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Clinical Trial Details — Status: Recruiting

Administrative data

NCT number NCT05323305
Other study ID # 0305468
Secondary ID
Status Recruiting
Phase N/A
First received
Last updated
Start date March 30, 2022
Est. completion date December 2022

Study information

Verified date March 2022
Source Alexandria University
Contact Islam Omar, MD
Phone +201227851759
Email i_omar12@alexmed.edu.eg
Is FDA regulated No
Health authority
Study type Interventional

Clinical Trial 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.


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.


Recruitment information / eligibility

Status Recruiting
Enrollment 60
Est. completion date December 2022
Est. primary completion date October 2022
Accepts healthy volunteers No
Gender All
Age group 18 Years and older
Eligibility 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


Related Conditions & MeSH terms


Intervention

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.

Locations

Country Name City State
Egypt Alexandria University Hospitals Alexandria

Sponsors (1)

Lead Sponsor Collaborator
Alexandria University

Country where clinical trial is conducted

Egypt, 

Outcome

Type Measure Description Time frame Safety issue
Primary 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 pulmonary complications atelectasis and pneumonia from end of surgery till discharge from ICU (96 hours)
Secondary length of stay in ICU days from admission till discharge from ICU average 4 days
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