Study on the Effectiveness and Safety of Chloroprocaine Hydrochloride for Children Undergoing Flat Foot or Inguinal Hernia Surgery

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What is this study about?

This clinical trial is focused on evaluating the effectiveness and safety of a local anesthetic called chloroprocaine hydrochloride in children undergoing surgery for flat foot or inguinal hernia. The study involves using two different concentrations of chloroprocaine, 1% and 2%, to determine how well it works in blocking nerve pain during these procedures. The anesthetic is administered through an injection near the nerves, guided by ultrasound, to ensure precise delivery.

In addition to chloroprocaine, other medications such as midazolam, fentanyl citrate, tramadol hydrochloride, paracetamol (also known as acetaminophen), and sevoflurane may be used during the study. These medications serve various roles, such as providing sedation, pain relief, or additional anesthesia if needed. The trial aims to assess how many patients do not require additional anesthesia during surgery, as well as other factors like the time it takes for the anesthetic to start working and how long it lasts.

The study is designed to gather information on the overall recovery of patients, including their pain levels and any side effects they might experience. The goal is to ensure that the anesthetic is both effective and safe for use in children undergoing these specific surgeries. Participants will be monitored closely throughout the process to ensure their well-being and to collect valuable data on the anesthetic’s performance.

1 joining the study

Upon joining the study, the patient is assessed to ensure they meet the eligibility criteria. This includes being a pediatric patient scheduled for either ‘calcaneo stop’ surgery or inguinal hernia repair.

The patient must be in good health, with a normal body mass index or development, and classified as ASA I or ASA II, which indicates a low risk during anesthesia.

2 preparation for surgery

Before surgery, the patient receives an injection of chloroprocaine at either 1% or 2% concentration. This is administered perineurally, meaning around the nerves, to block pain during the procedure.

The injection is guided by ultrasound to ensure accuracy and effectiveness.

3 during surgery

The primary goal is to avoid the need for additional anesthesia during surgery. The effectiveness of the chloroprocaine is monitored to ensure the patient does not require rescue anesthesia.

If necessary, fentanyl may be administered as a rescue anesthesia.

4 post-surgery monitoring

After surgery, the time it takes for the sensory block to wear off is measured. This involves checking when the patient regains sensation using a pinprick test and heart rate monitoring.

The patient’s ability to move their legs and feet is assessed using the Bromage scale, which measures motor block regression.

5 pain assessment

Pain levels are evaluated multiple times within the first three hours after the patient wakes up. Different scales are used based on the patient’s age, such as the COMFORT scale for very young patients and the Wong-Baker scale for older children.

The need for additional pain relief, such as tramadol or paracetamol, is determined based on these assessments.

6 discharge eligibility

The time from the end of surgery to when the patient meets the criteria for discharge is recorded. This is based on the Pediatric Post Anesthesia Discharge Scoring System (Ped-PADSS).

The actual discharge may occur later, depending on hospital procedures.

7 follow-up evaluations

The patient’s recovery is evaluated through questionnaires completed by the investigator on the day of the surgery, the day after, and seven days post-surgery.

These evaluations check for any prolonged loss of sensation or motor activity, as well as any adverse events such as pain at the injection site or neurological symptoms.

Who Can Join the Study?

Children and teenagers, both boys and girls, aged from 28 days after birth to less than 18 years old.
Scheduled for specific surgeries:
- Calcaneo stop surgery for children and teenagers aged 6 to less than 18 years, which involves a type of foot surgery.
- Inguinal hernia repair for infants and young children aged 28 days to 6 years, which involves fixing a hernia in the groin area.
Must be normally active and considered healthy based on medical history and physical examination.
Must have a normal body weight and height according to local pediatric charts.
Must be classified as ASA I or ASA II, which means they are healthy or have mild systemic disease.
Parents or guardians must provide written informed consent, understanding the study’s purpose, risks, and requirements.
Children and teenagers must also provide their own written informed consent, in addition to their parents or guardians.
Children and teenagers must be willing and able to follow the study requirements.

Who Cannot Join the Study?

Patients with allergies to the medication being tested cannot participate.
Patients with a history of severe reactions to anesthesia are excluded.
Patients with certain heart conditions are not eligible.
Patients with liver or kidney problems cannot join the study.
Patients who are pregnant or breastfeeding are not allowed to participate.
Patients currently taking medications that might interfere with the study drug are excluded.
Patients with a history of drug or alcohol abuse are not eligible.
Patients with any other medical condition that might make participation unsafe are excluded.

Where you can join this trial?

Verified and Recommended Sites

No sites found in this category

Verified Sites

Site Name	City	Country	Status
Fondazione Policlinico Universitario Agostino Gemelli IRCCS	Rome	Italy

Other Sites

Site Name	City	Country
Ospedale San Raffaele S.r.l.	Milan	Italy
Ospedale Pediatrico Bambino Gesu’	Rome	Italy
Acjquch Ofcttjuxvsl Ufkemvqcybfpp Cmgalgogrlxf Deaof Skqkvm E Dyxca Shjudhb Dq Ttvqjq	Turin	Italy

Trial status

Country	Status	Recruitment Start
Italy	Not recruiting	01.03.2019

Trial locations

Investigated drugs:

Chloroprocaine: This medication is used in the trial to provide anesthesia for children undergoing certain surgeries, such as ‘Calcaneo stop’ surgery or inguinal hernia repair. It is administered through an injection near the nerves, guided by ultrasound, to block pain in a specific area of the body. The study is evaluating how effective and safe chloroprocaine is when used in different concentrations to prevent the need for additional anesthesia during surgery.

Investigated diseases:

Inguinal hernia

Inguinal Hernia – An inguinal hernia occurs when tissue, such as part of the intestine, protrudes through a weak spot in the abdominal muscles. This condition is more common in men and can cause a noticeable bulge in the groin area, which may become more apparent when standing up or coughing. The hernia may cause discomfort or pain, especially when bending over, lifting, or coughing. Over time, the hernia can increase in size and may lead to complications if not addressed.

Calcaneal Apophysitis (Sever’s Disease) – Calcaneal apophysitis, commonly known as Sever’s disease, is a condition that affects the heel’s growth plate in children and adolescents. It is often caused by repetitive stress or overuse, particularly in active children who participate in sports. The condition leads to heel pain, especially during physical activities, and may cause limping or difficulty walking. The pain typically worsens with activity and improves with rest.

Trial ID:

2024-518179-76-00

Protocol code:

CHL.2/04-2015

Trial Phase:

Therapeutic exploratory (Phase II)

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Study on the Effectiveness and Safety of Chloroprocaine Hydrochloride for Children Undergoing Flat Foot or Inguinal Hernia Surgery

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