ESP Block in Pediatric Patients for Postoperative Analgesia (ESP1)

Erector Spinae Plane Block for Postoperative Analgesia in Pediatric Patients Undergoing Cardiac Surgery: A Double-Blind, Randomized, Controlled Study

Pediatric cardiac surgery is associated with moderate to severe postoperative pain that is related to median sternotomy. In a fast-track protocol, used in modern-day cardiac surgical care, early extubation may be facilitated by effective postoperative pain control, which also helps in maintaining hemodynamic stability This prospective, randomized, and double-blind study is designed to examine the efficacy and safety of the ESP block on the postoperative analgesia in pediatric patients after cardiac surgery.

40 pediatric patients aged 2-10 years, undergoing cardiac surgery with median sternotomy will be enrolled. Children received oral premedication of midazolam 0.5 mg/kg. After i.v. access will be obtained, fentanyl 5 µg/kg will be given. Anesthesia will be induced with 2-3 mg/kg propofol and all children will receive rocuronium 0,6 mg/kg for tracheal intubation.Subsequently, fentanyl 5 µg/kg will be administered prior to incision and an additional 5 microg/kg of fentanyl given prior to CPB. Anesthesia will be maintained with %2-3 sevoflurane. Fentanyl 1 µg/kg will be given before skin closure at the end of surgery. Patients were randomly assigned to a study group by the computer generated number table. Children in group B were administered bilateral ESPB with 0.25% bupivacaine, while children in group C did not receive any intervention. Following inhalational induction and endotracheal tube placement, the patient will be turned into a left lateral decubitus position and bilateral ESP block will be performed under aseptic conditions.

ESP block at bilateral side will be performed in the lateral decubitis position and at T5 transverse process level by using 10-MHz liner ultrasound probe. The probe will be located 1 cm lateral to T5 spinous process in longitudinal parasagittal orientation. Simplex A 50mm (B.Braun, Germany) will be inserted by using out of plane technique. The ESP blocks proceed with 0,5 ml/kg of 0,25% bupivacaine (Group B).

Postoperative care: All the patients then will be shifted to the intensive care unit (ICU) after the surgery and managed with the institution's ICU protocol for postoperative pain management and ventilation.The postoperative analgesia will be provided with rescue intravenous (IV) morphine 0.05 mg/kg. Both the groups will receive IV paracetamol 15 mg/kg every 6 hours as a component of multimodal analgesia.

Postoperative sternal wound pain will be judged by the Modified Objectice Pain Scale.

Postoperative sedation levels will be evaluated with Ramsya sedation score.

Study Overview

• Status: Completed
• Conditions: Quality of Life; Pain, Postoperative; Opioid Use
• Intervention / Treatment: Drug: Bupivacain; Drug: saline

Detailed Description

Reducing the pain from surgical procedures performed early in life psychologically reduces the pain experienced by children in subsequent procedures. Pediatric cardiac surgery is associated with moderate to severe postoperative pain that is related to median sternotomy. Pediatric cardiac surgical patients usually undergo multiple surgical interventions and hospital admissions and will benefit from effective pain relief during their initial surgery. In a fast-track protocol, used in modern-day cardiac surgical care, early extubation may be facilitated by executive postoperative pain control, which also helps in maintaining hemodynamic stability.

Neuraxial analgesia techniques are effective for sternotomy pain. However cardiac surgery procedures potentially require cardiopulmonary bypass (CPB) and systemic anticoagulation, thus increasing the epidural hematoma risk. Erector spinae plane (ESP) block appears to provide adequate regional analgesia for multiple dermatomal levels covering the sternum without increasing the risks associated with neuraxial blocks.

This prospective, randomized, and double-blind study is designed to examine the efficacy and safety of the ESP block on the postoperative analgesia in pediatric patients after cardiac surgery. We hypothesized that the ESP block significantly improves pain control, as evidenced by the reduced need for systemic postoperative analgesics.

METHOD After obtaining approval from the Institutional Review Boards at Çukurova University Medical Faculty, 40 pediatric patients aged 2-10 years, undergoing cardiac surgery with median sternotomy will be enrolled. Parental consent and patient assent from patients of an appropriate age will be obtained. Children with a preoperative ejection fraction<35%, a ventricular arrhythmia/dysrhythmia, a low cardiac output syndrome, a redo or an emergency surgery, a scoliosis or other anatomic contraindication to ESPB, a history of bleeding diathesis, an anticoagulant drug use at the time of the block and with known allergies to any of the study drugs will be excluded from the study.

Anesthesia Children received oral premedication of midazolam 0.5 mg/kg. After i.v. access will be obtained, fentanyl 5 µg/kg will be given. Anesthesia will be induced with 2-3 mg/kg propofol and all children will receive rocuronium 0,6 mg/kg for tracheal intubation. After tracheal intubation, an arterial line, central venous catheter, and urinary catheter will be inserted. Subsequently, fentanyl 5 µg/kg will be administered prior to incision and an additional 5 microg/kg of fentanyl given prior to CPB. Anesthesia will be maintained with %2-3 sevoflurane. Fentanyl 1 µg/kg will be given before skin closure at the end of surgery.

