Comparison of Erector Spinae Block and Pecto-Intercostal Facial Block For Enhanced Recovery in Adult Cardiac Surgery
Primary Purpose
Cardiac Septal Defects With Coarctation of the Aorta, Mitral Regurgitation
Status
Completed
Phase
Phase 2
Locations
Egypt
Study Type
Interventional
Intervention
Ultrasound guided Pecto-intercostal- fascial plane block
Ultrasound guided erector spinae plane block
Bupivacain
Sponsored by
About this trial
This is an interventional prevention trial for Cardiac Septal Defects With Coarctation of the Aorta
Eligibility Criteria
Inclusion Criteria:
- adult patients of either sex
- aged 18-50 years
- undergoing elective cardiac surgery via median sternotomy
Exclusion Criteria:
- refusal to participate,
- redo
- 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
- extubation is intentionally planned to be delayed.
Sites / Locations
- Haasan Elhoshy
Arms of the Study
Arm 1
Arm 2
Arm Type
Active Comparator
Active Comparator
Arm Label
Group (P)
Group (E)
Arm Description
Outcomes
Primary Outcome Measures
Total dose of fentanyl consumption
Analgesic effectiveness of both blocks in median sternotomy pain
Total dose of fentanyl consumption
Analgesic effectiveness of both blocks in median sternotomy pain
Secondary Outcome Measures
time to extubation
the time from ICU arrival till endotracheal extubation.
ICU Length of stay
length of intensive care unit stay.
Full Information
1. Study Identification
Unique Protocol Identification Number
NCT05475561
Brief Title
Comparison of Erector Spinae Block and Pecto-Intercostal Facial Block For Enhanced Recovery in Adult Cardiac Surgery
Official Title
Comparison of Erector Spinae Plane Block and Pecto-Intercostal Facial Plane Block For Enhanced Recovery After Sternotomy in Adult Cardiac Surgery
Study Type
Interventional
2. Study Status
Record Verification Date
May 2022
Overall Recruitment Status
Completed
Study Start Date
May 25, 2022 (Actual)
Primary Completion Date
June 30, 2022 (Actual)
Study Completion Date
July 5, 2022 (Actual)
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
5. Study Description
Brief Summary
The current study is designed to compare the perioperative analgesic efficacy of Erector spinae plane block (ESPB) and Pecto-intercostal-fascial plane block (PIFB) in adults undergoing cardiac surgery via median sternotomy.
The primary outcome measure will be the analgesic effectiveness of both blocks in median sternotomy pain, while the secondary outcome measures will be time to extubation, and length of intensive care unit stay.
Detailed Description
The patients will undergo the same preoperative preparation, intraoperative monitoring, and anesthetic technique. Fentanyl (2 μg/kg) will be given with induction of anesthesia, and additional increments of fentanyl 2 μg/kg will be administered if mean arterial blood pressure or heart rate rise in response to stressful surgical stimuli greater than 20% above baseline.
All surgeries will be performed through median sternotomy, with the same cardiopulmonary bypass and myocardial protection technique. At the end of surgery, all anesthetics will be discontinued, and patients will be transferred to the ICU where they will be committed to a mechanical ventilator.
the two blocks will be performed using Linear -Array ultrasound transducer probe (SONOSITE M-TURBO). After standard chest skin disinfection, the transducer will be covered with a sterile sleeve.
he two blocks will be performed using Linear -Array ultrasound transducer probe (SONOSITE M-TURBO). After standard chest skin disinfection, the transducer will be covered with a sterile sleeve.
Ultrasound guided Pecto-intercostal- fascial plane block:
The block will be performed while the patient in supine position after induction of general anesthesia and before skin incision. The probe of the ultrasound will be placed at 2 cm lateral to the lateral sternal border at 5th and 6th rib. On the surface plane subcutaneous tissue is identified, while Pectoralis major muscle, Intercostal muscles and ribs are seen in intermediate plane and lung along with pleura are identified in deep plane. A 22-gauge, 80-mm short bevel echogenic needle is used and advanced in in-plane manner, in a caudal-to-cranial direction, until the tip of the needle is located in the fascial plane between the pectoralis major and internal intercostal muscle, where the local anesthetic will be injected. As the drug will be injected, a hydro dissection of the plane is checked for. At this point, color doppler ultrasonography will be used to help identify the internal thoracic artery and its branches that pass through the plan.
