Clinical Trials Logo

Clinical Trial Details — Status: Recruiting

Administrative data

NCT number NCT05115357
Other study ID # 34494/2/21
Secondary ID
Status Recruiting
Phase N/A
First received
Last updated
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
Health authority
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

Study Design


Related Conditions & MeSH terms


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
See also
  Status Clinical Trial Phase
Recruiting NCT05054179 - Pecto-Intercostal Fascial Plane Block Catheter Trial for Reduction of Sternal Pain Phase 2/Phase 3
Completed NCT04051021 - Non-Pharmacological Interventions on Patient Experience and Healthcare Utilization in Adult Cardiac Surgery Patients N/A
Recruiting NCT04604886 - The Consistency of Cardiac Output Measured by Pulmonary Artery Catheter and LiDCO in Cardiac Surgical Patients N/A
Recruiting NCT04075981 - Prevention Atrial Fibrillation by BOTulinum Toxin Injections (BOTAF) Phase 3
Completed NCT04062396 - Comparison of Remowell 2 and Inspire on Delirium and Cognitive Dysfunction N/A
Recruiting NCT04709705 - DMSO Cryopreserved Platelets in Cardiopulmonary Bypass Surgery (CRYPTICS) Phase 2/Phase 3
Not yet recruiting NCT05563662 - SURgical Registry of ENDocarditis EuRope
Withdrawn NCT03289104 - Improving Sternal Healing After Cardiac Surgery: Sternal Wire vs ZIPFIX N/A
Completed NCT04199039 - Effects of Endotracheal Tube Fixation Methods on Hemodynamic Parameters During Endotracheal Suction N/A
Completed NCT03563196 - Diagnosis Of Pulmonary Complications After Cardiac Surgery In Children
Completed NCT02964026 - Study of Clinical Outcomes Associated With the Pulmonary Artery Catheter (PAC) in Cardiac Surgery Patients N/A
Completed NCT02471001 - The Levels of Anaesthetics in Heart Muscle During Heart Surgery N/A
Completed NCT02325726 - RRI Compared With NephroCheckTM to Predict Acute Renal Failure After Cardiac Surgery. N/A
Completed NCT01246947 - Tricuspid Annuloplasty for Moderate Tricuspid Regurgitation Associated With Miral Operation N/A
Completed NCT01151254 - Comparison of Propofol Based Versus Volatile Based Anesthesia and Postoperative Sedation N/A
Completed NCT00821262 - Sevoflurane in Cardiac Surgery Phase 4
Completed NCT00996099 - Continuous Glucose Monitoring Combined With Computer Algorithm for Intensive Insulin Therapy in Cardiosurgical Patients N/A
Completed NCT00617955 - Effects of Aprotinin During Cardiac Surgery/Long Term Death Rates N/A
Completed NCT00336466 - The Erythropoietin NeuroProtective Effect: Assessment in CABG Surgery (TENPEAKS) Phase 2
Completed NCT00337805 - Double Blind Randomized Trial of Saline vs Pentaspan for Resuscitation After Cardiac Surgery Phase 2/Phase 3