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

Not Applicable

• Conditions: Pain, Post Operative
• Interventions: Procedure: ultrasound guided regional block

• Registration Number: NCT05323305
• Lead Sponsor: Alexandria University

Brief Summary

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.

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 Timeline

• Status Verified: 2022-03
• Study First Submitted: 2022-03-21
• Study Start: 2022-03-30
• Study First Submitted QC: 2022-04-05
• Last Update Submitted: 2022-04-05
• Study First Posted: 2022-04-12
• Last Update Posted: 2022-04-12
• Primary Completion: 2022-10
• Study Completion: 2022-12

Recruitment & Eligibility

• Status: UNKNOWN
• Sex: All
• Target Recruitment: 60

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 & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
Transversus thoracic Group (n=30)	ultrasound guided regional block	They will receive ultrasound-guided ultrasound-guided transversus thoracic plane block after induction of anesthesia with equal dose before extubation in the intensive care.
Pectointercostal Group (n=30)	ultrasound guided regional block	They will receive ultrasound-guided pectointercostal fascial block after induction of anesthesia with equal dose before extubation in the intensive care.

Primary Outcome Measures

Name	Time	Method
the analgesic effectiveness of the two blocks on midline sternotomy pain,	from end of surgery till discharge from ICU (96 hours)	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."

Secondary Outcome Measures

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

Trial Locations

Locations (1)

Alexandria University Hospitals; 🇪🇬 Alexandria, Egypt