Pectointercostal Fascial Plane Block Versus Transversus Thoracic Plane Block In Adult Cardiac Surgery Patients

Ultrasound Guided Pectointercostal Fascial Plane Block Versus Transversus Thoracic Plane Block In Adult Cardiac Surgery Patients: A Comparative Study

The study will be designed to compare the analgesic effect of ultrasound-guided pectointercostal fascial plane block versus tansversus thoracic plane block in adult cardiac surgery.

Study Overview

• Status: Recruiting
• Conditions: Pain, Post Operative
• Intervention / Treatment: Procedure: ultrasound guided regional block

Detailed Description

A prospective study will be carried out in Alexandria Main University Hospitals on 60 adult patients planned for elective cardiac surgery, after approval of the Ethical Committee of Faculty of Medicine, Alexandria, and having an informed written consent taken from patients included in the study. Patients will be categorized into two equal groups; group P (n=30)) will receive ultrasound-guided pectointercostal fascial plane block and group T (n=30) will receive ultrasound-guided transversus thoracic plane block.

All patients will receive the ultrasound-guided block after induction of anesthesia and an equal booster dose of the same block before extubation in the ICU. Patients in both groups will also receive an ultrasound-guided bilateral serratus anterior plane block before extubation.

• Study Type: Interventional
• Enrollment (Anticipated): 60
• Phase: Not Applicable

Contacts and Locations

• Study Contact: Name: Islam Omar, MD; Phone Number: +201227851759; Email: i_omar12@alexmed.edu.eg
• Study Contact Backup: Name: Ibrahim Ibrahim, MD; Phone Number: 01224336786

Study Locations

• Egypt
  • Alexandria, Egypt
    • Recruiting
    • Alexandria University Hospitals

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 18 years and older (Adult, Older Adult)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: All

Description

Inclusion Criteria:

1. Adult patient.
2. Elective cardiac surgery.

Exclusion Criteria:

1. Refusal to participate.
2. Redo or urgent cardiac surgery.
3. Local infection of the skin at the site of needle puncture.
4. Allergy to bupivacaine.
5. Coagulation disorders.
6. Clinically significant liver or kidney disease, heart failure, moderate to severe pulmonary hypertension.
7. when extubation is intentionally planned to be delayed

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Prevention
• Allocation: Randomized
• Interventional Model: Parallel Assignment
• Masking: Quadruple

Number of Arms

2

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Active Comparator: Pectointercostal Group (n=30); They will receive ultrasound-guided pectointercostal fascial block after induction of anesthesia with equal dose before extubation in the intensive care.	Procedure: ultrasound guided regional block; Bupivacaine injection by the use of ultrasound in the pectointercostal fascial plane in one group and in the trasversus thoracic plane in the other group.; Other Names: ultrasound guided nerve block
Active Comparator: Transversus thoracic Group (n=30); They will receive ultrasound-guided ultrasound-guided transversus thoracic plane block after induction of anesthesia with equal dose before extubation in the intensive care.	Procedure: ultrasound guided regional block; Bupivacaine injection by the use of ultrasound in the pectointercostal fascial plane in one group and in the trasversus thoracic plane in the other group.; Other Names: ultrasound guided nerve block

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
the analgesic effectiveness of the two blocks on midline sternotomy pain,	Postoperative pain evaluation after extubation will be done using the Visual Analogue Scale (VAS). a validated, subjective measure for acute and chronic pain. Scores are recorded by making a handwritten mark on a 10-cm line that represents a continuum between 0 "no pain" and 10 "worst pain."	from end of surgery till discharge from ICU (96 hours)

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
pulmonary complications	atelectasis and pneumonia	from end of surgery till discharge from ICU (96 hours)
length of stay in ICU	days from admission till discharge from ICU	average 4 days

Collaborators and Investigators

• Sponsor: Alexandria University
• Investigators: Study Chair: islam Omar, MD, Lecturer of Anaesthesia and surgical intensive care, Faculty of medicine, Alexandria university; Principal Investigator: Ibrahim Ibrahim, MD, Lecturer of Anaesthesia and surgical intensive care, Faculty of medicine, Alexandria university; Study Director: Moustafa Halwag, MD, Lecturer of Anaesthesia and surgical intensive care, Faculty of medicine, Alexandria university

Study record dates

Study Major Dates

• Study Start (Actual): March 30, 2022
• Primary Completion (Anticipated): October 1, 2022
• Study Completion (Anticipated): December 1, 2022

Study Registration Dates

• First Submitted: March 21, 2022
• First Submitted That Met QC Criteria: April 5, 2022
• First Posted (Actual): April 12, 2022

Study Record Updates

• Last Update Posted (Actual): April 12, 2022
• Last Update Submitted That Met QC Criteria: April 5, 2022
• Last Verified: March 1, 2022

More Information

Terms related to this study

• Keywords: Ultrasound, pectointercostal, Cardiac surgery
• Additional Relevant MeSH Terms: Pathologic Processes; Postoperative Complications; Pain; Neurologic Manifestations; Pain, Postoperative
• Other Study ID Numbers: 0305468

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: Yes
• IPD Plan Description: All of the individual participant data collected during the trial, after deidentification
• IPD Sharing Time Frame: Immediately after publication No end date
• IPD Sharing Access Criteria: Any one who wishes to access the data
• IPD Sharing Supporting Information Type: Study Protocol; Statistical Analysis Plan (SAP); Informed Consent Form (ICF); Clinical Study Report (CSR); Analytic Code

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No
• product manufactured in and exported from the U.S.: No