Back to resultsPectointercostal Fascial Plane Block Versus Transversus Thoracic Plane Block In Adult Cardiac Surgery Patients
Primary Purpose
Pain, Post Operative
Status
Recruiting
Phase
Not Applicable
Locations
Egypt
Study Type
Interventional
Intervention
ultrasound guided regional block
Sponsored by
About this trial
This is an interventional prevention trial for Pain, Post Operative focused on measuring Ultrasound, pectointercostal, Cardiac surgery
Eligibility Criteria
Inclusion Criteria:
- Adult patient.
- Elective cardiac surgery.
Exclusion Criteria:
- Refusal to participate.
- Redo or urgent cardiac surgery.
- Local infection of the skin at the site of needle puncture.
- Allergy to bupivacaine.
- Coagulation disorders.
- Clinically significant liver or kidney disease, heart failure, moderate to severe pulmonary hypertension.
- when extubation is intentionally planned to be delayed
Sites / Locations
- Alexandria University HospitalsRecruiting
Arms of the Study
Arm 1
Arm 2
Arm Type
Active Comparator
Active Comparator
Arm Label
Pectointercostal Group (n=30)
Transversus thoracic Group (n=30)
Arm Description
They will receive ultrasound-guided pectointercostal fascial block after induction of anesthesia with equal dose before extubation in the intensive care.
They will receive ultrasound-guided ultrasound-guided transversus thoracic plane block after induction of anesthesia with equal dose before extubation in the intensive care.
Outcomes
Primary Outcome Measures
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."
Secondary Outcome Measures
pulmonary complications
atelectasis and pneumonia
length of stay in ICU
days from admission till discharge from ICU
Full Information
1. Study Identification
Unique Protocol Identification Number
NCT05323305
Brief Title
Pectointercostal Fascial Plane Block Versus Transversus Thoracic Plane Block In Adult Cardiac Surgery Patients
Official Title
Ultrasound Guided Pectointercostal Fascial Plane Block Versus Transversus Thoracic Plane Block In Adult Cardiac Surgery Patients: A Comparative Study
Study Type
Interventional
2. Study Status
Record Verification Date
March 2022
Overall Recruitment Status
Recruiting
Study Start Date
March 30, 2022 (Actual)
Primary Completion Date
October 2022 (Anticipated)
Study Completion Date
December 2022 (Anticipated)
3. Sponsor/Collaborators
Responsible Party, by Official Title
Sponsor
Name of the Sponsor
Alexandria University
4. Oversight
Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
No
Product Manufactured in and Exported from the U.S.
No
Data Monitoring Committee
Yes
5. Study Description
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.
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Pain, Post Operative
Keywords
Ultrasound, pectointercostal, Cardiac surgery
7. Study Design
Primary Purpose
Prevention
Study Phase
Not Applicable
Interventional Study Model
Parallel Assignment
Masking
ParticipantCare ProviderInvestigatorOutcomes Assessor
Allocation
Randomized
Enrollment
60 (Anticipated)
8. Arms, Groups, and Interventions
Arm Title
Pectointercostal Group (n=30)
Arm Type
Active Comparator
Arm Description
They will receive ultrasound-guided pectointercostal fascial block after induction of anesthesia with equal dose before extubation in the intensive care.
Arm Title
Transversus thoracic Group (n=30)
Arm Type
Active Comparator
Arm Description
They will receive ultrasound-guided ultrasound-guided transversus thoracic plane block after induction of anesthesia with equal dose before extubation in the intensive care.
Intervention Type
Procedure
Intervention Name(s)
ultrasound guided regional block
Other Intervention Name(s)
ultrasound guided nerve block
Intervention Description
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.
Primary Outcome Measure Information:
Title
the analgesic effectiveness of the two blocks on midline sternotomy pain,
Description
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."
Time Frame
from end of surgery till discharge from ICU (96 hours)
Secondary Outcome Measure Information:
Title
pulmonary complications
Description
atelectasis and pneumonia
Time Frame
from end of surgery till discharge from ICU (96 hours)
Title
length of stay in ICU
Description
days from admission till discharge from ICU
Time Frame
average 4 days
10. Eligibility
Sex
All
Minimum Age & Unit of Time
18 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
Inclusion Criteria:
Adult patient.
Elective cardiac surgery.
Exclusion Criteria:
Refusal to participate.
Redo or urgent cardiac surgery.
Local infection of the skin at the site of needle puncture.
Allergy to bupivacaine.
Coagulation disorders.
Clinically significant liver or kidney disease, heart failure, moderate to severe pulmonary hypertension.
when extubation is intentionally planned to be delayed
Central Contact Person:
First Name & Middle Initial & Last Name or Official Title & Degree
Islam Omar, MD
Phone
+201227851759
Email
i_omar12@alexmed.edu.eg
First Name & Middle Initial & Last Name or Official Title & Degree
Ibrahim Ibrahim, MD
Phone
01224336786
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
islam Omar, MD
Organizational Affiliation
Lecturer of Anaesthesia and surgical intensive care, Faculty of medicine, Alexandria university
Official's Role
Study Chair
First Name & Middle Initial & Last Name & Degree
Ibrahim Ibrahim, MD
Organizational Affiliation
Lecturer of Anaesthesia and surgical intensive care, Faculty of medicine, Alexandria university
Official's Role
Principal Investigator
First Name & Middle Initial & Last Name & Degree
Moustafa Halwag, MD
Organizational Affiliation
Lecturer of Anaesthesia and surgical intensive care, Faculty of medicine, Alexandria university
Official's Role
Study Director
Facility Information:
Facility Name
Alexandria University Hospitals
City
Alexandria
Country
Egypt
Individual Site Status
Recruiting
12. IPD Sharing Statement
Plan to Share IPD
Yes
IPD Sharing Plan Description
All of the individual participant data collected during the trial, after deidentification
IPD Sharing Time Frame
Immediately after publication No end date
IPD Sharing Access Criteria
Any one who wishes to access the data
Learn more about this trial
Pectointercostal Fascial Plane Block Versus Transversus Thoracic Plane Block In Adult Cardiac Surgery Patients
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