ESP Block in Pediatric Patients for Postoperative Analgesia

NCT03627897 | Completed Phase 4

• 1 other identifier: ESPediatrics
• Study Type: interventional
• Target: 40
• Locations: 1 country
• Sites: 1

Brief Summary

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.

Conditions

Opioid Use; Pain, Postoperative; Quality of Life

Outcome Measures

Primary Outcomes (1)

• Morphine consumption

  Total consumption of rescue analgesia by morphine (mcg/kg)

  24 hours after arrival in Intensive care unit

Secondary Outcomes (1)

• Pain assesment in infant/toddlers

  24 hours after arrival in intensive care unit

Study Arms (2)

Regional analgesia group

EXPERIMENTAL

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

Control group

OTHER

Drug: saline

Interventions

Bupivacain DRUG

The erector spinae plane blocks proceed with 0,5 ml/kg of 0,25% bupivacain (Group B).

Regional analgesia group

saline DRUG

No drugs or interventions were administered to the control group.

Control group

Eligibility Criteria

• Age: 2 Years - 10 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Child (0-17)

You may qualify if:

• years old patients
• Pediatric patients undergoing cardiac surgery with median sternotomy

You may not qualify if:

• 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.

Sponsors & Collaborators

• Cukurova University: lead

Study Sites (1)

Feri̇de Karacaer

Adana, In the USA Or Canada, Please Select..., 01330, Turkey (Türkiye)

Location

Related Publications (2)

• 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.

  PMID: 29226529 RESULT

• 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.

  PMID: 17678782 RESULT

MeSH Terms

Conditions

Pain, Postoperative

Interventions

Bupivacaine; Sodium Chloride

Condition Hierarchy (Ancestors)

Postoperative Complications; Pathologic Processes; Pathological Conditions, Signs and Symptoms; Pain; Neurologic Manifestations; Signs and Symptoms

Intervention Hierarchy (Ancestors)

Anilides; Amides; Organic Chemicals; Aniline Compounds; Amines; Chlorides; Hydrochloric Acid; Chlorine Compounds; Inorganic Chemicals; Sodium Compounds

Study Officials

• FERİDE KARACAER, Specialist

  Cukurova University

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: phase 4
• Allocation: RANDOMIZED
• Masking: TRIPLE
• Who Masked: PARTICIPANT, CARE PROVIDER, OUTCOMES ASSESSOR
• Masking Details: The children will randomly assigned into two study groups by a computer-generated random number list. The children in group B will be administered bilateral ESPB with 0.25% bupivacaine by non-blinded researcher to the study groups), while the children in group C will be not administered any intervention.
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Principal investigator

Study Record Dates

• First Submitted: August 4, 2018
• First Posted: August 14, 2018
• Study Start: August 1, 2019
• Primary Completion: March 1, 2021
• Study Completion: April 1, 2021
• Last Updated: February 1, 2022

Record last verified: 2022-01

Data Sharing

• IPD Sharing: Will not share

Locations

TU (1)