Hemodynamic Impact of Epidural Anesthesia in Relation to Age in Pediatric Patients. (REHAEPP-2022)

Epidural analgesia is established as the gold standard in the management of post-surgical pain in multiple modalities, including the pediatric patient. It is a technique that is not without risks, but with multiple benefits such as less response to stress, less incidence of chronic pain after surgery, less incidence of nausea and vomiting and other adverse effects derived from opioids, faster recovery and increased patient and family satisfaction.

However, as it has been mentioned, the epidural carries risks both in the technique itself (wet or intravascular puncture) and subsequently after the injection of medication that generates a sympathetic blockade with arterial hypotension and an increase in compensatory heart rate. Unlike in adult patients, in pediatric patients epidural and subarachnoid anesthesia are better tolerated hemodynamically due to less vagal and sympathetic activity and almost no systemic venodilation. This lower activity of the autonomic nervous system is due to its immaturity, which is why, with the growth of the infant, this anesthetic technique increasingly affects its hemodynamics, being similar to the adult at the age of 8-12 years.

The study hypothesis does not differ from that stated in physiology books and studies, but the investigators seek to identify the direct correlation of age with the different hemodynamic parameters available with current technology (cardiac output, systemic vascular resistance, blood pressure ) in pediatric patients after epidural anesthesia.

The study will be carried out in pediatric patients undergoing major surgery that requires the placement of an epidural catheter and invasive blood pressure, without modifying in any way the usual practice of the responsible anesthesiologist. The patient's hemodynamic data will be collected at time 0 (prior to catheter placement), one minute, 5 and 10 minutes after the bolus of local anesthetic administered to measure the child's hemodynamic response and relate it to their age and development. .

Study Overview

• Status: Recruiting
• Conditions: Epidural Analgesia; Hemodynamic Monitoring; Anesthesia; Adverse Effect; Pediatric Major Surgery
• Intervention / Treatment: Drug: Levobupivacaine

Detailed Description

Through this work the investigators seek to establish statistically and numerically a hypothesis affirmed in physiology books. In this way, if it is found a positive correlation with age and hypotension, the responsible physician can be alerted to the need for possible vasoconstrictor requirements or more advanced monitoring in order to reduce intraoperative risks.

• Study Type: Observational
• Enrollment (Anticipated): 15

Contacts and Locations

Study Locations

• Spain
  • Valencia, Spain, 46026
    • Recruiting
    • Daniel Perez Ajami
    • Contact: Daniel Perez, M.D; Phone Number: +34625917333; Email: daniajami1995@gmail.com
    • Principal Investigator: Daniel Pérez Ajami, M.D

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 1 second to 12 years (Child)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: All

• Sampling Method: Non-Probability Sample

Study Population

Patients under 12 years of age undergoing major surgery in the University Hospital La Fe, in Valencia

Description

Inclusion Criteria:

• Patients under 12 years of age undergoing major surgery with epidural catheter placement and invasive blood pressure.

Exclusion Criteria:

• Allergy to local anesthetics (LA).
• Congenital diseases which affect the central nervous system.
• Inability to place an invasive arterial catheter.

Study Plan

How is the study designed?

Design Details

• Observational Models: Case-Only
• Time Perspectives: Prospective

Number of groups / cohorts

1

Cohorts and Interventions

Group / Cohort

Intervention / Treatment

Epidural and arterial catheter; Patients who require placement of an epidural catheter to control postoperative pain and invasive blood pressure will be identified, allowing advanced monitoring using the MostCare Up® device. After identification, the objective of the study will be explained and their consent will be requested to collect the data after the intervention, recording the hemodynamic data before and after the initial bolus of local anesthetic administered: 0.25% levobupivacaine, the dose of which is calculated with the Takasaki formula: 0.05ml x weight (kg) x number of dermatomes to anesthetize.

Drug: Levobupivacaine; Patients who require placement of an epidural catheter to control postoperative pain and invasive blood pressure will be identified, allowing advanced monitoring using the MostCare Up® device. After identification, the objective of the study will be explained and their consent will be requested to collect the data after the intervention, recording the hemodynamic data before and after the initial bolus of local anesthetic administered: 0.25% levobupivacaine, the dose of which is calculated with the Takasaki formula: 0.05ml x weight (kg) x number of dermatomes to anesthetize; Other Names: epidural catheter; invasive arterial catheter

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Hemodynamic repercussion	Drop in blood pressure after epidural levobupivacaine bolus	time zero until 10 minutes
Age related repercussion	Relate the blood pressure drop to the age of the patient	0 years until 12 years

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Epidural level	Asses if the epidural level (lumbar or thoracic) influence the different results	time zero until 10 minutes
Gender	Asses if the gender of the patient influence the different results	time zero until 10 minutes

Collaborators and Investigators

• Sponsor: Hospital Universitario La Fe

Publications and helpful links

General Publications

• Gootman PM, Gootman N, Buckley BJ. Maturation of central autonomic control of the circulation. Fed Proc. 1983 Apr;42(6):1648-55.
• Martinez-Telleria A., Cano Serrano M.E.: Anestesia epidural lumbar. En Anestesia Locorregional en Pediatria, Blanco Vargas D., Reinoso Barbero F., Cruz Tejado J. Ed. ARAN, 2005, Madrid, Cap.9: 129-143.
• Alonso-Inigo JM, Escriba FJ, Carrasco JI, Fas MJ, Argente P, Galvis JM, Llopis JE. Measuring cardiac output in children undergoing cardiac catheterization: comparison between the Fick method and PRAM (pressure recording analytical method). Paediatr Anaesth. 2016 Nov;26(11):1097-1105. doi: 10.1111/pan.12997. Epub 2016 Aug 27.

Study record dates

Study Major Dates

• Study Start (Actual): September 12, 2022
• Primary Completion (Anticipated): April 18, 2023
• Study Completion (Anticipated): September 10, 2023

Study Registration Dates

• First Submitted: September 13, 2022
• First Submitted That Met QC Criteria: September 13, 2022
• First Posted (Actual): September 16, 2022

Study Record Updates

• Last Update Posted (Actual): September 21, 2022
• Last Update Submitted That Met QC Criteria: September 16, 2022
• Last Verified: September 1, 2022

More Information

Terms related to this study

• Keywords: Epidural analgesia; Hemodynamic monitoring; Pediatric surgery
• Additional Relevant MeSH Terms: Physiological Effects of Drugs; Central Nervous System Depressants; Peripheral Nervous System Agents; Sensory System Agents; Anesthetics; Anesthetics, Local; Levobupivacaine
• Other Study ID Numbers: REHAEPP-2022

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: No

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: Yes
• Studies a U.S. FDA-regulated device product: No
• product manufactured in and exported from the U.S.: No