NCT03627897: ESP1

ESP Block in Pediatric Patients for Postoperative Analgesia

Completed Phase 4 Last updated 1 February 2022

What this trial tests

Phase 4 trial testing Bupivacain in Opioid Use in 40 participants. Completed in 1 April 2021.

Timeline

1 August 2019

Primary endpoint
1 March 2021

1 April 2021

Quick facts

Lead sponsor	Cukurova University
Phase	Phase 4
Status	Completed
Study type	INTERVENTIONAL
Allocation	randomized
Design	parallel
Masking	triple
Primary purpose	treatment
Enrollment	40
Start date	1 August 2019
Primary completion	1 March 2021
Estimated completion	1 April 2021
Sites	1 location across Turkey (Türkiye)

Drugs / interventions tested

• Bupivacain — full drug profile →
• saline

Conditions studied

• Opioid Use — all drugs for Opioid Use →
• Pain, Postoperative — all drugs for Pain, Postoperative →
• Quality of Life — all drugs for Quality of Life →

Sponsor

Cukurova University

Who can join

Adults 2 to 10, any sex, with Opioid Use or Pain, Postoperative. Patients with the condition only — healthy volunteers not accepted.

Sponsor's own description

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.

Publications & conference data

No peer-reviewed publications indexed yet for this trial. Completed trials usually publish results within 12-18 months.