Ultrasound guided erector spinae plane block:
The block will be done while the patient is in the sitting position before induction of general anesthesia. A high-frequency linear ultrasound transducer will be placed in a longitudinal orientation 3 cm lateral to the T6 spinous process corresponding to the T5 transverse process. Three muscles trapezius (uppermost), rhomboids major (middle), and erector spinae (lowermost) will be identified superior to the hyperechoic transverse process. Local infiltration with 2% of lignocaine at the site of needle insertion will be done. Using in-plane approach a 22 G short bevel needle will be inserted in caudal-cephalad direction, until the tip is deep to erector spinae muscle, as evidenced by visible hydro dissection below the muscle plane. A 20 ml of 0.25% plain bupivacaine will be injected on each side.
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Cardiac Septal Defects With Coarctation of the Aorta, Mitral Regurgitation
7. Study Design
Primary Purpose
Prevention
Study Phase
Phase 2
Interventional Study Model
Parallel Assignment
Masking
Participant
Allocation
Randomized
Enrollment
60 (Actual)
8. Arms, Groups, and Interventions
Arm Title
Group (P)
Arm Type
Active Comparator
Arm Title
Group (E)
Arm Type
Active Comparator
Intervention Type
Procedure
Intervention Name(s)
Ultrasound guided Pecto-intercostal- fascial plane block
Intervention Description
The probe of the ultrasound will be placed at 2 cm lateral to the lateral sternal border at 5th and 6th rib. On the surface plane subcutaneous tissue is identified, while Pectoralis major muscle, Intercostal muscles and ribs are seen in intermediate plane and lung along with pleura are identified in deep plane. A 22-gauge, 80-mm short bevel echogenic needle is used and advanced in in-plane manner, in a caudal-to-cranial direction, until the tip of the needle is located in the fascial plane between the pectoralis major and internal intercostal muscle, where the local anesthetic will be injected.
Intervention Type
Procedure
Intervention Name(s)
Ultrasound guided erector spinae plane block
Intervention Description
A high-frequency linear ultrasound transducer will be placed in a longitudinal orientation 3 cm lateral to the T6 spinous process corresponding to the T5 transverse process. Three muscles trapezius (uppermost), rhomboids major (middle), and erector spinae (lowermost) will be identified superior to the hyperechoic transverse process.Local infiltration with 2% of lignocaine at the site of needle insertion will be done. Using in-plane approach a 22 G short bevel needle will be inserted in caudal-cephalad direction, until the tip is deep to erector spinae muscle, as evidenced by visible hydro dissection below the muscle plane. A 20 ml of 0.25% plain bupivacaine will be injected on each side.
Intervention Type
Drug
Intervention Name(s)
Bupivacain
Intervention Description
local anesthetic
Primary Outcome Measure Information:
Title
Total dose of fentanyl consumption
Description
Analgesic effectiveness of both blocks in median sternotomy pain
Time Frame
after 1 hour postoperative
Title
Total dose of fentanyl consumption
Description
Analgesic effectiveness of both blocks in median sternotomy pain
Time Frame
after 24 hours postoperative
Secondary Outcome Measure Information:
Title
time to extubation
Description
the time from ICU arrival till endotracheal extubation.
Time Frame
after 1 hour of removal of endotracheal tube
Title
ICU Length of stay
Description
length of intensive care unit stay.
Time Frame
after 48 hour postoperative
10. Eligibility
Sex
All
Minimum Age & Unit of Time
18 Years
Maximum Age & Unit of Time
50 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
Inclusion Criteria:
adult patients of either sex
aged 18-50 years
undergoing elective cardiac surgery via median sternotomy
Exclusion Criteria:
refusal to participate,
redo
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
extubation is intentionally planned to be delayed.
Facility Information:
Facility Name
Haasan Elhoshy
City
Alexandria
ZIP/Postal Code
21615
Country
Egypt
12. IPD Sharing Statement
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Comparison of Erector Spinae Block and Pecto-Intercostal Facial Block For Enhanced Recovery in Adult Cardiac Surgery
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