Pain Management of Pecto-intercostal Fascial Block Versus Intravenous Fentanyl After Pediatric Cardiac Surgery

June 22, 2021 updated by: Mansoura University

Ultrasound-Guided Bilateral Pecto-intercostal Fascial Block Versus Intravenous Fentanyl for Postoperative Pain Management After Pediatric Cardiac Surgery A Prospective, Randomized, Controlled Study

Cardiac surgical patients often experience significant postoperative pain at the median sternotomy site.

In pediatric cardiac surgery, the recommended pre bypass dose of fentanyl to blunt the hemodynamic and metabolic stress response is 25-50 µg/kg Today lower doses are often used in order to achieve early extubation at such doses there is no guarantee that the stress response is completely abolished one way to overcome this problem is the use of the local anesthetic technique Regional anesthetic techniques reduce pain for up to 24 hours after cardiac surgery in children.

Pectointercostal fascial block was first described by de la Torre in patients undergoing breast surgery. This novel technique blocks the anterior cutaneous nerve which is a branch of the intercostal nerve that gives sensory supply to the skin.

Study Overview

Status

Not yet recruiting

Conditions

Intervention / Treatment

Detailed Description

The aim of the current study is to detect the effectiveness of pecto-intercostal fascial block in relieving postoperative pain in noncyanotic pediatric patients undergoing elective cardiac surgery the primary goal of this randomized study is to compare the postoperative pain score in the first postoperative 24 hours and to detect total dose of fentanyl requirements. The secondary goals are intraoperative hemodynamic stress response to surgical stimuli, analgesic consumption in the studied groups, cross-clamping and bypass time, time to extubation, intensive care length of stay, and postoperative complications.

Study Type

Interventional

Enrollment (Anticipated)

80

Phase

  • Not Applicable

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Contact

Study Contact Backup

Study Locations

  • Egypt
    • DK
      • Mansoura, DK, Egypt, 050
        • Mansoura University
        • Contact:
        • Contact:
        • Sub-Investigator:
          • Sameh Ghareeb, MD
        • Sub-Investigator:
          • Mohamed A Salama, M.Sec

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

2 years to 12 years (CHILD)

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Description

Inclusion Criteria:

  • On pump
  • Elective repair of congenital simple left to right intracardiac shunt
  • Median sternotomy

Exclusion Criteria:

  • Refusal of their guardians
  • Redo cardiac surgery
  • Previous back injury
  • Previous back surgery
  • Kyphoscoliosis
  • Local infection of the skin and subcutaneous tissue at the site of needle puncture
  • Hypersensitivity to local anesthetics
  • Coagulation disorders
  • Renal disease
  • Hepatic disease
  • Pulmonary disease
  • Heart failure
  • Moderate to severe pulmonary hypertension.

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: PREVENTION
  • Allocation: RANDOMIZED
  • Interventional Model: PARALLEL
  • Masking: SINGLE

