Comparison of Erector Spinae Block and Pecto-Intercostal Facial Block For Enhanced Recovery in Adult Cardiac Surgery

Comparison of Erector Spinae Plane Block and Pecto-Intercostal Facial Plane Block For Enhanced Recovery After Sternotomy in Adult Cardiac Surgery

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.

Study Overview

• Status: Completed
• Conditions: Mitral Regurgitation; Cardiac Septal Defects With Coarctation of the Aorta
• Intervention / Treatment: Procedure: Ultrasound guided Pecto-intercostal- fascial plane block; Drug: Bupivacain; Procedure: Ultrasound guided erector spinae plane block

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.

• Study Type: Interventional
• Enrollment (Actual): 60
• Phase: Phase 2

Contacts and Locations

Study Locations

• Egypt
  • Alexandria, Egypt, 21615
    • Haasan Elhoshy

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 18 years to 50 years (Adult)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: All

Description

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.

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Prevention
• Allocation: Randomized
• Interventional Model: Parallel Assignment
• Masking: Single

Number of Arms

2

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Active Comparator: Group (P)	Procedure: Ultrasound guided Pecto-intercostal- fascial plane block; 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.; Drug: Bupivacain; local anesthetic
Active Comparator: Group (E)	Drug: Bupivacain; local anesthetic; Procedure: Ultrasound guided erector spinae plane block; 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.

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Total dose of fentanyl consumption	Analgesic effectiveness of both blocks in median sternotomy pain	after 1 hour postoperative
Total dose of fentanyl consumption	Analgesic effectiveness of both blocks in median sternotomy pain	after 24 hours postoperative

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
time to extubation	the time from ICU arrival till endotracheal extubation.	after 1 hour of removal of endotracheal tube
ICU Length of stay	length of intensive care unit stay.	after 48 hour postoperative

Collaborators and Investigators

• Sponsor: Alexandria University

Study record dates

Study Major Dates

• Study Start (Actual): May 25, 2022
• Primary Completion (Actual): June 30, 2022
• Study Completion (Actual): July 5, 2022

Study Registration Dates

• First Submitted: July 7, 2022
• First Submitted That Met QC Criteria: July 24, 2022
• First Posted (Actual): July 27, 2022

Study Record Updates

• Last Update Posted (Actual): July 27, 2022
• Last Update Submitted That Met QC Criteria: July 24, 2022
• Last Verified: May 1, 2022

More Information

Terms related to this study

• Additional Relevant MeSH Terms: Heart Diseases; Cardiovascular Diseases; Congenital Abnormalities; Heart Valve Diseases; Heart Defects, Congenital; Cardiovascular Abnormalities; Mitral Valve Insufficiency; Heart Septal Defects; Aortic Coarctation; Physiological Effects of Drugs; Central Nervous System Depressants; Peripheral Nervous System Agents; Sensory System Agents; Anesthetics; Anesthetics, Local; Bupivacaine
• Other Study ID Numbers: 0305600

Drug and device information, study documents

• 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