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

NCT05115357 | Unknown

• 1 other identifier: 34494/2/21
• Study Type: interventional
• Target: 90
• Locations: 1 country
• Sites: 1

Brief 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

Conditions

Pecto-Intercostal Fascial Block; Transversus Thoracis Muscle Plane Block; Cardiac Surgery; Postoperative Analgesia

Outcome Measures

Primary Outcomes (1)

• 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 Outcomes (3)

• Total opioid consumption in first 24 hours after cardiac surgery

  24 hours Postoperative

• duration of mechanical ventilation

  24 hours Postoperative

• Incidence of complications

  24 hours Postoperative

Study Arms (3)

Intravenous analgesia group

NO INTERVENTION

Patients will receive systemic intravenous analgesia only.

Pecto-Intercostal Fascial Block (PIFB) group

EXPERIMENTAL

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

Transversus Thoracis Muscle Plane Block (TTP) group

EXPERIMENTAL

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

Interventions

Pecto-Intercostal Fascial Block PROCEDURE

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.

Pecto-Intercostal Fascial Block (PIFB) group

Transversus Thoracis Muscle Plane Block PROCEDURE

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.

Transversus Thoracis Muscle Plane Block (TTP) group

Eligibility Criteria

• Age: 21 Years - 60 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64)

You may qualify if:

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

You may not qualify if:

• 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

Sponsors & Collaborators

• Tanta University: lead

Study Sites (1)

Faculty of Medicine Tanta University

Tanta, Egypt

RECRUITING

Central Study Contacts

Abdullah N. Eloraby, MD

CONTACT

0 106 352 5976; eloraby@med.tanta.edu.eg

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: DOUBLE
• Who Masked: PARTICIPANT, OUTCOMES ASSESSOR
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Assistant lecturer of Anesthesiology and Surgical Intensive Care and Pain Medicine

Study Record Dates

• First Submitted: November 3, 2021
• First Posted: November 10, 2021
• Study Start: December 24, 2021
• Primary Completion: December 1, 2022
• Study Completion: December 1, 2022
• Last Updated: February 15, 2022

Record last verified: 2022-02

Data Sharing

• IPD Sharing: Will share
• Shared Documents: STUDY PROTOCOL
• Time Frame: One year after the end of the study

Locations

EG (1)