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

Cardiac Surgery Clinical Trial

Official title:

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

Clinical Trial Details — Status: Recruiting

Administrative data

• NCT number: NCT05115357
• Other study ID #: 34494/2/21
• Status: Recruiting
• Phase: N/A
• Start date: December 24, 2021
• Est. completion date: December 2022

Study information

• Verified date: February 2022
• Source: Tanta University
• Contact: Abdullah N. Eloraby, MD
• Phone: 0 106 352 5976
• Email: eloraby[@]med.tanta.edu.eg
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial Summary

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

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%.

Recruitment information / eligibility

• Status: Recruiting
• Enrollment: 90
• Est. completion date: December 2022
• Est. primary completion date: December 2022
• Accepts healthy volunteers: No
• Gender: All
• Age group: 21 Years to 60 Years

Eligibility

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

Related Conditions & MeSH terms

• Cardiac Surgery
• Postoperative Analgesia

Intervention

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.
• 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.

Locations

Country	Name	City	State
Egypt	Faculty of Medicine Tanta University	Tanta

Sponsors (1)

Lead Sponsor	Collaborator
Tanta University

Country where clinical trial is conducted

Egypt, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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	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
Secondary	duration of mechanical ventilation	Duration of mechanical ventilation in intensive care unit.	24 hours Postoperative
Secondary	Incidence of complications	Incidence of complications within 24hrs will be recorded as hematoma, pneumothorax and toxicity from local anathesitic.	24 hours Postoperative