Bilateral Erector Spinae Plane Block for Management of Acute Postoperative Pain After Pediatric Cardiac Surgeries Through a Midline Sternotomy

NCT05142176 | Unknown

• 1 other identifier: 34774/7/21
• Study Type: interventional
• Target: 75
• Locations: 0 countries
• Sites: N/A

Brief Summary

Many analgesic modalities have been investigated in pediatrics. The analgesic efficacy of bilateral ultrasound-guided erector spinae plane block in pediatric patients undergoing open midline sternotomy will be examined. Methods: 60 patients aged 3- 12 years will be randomly assigned into two groups: Control group will receive general anesthesia with bilateral sham erector spinae plane block at the level of T6 transverse process using 0.3 ml/kg normal saline on each side. Erector spinae plane block group will receive bilateral ultrasound-guided erector spinae plane block at the level of T6 transverse process using 0.3 ml/kg bupivacaine 0.25% (on each side) with a maximum dose of 2 mg/kg. The postoperative pain was assessed using Modified Objective Pain Scores (MOPS) which will be evaluated at 0, 1, 2, 4, 6, 8, 10, and 12 hours after extubation, total consumption of intraoperative fentanyl (1µg/kg IV in case of inadequate analgesia), time to first rescue analgesic administration and postoperative paracetamol consumption will be recorded over the first 24 hours postoperatively.

Conditions

Cardiac Surgery

Outcome Measures

Primary Outcomes (7)

• Modified Objective Pain Score (MOPS)0

  A rescue analgesic fentanyl, 0.5 to 1 mg/kg, will be administered when the MOPS score was≥ 4 at rest

  at immediately post extubation.

• Modified Objective Pain Score (MOPS)1

  A rescue analgesic fentanyl, 0.5 to 1 mg/kg, will be administered when the MOPS score was≥ 4 at rest

  at1 hour post extubation.

• Modified Objective Pain Score (MOPS)2

  A rescue analgesic fentanyl, 0.5 to 1 mg/kg, will be administered when the MOPS score was≥ 4 at rest

  at 2 hour post extubation.

• Modified Objective Pain Score (MOPS)3

  A rescue analgesic fentanyl, 0.5 to 1 mg/kg, will be administered when the MOPS score was≥ 4 at rest

  at 4 hour post extubation.

• Modified Objective Pain Score (MOPS)4

  A rescue analgesic fentanyl, 0.5 to 1 mg/kg, will be administered when the MOPS score was≥ 4 at rest

  at 6 hour post extubation.

• Modified Objective Pain Score (MOPS)5

  A rescue analgesic fentanyl, 0.5 to 1 mg/kg, will be administered when the MOPS score was≥ 4 at rest

  at 8 hour post extubation.

• Modified Objective Pain Score (MOPS)6

  A rescue analgesic fentanyl, 0.5 to 1 mg/kg, will be administered when the MOPS score was≥ 4 at rest

  at 12 hour post extubation.

Study Arms (2)

control group

PLACEBO COMPARATOR

will receive general anesthesia with bilateral sham erector spinae plane block at the level of T6 transverse process using 0.3 ml/kg normal saline on each side.

Other: Erector spinae catheters insertion; Drug: Postoperative pain management

Erector spinae plane block group

ACTIVE COMPARATOR

will receive bilateral ultrasound-guided erector spinae plane block at the level of T6 transverse process using 0.3 ml/kg bupivacaine 0.25% (on each side) with a maximum dose of 2 mg/kg.

Other: Erector spinae catheters insertion; Drug: Postoperative pain management

Interventions

Erector spinae catheters insertion OTHER

Ultrasound-Guided ESPB The ESPB will be performed with the child in a right lateral decubitus position under aseptic precautions by a high frequency (6-13 MHz) linear ultrasound transducer

Erector spinae plane block group; control group

Postoperative pain management DRUG

IV acetaminophen 15 mg/kg every 8 hours as a component of multimodal analgesia.

Erector spinae plane block group; control group

Eligibility Criteria

• Age: 3 Years - 12 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Child (0-17)

You may qualify if:

• children undergoing cardiac surgical procedures through midline sternotomy

You may not qualify if:

• The patients with preoperative ejection fraction \<35%
• allergic to the amide type of local anesthetics (LA)
• preoperative inotropic support

Sponsors & Collaborators

• Tanta University: lead

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: DOUBLE
• Who Masked: PARTICIPANT, CARE PROVIDER
• Masking Details: Patients unaware and care giver were unaware about what is injected inthe catheters
• Purpose: OTHER
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Associate professor

Model Details: Bilateral erector spinae block

Study Record Dates

• First Submitted: November 6, 2021
• First Posted: December 2, 2021
• Study Start: February 5, 2022
• Primary Completion: March 30, 2022
• Study Completion: March 30, 2022
• Last Updated: February 1, 2022

Record last verified: 2021-12