Pecto-Intercostal Fascial Block Versus Transversus Thoracic Muscle Plane Block in Cardiac Surgery

Efficacy of Ultrasound-Guided Pecto-Intercostal Fascial Block Versus Transversus Thoracic Muscle Plane Block for Postoperative Analgesia in Cardiac Surgery

The aim of this study is to compare the effect of Ultrasound-Guided Pecto-Intercostal Fascial Block versus Transversus Thoracis Muscle Plane Block on Postoperative Pain Analgesia in Cardiac Surgery

Study Overview

• Status: Recruiting
• Conditions: Cardiac Surgery; Postoperative Analgesia; Pecto-Intercostal Fascial Block; Transversus Thoracis Muscle Plane Block
• Intervention / Treatment: Procedure: Pecto-Intercostal Fascial Block; Procedure: Transversus Thoracis Muscle Plane Block

Detailed Description

Perioperative pain management is an essential component of the enhanced recovery pathway in patients undergoing cardiac surgery. The incidence of severe acute postoperative pain after median sternotomy is as high as 49%.

• Study Type: Interventional
• Enrollment (Anticipated): 90
• Phase: Not Applicable

Contacts and Locations

• Study Contact: Name: Abdullah N. Eloraby, MD; Phone Number: +2 0 106 352 5976; Email: eloraby@med.tanta.edu.eg

Study Locations

• Egypt
  • Tanta, Egypt
    • Recruiting
    • Faculty of medicine Tanta university
    • Contact: Abdullah Eloraby, MSc.; Phone Number: +20 1063525976

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 21 years to 60 years (ADULT)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: All

Description

Inclusion Criteria:

• 90 adult patients of both sexes aged (21-60) scheduled for cardio-pulmonary bypass cardiac surgery (valve replacement) with midline sternotomy

Exclusion Criteria:

• Patients' refusal.
• Cognitive impairment.
• History of drug abuse& chronic analgesic use
• History of allergy to local anesthetics.
• Emergency surgery
• Pre-existing major organ dysfunction including hepatic or renal failure, pulmonary insufficiency and left ventricular ejection fraction < 30%
• Known coagulopathy

Study Plan

How is the study designed?

Design Details

• Primary Purpose: TREATMENT
• Allocation: RANDOMIZED
• Interventional Model: PARALLEL
• Masking: DOUBLE

Number of Arms

3

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
NO_INTERVENTION: Intravenous analgesia group; Patients will receive systemic intravenous analgesia only.
EXPERIMENTAL: Pecto-Intercostal Fascial Block (PIFB) group; Patients will receive PIFB on each side with an injection of 19 mL of 0.25% bupivacaine plus 1 ml of 4 mg dexamethasone.	Procedure: Pecto-Intercostal Fascial Block; A high-frequency (7-12 Mhz) linear ultrasound transducer will be placed approximately 2 cm lateral to sternal edge in the 4th or 5th intercostal space. A 22-gauge, 50-mm needle will be inserted in-plane under ultrasound guidance. The needle will be advanced through the pectoralis major muscle, and the drug will be deposited in the pecto-intercostal fascial plane located between the pectoralis major muscle and the external intercostal muscles. The separation of the fascial plane and the spread of the drug could be observed on the ultrasound image .The procedure will be repeated on the other side of sternotomy to achieve bilateral blockade.
EXPERIMENTAL: Transversus Thoracis Muscle Plane Block (TTP) group; Patients will receive TTP on each side with an injection of 19 mL of 0.25% bupivacaine plus 1 ml of 4 mg dexamethasone.	Procedure: Transversus Thoracis Muscle Plane Block; The ultrasound probe will be placed in the longitudinal plane 1 cm lateral to the sterna border. the T4-T5 intercostal space will be identified under US. A parasternal sagittal view of the internal intercostal muscle and the transverses thoracis muscle between the 4th and 5th rib will be visualized above the pleura. A 22-gauge, 50-mm needle will be inserted inplane until the tip of the needle is located in the transversus thoracis muscle plane between the internal intercostal and transversus thoracis muscles . After excluding intravascular and intrapleural placement, local anesthetic will be administered in 5mL aliquots with intermittent aspiration.

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Post-operative pain score	After extubation, patients will be evaluated for pain using numeric rating scale (NRS) score at 0,3,6,12,24 h for pain that ranged from (0 = no pain) to (10 = the worst imaginable pain). If score is ≥ 4, rescue analgesia will be given in the form of fentanyl in a dose of 0.5µg/kg by iv route.	24 hours postoperative

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Total opioid consumption in first 24 hours after cardiac surgery	If the pain score is ≥ 4, rescue analgesia will be given in the form of fentanyl in a dose of 0.5µg/kg by iv route. The time to the first request for analgesia and the total fentanyl dose will be documented.	24 hours Postoperative
duration of mechanical ventilation	Duration of mechanical ventilation in intensive care unit.	24 hours Postoperative
Incidence of complications	Incidence of complications within 24hrs will be recorded as hematoma, pneumothorax and toxicity from local anathesitic.	24 hours Postoperative

Collaborators and Investigators

• Sponsor: Tanta University

Study record dates

Study Major Dates

• Study Start (ACTUAL): December 24, 2021
• Primary Completion (ANTICIPATED): December 1, 2022
• Study Completion (ANTICIPATED): December 1, 2022

Study Registration Dates

• First Submitted: November 3, 2021
• First Submitted That Met QC Criteria: November 3, 2021
• First Posted (ACTUAL): November 10, 2021

Study Record Updates

• Last Update Posted (ACTUAL): February 15, 2022
• Last Update Submitted That Met QC Criteria: February 11, 2022
• Last Verified: February 1, 2022

More Information

Terms related to this study

• Other Study ID Numbers: 34494/2/21

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: YES
• IPD Plan Description: The date will be available under a reasonable request of the corresponding author
• IPD Sharing Time Frame: One year after the end of the study
• IPD Sharing Supporting Information Type: STUDY_PROTOCOL

Drug and device information, study documents

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