Intervention Patients were randomly assigned to a study group by the computer generated number table. Children in group B will be administered bilateral ESPB with 0.25% bupivacaine, while children in group C did not receive any intervention. The anesthesia resident observing the patient in the postperative period and the intensive care unit staff giving postoperative care will be blind to the study protocol.

Following anesthesia induction and endotracheal tube placement, the patient will be turned into a left lateral decubitus position and bilateral ESP block will be performed under aseptic conditions.

ESP block at bilateral side will be performed in the lateral decubitis position and at T5 transverse process level by using 10-MHz liner ultrasound probe. The probe will be located 1 cm lateral to T5 spinous process in longitudinal parasagittal orientation. Simplex A 50mm (B.Braun, Germany) will be inserted by using out of plane technique. The ESP blocks proceed with 0,5 ml/kg of 0,25% bupivacaine (Group B). The injection will be applied after the confirmation of location by hydrodissection developed anterior to erector spinae muscle with 1-2 ml of local anesthetic solution.

Postoperative care All the patients then will be shifted to the intensive care unit (ICU) after the surgery and managed with the institution's ICU protocol for postoperative pain management and ventilation.The postoperative analgesia will be provided with rescue intravenous (IV) morphine 0.05 mg/kg. Both the groups will receive IV paracetamol 15 mg/kg every 6 hours as a component of multimodal analgesia.

Postoperative sternal wound pain will be judged by the Modified Objectice Pain Scale.

Postoperative sedation levels will be evaluated with Ramsay sedation score.

• Study Type: Interventional
• Enrollment (Actual): 40
• Phase: Phase 4

Contacts and Locations

Study Locations

• Turkey
  • In The USA Or Canada, Please Select...
    • Adana, In The USA Or Canada, Please Select..., Turkey, 01330
      • Feri̇de Karacaer

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 2 years to 10 years (Child)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: All

Description

Inclusion Criteria:

• 2-10 years old patients
• Pediatric patients undergoing cardiac surgery with median sternotomy

Exclusion Criteria:

• A history of develop mental delay or mental retardation
• Any other heart defect
• Known allergy to any local anesthetic
• Clinically significant liver or renal disease.

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Treatment
• Allocation: Randomized
• Interventional Model: Parallel Assignment
• Masking: Triple

Number of Arms

2

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Other: Control group	Drug: saline; No drugs or interventions were administered to the control group.
Experimental: Regional analgesia group; ESP block at bilateral side will be performed in the lateral decubitis position and at T5 transverse process level by using 10-MHz liner ultrasound probe. The probe will be located 1 cm lateral to T5 spinous process in longitudinal parasagittal orientation. Simplex A 50mm (B.Braun, Germany) will be inserted by using out of plane technique. The ESP blocks proceed with 0,5 ml/kg of 0,25% bupivacaine	Drug: Bupivacain; The erector spinae plane blocks proceed with 0,5 ml/kg of 0,25% bupivacain (Group B).

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Morphine consumption	Total consumption of rescue analgesia by morphine (mcg/kg)	24 hours after arrival in Intensive care unit

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Pain assesment in infant/toddlers	Pain assessment will be based on Modified objective pain scale	24 hours after arrival in intensive care unit

Collaborators and Investigators

• Sponsor: Cukurova University
• Investigators: Principal Investigator: FERİDE KARACAER, Specialist, Çukurova university

Publications and helpful links

General Publications

• De la Cuadra-Fontaine JC, Concha M, Vuletin F, Arancibia H. Continuous Erector Spinae Plane block for thoracic surgery in a pediatric patient. Paediatr Anaesth. 2018 Jan;28(1):74-75. doi: 10.1111/pan.13277. No abstract available.
• Barr AM, Tutungi E, Almeida AA. Parasternal intercostal block with ropivacaine for pain management after cardiac surgery: a double-blind, randomized, controlled trial. J Cardiothorac Vasc Anesth. 2007 Aug;21(4):547-53. doi: 10.1053/j.jvca.2006.09.003. Epub 2006 Dec 22.

Study record dates

Study Major Dates

• Study Start (Actual): August 1, 2019
• Primary Completion (Actual): March 1, 2021
• Study Completion (Actual): April 1, 2021

Study Registration Dates

• First Submitted: August 4, 2018
• First Submitted That Met QC Criteria: August 8, 2018
• First Posted (Actual): August 14, 2018

Study Record Updates

• Last Update Posted (Actual): February 1, 2022
• Last Update Submitted That Met QC Criteria: January 17, 2022
• Last Verified: January 1, 2022

More Information

Terms related to this study

• Additional Relevant MeSH Terms: Pathologic Processes; Postoperative Complications; Pain; Neurologic Manifestations; Pain, Postoperative; Physiological Effects of Drugs; Central Nervous System Depressants; Peripheral Nervous System Agents; Sensory System Agents; Anesthetics; Anesthetics, Local; Bupivacaine
• Other Study ID Numbers: ESPediatrics

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: No
• Studies a U.S. FDA-regulated device product: No