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
EXPERIMENTAL: Ultrasound-guided bilateral pecto-intercostal fascial block
Patients will receive bilateral ultrasound-guided pecto-intercostal fascial block
Other: Ultrasound-guided bilateral pecto-intercostal fascial block
- PATIENT IN SUPINE POSITION, SKIN WILL BE DISINFECTED, A HIGH-FREQUENCY LINEAR PROBE WILL BE PLACED PARALLEL TO LONGITUDINAL AXIS OF STERNUM ON LATERAL BORDER AND SCANNED LATERALLY TO IDENTIFY 4TH AND 5TH COSTAL CARTILAGE. THE PECTORALIS MAJOR MUSCLE (PMM), INTERNAL INTERCOSTAL MUSCLE (IIM), TRANSVERSUS THORACIS MUSCLE (TTM), RIBS, AND PLEURA WILL BE IDENTIFIED. COLOR DOPPLER ULTRASONOGRAPHY WILL BE USED TO DETERMINE PERFORATING BRANCHES OF INTERNAL THORACIC ARTERY, WHICH TRAVEL ANTERIORLY THROUGH THE ANTERIOR CHEST WALL, PIERCING THE INTERCOSTAL MUSCLE AND PMM. A 22G NEEDLE WILL BE INSERTED IN PLANE WITH PROBE, IN CAUDAL-TO-CRANIAL DIRECTION UNTIL THE TIP IS POSITIONED IN INTER- FASCIAL PLANE BETWEEN THE PMM AND IIM. NORMAL SALINE WILL BE USED TO DETERMINE CORRECT PLACEMENT OF NEEDLE TIP IN INTER-FASCIAL PLANE, AS SHOWN BY SEPARATION OF FASCIAL LAYERS THEN LOCAL ANESTHETIC WILL BE INJECTED
Drug: Propofol
Propofol anesthesia
Drug: Sevoflurane
Sevoflurane anesthesia
Drug: Atracurium
Intravenous atracurium
Device: ultrasound
ultrasound-guided block
PLACEBO_COMPARATOR: Intravenous fentanyl
Patients will receive only incremental doses of intravenous fentanyl
Drug: Propofol
Propofol anesthesia
Drug: Sevoflurane
Sevoflurane anesthesia
Drug: Atracurium
Intravenous atracurium
Drug: Intravenous fentanyl
In this group, patients will receive only incremental doses of intravenous fentanyl

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Postoperative pain assessment
Time Frame: Postoperative day 1
Postoperative pain will be assessed using the modified objective pain score (OPDS) in children.
Postoperative day 1
Total dose of fentanyl requirements
Time Frame: intraoperative and 24 hrs postoperatively
Total dose of fentanyl requirements
intraoperative and 24 hrs postoperatively

Secondary Outcome Measures

Outcome Measure
Time Frame
Serum cortisol levels
Time Frame: Basal and one-hour postoperatively
Basal and one-hour postoperatively
Heart rate [HR]
Time Frame: before induction of anesthesia (basal value), after induction of anesthesia, after skin incision, after sternotomy, 15 min after CPB and after the closure of sternum
before induction of anesthesia (basal value), after induction of anesthesia, after skin incision, after sternotomy, 15 min after CPB and after the closure of sternum
Invasive mean arterial blood pressure [MAP]
Time Frame: before induction of anesthesia (basal value), after induction of anesthesia, after skin incision, after sternotomy, 15 min after CPB and after the closure of sternum
before induction of anesthesia (basal value), after induction of anesthesia, after skin incision, after sternotomy, 15 min after CPB and after the closure of sternum

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Mansoura University

Investigators

  • Study Director: Mohamed A Ghanem, MD, Assistant professor, MD anesthesia Department, Faculty of Medicine, Mansoura University, Egypt
  • Study Chair: Enas Abd Elmotlb, MD, professor, MD anesthesia Department, Faculty of Medicine, Mansoura University, Egypt

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (ANTICIPATED)

August 1, 2021

Primary Completion (ANTICIPATED)

February 1, 2022

Study Completion (ANTICIPATED)

August 1, 2022

Study Registration Dates

First Submitted

June 13, 2021

First Submitted That Met QC Criteria

June 22, 2021

First Posted (ACTUAL)

June 30, 2021

Study Record Updates

Last Update Posted (ACTUAL)

June 30, 2021

Last Update Submitted That Met QC Criteria

June 22, 2021

Last Verified

June 1, 2021

More Information

Terms related to this study

Additional Relevant MeSH Terms

Other Study ID Numbers

  • MD/ 21.04.462

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

YES

IPD Plan Description

De -identified individual participant data for all primary and secondary outcome measures will be made available

IPD Sharing Time Frame

will be available within 6 months of study completion

IPD Sharing Access Criteria

data access requests will be reviewed by an external independent review panel .requestors will be required to sign a data access agreement

IPD Sharing Supporting Information Type

  • SAP
  • ICF
  • ANALYTIC_CODE
  • CSR

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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