevoflurane (an anaesthetic gas) may also be used as needed.

During and after the surgery, the study team will carefully monitor your child. They'll check when the numbing medicine starts to work, whether additional pain medicine is needed during the operation, and how quickly your child recovers movement and how they manage pain afterwards. They'll use different pain scales depending on your child's age. There will be checks immediately after waking up and at set times (30 minutes, 1 hour, 2 hours, 3 hours) up until your child is ready to go home. The total duration of participation will focus on your child's time in the hospital, from before surgery until they are ready for discharge.

Potential risks and benefits

Participating in this study might offer your child the potential benefit of receiving an effective and well-monitored pain relief plan during their surgery. The information gathered will also help improve pain relief for other children in the future. As with any medical procedure or medication, there are always potential risks, such as side effects from the medications used, which the study doctors will explain fully. You are free to withdraw your child from the study at any time, for any reason, without it affecting their medical care.

Locations (1)

Some site locations are approximate. We're improving this — please verify with the trial team before travelling.

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Unverified
Italy

Common questions

What exactly is 'Calcanao stop' surgery?

`Calcaneo stop` surgery is an operation typically done to correct certain foot conditions, particularly those involving the heel bone.

What is an inguinal hernia repair?

An inguinal hernia repair is a common surgery to fix a bulge in the lower tummy or groin area that often contains fatty tissue or part of the intestine.

Will my child know if they're getting the 1% or 2% strength of the medicine?

No, this is a 'double-blind' study, meaning neither you, your child, nor the doctors caring for them will know which strength of chloroprocaine is being given. This helps ensure fair and unbiased results.

What if my child feels pain during the surgery?

The medical team will be closely monitoring your child. If they show any signs of pain during surgery, they will be given additional pain relief straight away, just as they would in any other surgery.

What kind of pain assessment will be used for my child?

The type of pain assessment will depend on your child's age. For very young children, doctors might use observation scales. For older children, they might use picture-based scales or ask them directly about their pain.