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

Not Applicable

• Conditions: Cardiac Surgery; Pecto-Intercostal Fascial Block; Postoperative Analgesia; Transversus Thoracis Muscle Plane Block
• Interventions: Procedure: Transversus Thoracis Muscle Plane Block; Procedure: Pecto-Intercostal Fascial Block

• Registration Number: NCT05115357
• Lead Sponsor: Tanta University

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

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 Timeline

• Study First Submitted: 2021-11-03
• Study First Submitted QC: 2021-11-03
• Study First Posted: 2021-11-10
• Study Start: 2021-12-24
• Status Verified: 2022-02
• Last Update Submitted: 2022-02-11
• Last Update Posted: 2022-02-15
• Primary Completion: 2022-12
• Study Completion: 2022-12

Recruitment & Eligibility

• Status: UNKNOWN
• Sex: All
• Target Recruitment: 90

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 & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
Transversus Thoracis Muscle Plane Block (TTP) group	Transversus Thoracis Muscle Plane Block	Patients will receive TTP on each side with an injection of 19 mL of 0.25% bupivacaine plus 1 ml of 4 mg dexamethasone.
Pecto-Intercostal Fascial Block (PIFB) group	Pecto-Intercostal Fascial Block	Patients will receive PIFB on each side with an injection of 19 mL of 0.25% bupivacaine plus 1 ml of 4 mg dexamethasone.

Primary Outcome Measures

Name	Time	Method
Post-operative pain score	24 hours postoperative	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.

Secondary Outcome Measures

Name	Time	Method
Total opioid consumption in first 24 hours after cardiac surgery	24 hours Postoperative	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.
duration of mechanical ventilation	24 hours Postoperative	Duration of mechanical ventilation in intensive care unit.
Incidence of complications	24 hours Postoperative	Incidence of complications within 24hrs will be recorded as hematoma, pneumothorax and toxicity from local anathesitic.

Trial Locations

Locations (1)

Faculty of Medicine Tanta University; 🇪🇬 Tanta, Egypt