Evaluation of Chloroprocaine Hydrochloride 1% and 2% for Peripheral Nerve Block in Pediatric Patients Undergoing Calcaneo Stop or Inguinal Hernia Repair

The primary objective of this study is to evaluate the **efficacy** of chloroprocaine at concentrations of 1% and 2%, administered via perineural, ultrasound-guided injection, in a pediatric population undergoing 'Calcaneo stop' surgery or inguinal hernia repair. The assessment focuses on the proportion of subjects who do not require rescue anesthesia during surgery, which is clinically relevant as it indicates the effectiveness of the anesthetic in achieving a successful peripheral nerve block.

Secondary objectives include evaluating the time required for the onset of sensory block and the regression of motor block, using a standard Bromage scale, in the context of calcaneal procedures. Additionally, the study will assess pain intensity, the time needed to meet discharge eligibility criteria, and the necessity, timing, and dosage of rescue anesthesia (fentanyl) during surgery. Safety assessments will focus on the general tolerability and safety of the study drug, including adverse events, pain at the injection site, and neurological and cardiac symptoms observed during surgery following the injection of the investigational medicinal product (IMP).

The clinical trial involves a **pediatric population** with a focus on assessing the efficacy of chloroprocaine for peripheral nerve block during surgery. The study includes both male and female participants, ranging from 28 days old to under 18 years of age. Participants are scheduled for either 'calcaneo stop' surgery, targeting children and adolescents aged 6 to under 18 years, or inguinal hernia repair, involving newborns, infants, toddlers, and children aged 28 days to 6 years. All participants are required to be normally active and in good health, as determined by medical history and physical examination, with a normal lean body mass or normal body development according to local pediatric height and weight charts. The trial includes patients classified as ASA I and ASA II. The sponsor has not provided the total number of participants. The selection criteria emphasize the importance of obtaining written informed consent from parents or tutors, with additional consent from children and adolescents when applicable. The trial does not involve a vulnerable population, and no specific lifestyle considerations such as diet or physical activity are highlighted.

The clinical trial is designed as a **randomized**, multi-center, double-blind, two-armed, parallel active groups, prospective study. It aims to evaluate the efficacy and safety of **chloroprocaine hydrochloride** at concentrations of 1% and 2% for peripheral nerve block in a pediatric population undergoing 'Calcaneo stop' surgery or inguinal hernia repair. The trial is expected to run from March 1, 2019, to March 31, 2025, with the primary objective being the assessment of the efficacy of chloroprocaine in terms of the proportion of subjects not requiring rescue anesthesia during surgery.

Participants will be involved in the study for a maximum treatment period of one day. The study includes several key visits: an initial screening visit to determine eligibility based on inclusion criteria such as age, health status, and consent, followed by the administration of the investigational medicinal product (IMP) on the day of surgery. Follow-up visits will occur immediately after surgery and at specified intervals to assess recovery and any adverse events. The end-of-study visit will evaluate the overall recovery and any long-term effects.

Inclusion criteria require participants to be pediatric patients aged 28 days to less than 18 years, scheduled for specific surgeries, and in good health. Exclusion criteria are not specified in the provided data. Participants may be terminated early from the study if they experience significant adverse events or if they withdraw consent. The primary endpoint is the proportion of patients not requiring rescue anesthesia, with secondary endpoints including time to sensory block onset, pain intensity, and time to eligibility for home discharge.

The clinical trial involves the administration of **chloroprocaine hydrochloride** as the primary experimental medication. Chloroprocaine hydrochloride is provided in a solution for injection form, with a concentration of either 1% or 2%. The medication is administered via **perineural use**, specifically through ultrasound-guided injection, to achieve a peripheral nerve block. The maximum daily dose is 10 mg/ml or 20 mg/ml, depending on the concentration used, with a treatment period limited to one day. The primary objective is to evaluate the efficacy of chloroprocaine hydrochloride in preventing the need for rescue anesthesia during surgery in a pediatric population.

**Tramadol hydrochloride** and **paracetamol** are used as auxiliary medications in the trial. This combination is administered orally, with a maximum daily dose of 400 mg. The pharmaceutical form is denoted as PHF00082MIG. These substances serve as analgesic and antipyretic agents, supporting the primary treatment by managing pain and fever.

Another auxiliary treatment includes a combination of **buclizine hydrochloride**, **paracetamol**, and **codeine phosphate**, administered via intravenous injection. The maximum daily dose for this combination is 4 mg, and it is also provided in the pharmaceutical form PHF00082MIG. This combination is used for its analgesic properties.

**Fentanyl citrate** is administered as an auxiliary medication through intravenous injection. The maximum daily dose is 50 µg/Kg, and it is provided in the pharmaceutical form PHF00231MIG. Fentanyl citrate is utilized for its potent analgesic effects.

**Sevoflurane** is used as an auxiliary anesthetic agent, administered via inhalation. The maximum daily dose is 8%, and it is provided in the pharmaceutical form PHF00115MIG. Sevoflurane is employed for its anesthetic properties during surgical procedures.

**Dobutamine hydrochloride** is administered as an auxiliary treatment via injection, with a maximum daily dose of 0.5 mg/Kg. It is provided in the pharmaceutical form PHF00230MIG and is used for its sedative-hypnotic effects.

Participant compliance with the dosing schedule is monitored throughout the trial to ensure adherence to the prescribed treatment regimen. The trial is designed to assess the efficacy and safety of the experimental and auxiliary treatments in achieving the desired clinical outcomes.

The efficacy of **chloroprocaine** in pediatric patients undergoing 'Calcaneo stop' surgery or inguinal hernia repair will be assessed through a randomized, multi-center, double-blind, two-armed, parallel active groups, prospective trial. The primary efficacy endpoint is the overall proportion of patients in each dosage group not requiring rescue anesthesia during surgery. Secondary endpoints include the proportion of patients not requiring rescue anesthesia during each surgical procedure, time to onset of sensory block, time to regression of motor block, pain intensity, time to eligibility for home discharge, and the need for additional analgesia post-surgery.

Measurements will be conducted using various validated tools and scales appropriate for the patient's age. Pain intensity will be evaluated using the COMFORT scale for patients under 2 months, the FLACC scale for those aged 2 months to 6 years, and the Wong-Baker scale for patients over 6 years. The time to onset of sensory block will be assessed by a pinprick test associated with heart rate measurement. The time to regression of motor block will be evaluated using the standard Bromage scale. These assessments will be conducted at specified intervals post-surgery, including immediately after awakening and at 30 minutes, 1 hour, 2 hours, and 3 hours after the first evaluation.