Pecto-intercostal Plane Block in On-pump Coronary Bypass Graft Surgery

NCT ID: NCT04343105

Last Updated: 2022-08-10

Basic Information

• Recruitment Status: COMPLETED
• Clinical Phase: NA
• Total Enrollment: 40 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2020-05-01
• Study Completion Date: 2022-07-01

Brief Summary

Fast track and ultrafast track cardiac anaesthesia appear to demonstrate improved outcomes without compromising patient safety. Their benefits include shorter intensive care unit stays, reduced duration of mechanical ventilation and lower health care costs. Regional anesthesia has played an important role in enhanced recovery pathways for other surgical services and allows for reduced systemic opioid use during intraoperative and postoperative care This study will be conducted to evaluate the effectiveness and safety of ultrasound guided bilateral single shot pecto - intercostal plane block on recovery after on pump CABG surgery.

Detailed Description

Fast-track anesthesia (FTA) is a procedure that enables extubation in intensive care unit (ICU) within 6 h after surgery to facilitate the recovery of consciousness and autonomous breathing. It has been safely applied to cardiac surgery since the 1990s.

FTA is feasible and safe and reduces the occurrence of ventilator induced complications, thereby decreasing ICU stay, resource use and cost.

Ultra-fast tract anesthesia (UFTA) was developed after fast-track anesthesia to further optimize the use of medical resource. With UFTA, extubation is performed immediately or within 1 h after surgery in the operating room. The benefits of UFTA include lower incidence of postoperative complications, better hemodynamic performance, shorter ICU stay.

Fast track and ultrafast track cardiac anaesthesia can be achieved by reduced opioid doses or opioid free with multimodal analgesia augmented with bilateral regional anaesthesia as pecto - intercostal plane block.

Fast track and ultrafast track cardiac anaesthesia appear to demonstrate improved outcomes without compromising patient safety. Their benefits include shorter intensive care unit stays, reduced duration of mechanical ventilation and lower health care costs. Regional anesthesia has played an important role in enhanced recovery pathways for other surgical services and allows for reduced systemic opioid use during intraoperative and postoperative care.

The anteromedial chest wall (i.e., the sternum and parasternal region) is innervated by the anterior branches of the intercostal nerves. These terminal anterior branches ascend in the parasternal region through the intercostal and pectoralis major muscles to innervate the superficial tissues. They can thus be targeted in one of two fascial planes: either deep into intercostal muscles and superficial to transversus thoracis muscles or superficial to the intercostal muscles and deep into pectoralis major muscle.

The sensory innervation of the thorax is provided by the 2nd through 6th intercostal nerves. The intercostal nerves terminate in anterior cutaneous branches, which divide into medial and lateral branches, providing innervation to the anterior chest wall. A pecto - intercostal nerve block targets the anterior intercostal nerves just lateral to the sternum in the interfascial plane between pectoralis major muscle and external intercostal muscle.

Conditions

Enhanced Recovery After Cardiac Surgery

Study Design

• Allocation Method: RANDOMIZED
• Intervention Model: PARALLEL
• Primary Study Purpose: SUPPORTIVE_CARE
• Blinding Strategy: QUADRUPLE

Study Groups

sham group

will receive sham bilateral ultrasounded guided single shot pecto-intercostal plane block between 3rd and 4th rib 2 cm lateral to sternal border for each side after induction of anaesthesia in supine position

Group Type: SHAM_COMPARATOR

pecto-intercostal plane block

Intervention Type: PROCEDURE

under ultrasound guidance, pecto-intercostal plane block will be performed between 3rd and 4th rib 2 cm lateral to sternal border in supine position at the interfascial plane between pectoralis major muscle and intercostal muscles

real group

will receive real bilateral ultrasounded guided single shot pecto-intercostal plane block between 3rd and 4th rib 2 cm lateral to sternal border for each side after induction of anaesthesia in supine position with 10 ml bupivacaine 0.5% + 10 ml lidocaine 2% in total volume 20 ml for each side.

Group Type: EXPERIMENTAL

pecto-intercostal plane block

Intervention Type: PROCEDURE

under ultrasound guidance, pecto-intercostal plane block will be performed between 3rd and 4th rib 2 cm lateral to sternal border in supine position at the interfascial plane between pectoralis major muscle and intercostal muscles

Interventions

pecto-intercostal plane block

under ultrasound guidance, pecto-intercostal plane block will be performed between 3rd and 4th rib 2 cm lateral to sternal border in supine position at the interfascial plane between pectoralis major muscle and intercostal muscles

Intervention Type: PROCEDURE

Eligibility Criteria

Inclusion Criteria

• Patient aged more than 40 years old.
• scheduled for elective open-heart surgery including CABG with on pump cardiopulmonary bypass.

Exclusion Criteria

• Patients with severe pulmonary hypertension and / or heart failure.
• Emergency or combined cardiac surgery.
• Patients with preoperative use of intra-aortic balloon pump.
• Patients with poor ventricular function less than 45 %.
• Patients with preoperative uncontrolled arrhythmia.
• Patients with moderate to severe hepatic and / or renal dysfunction.
• Patients with anticipated difficult airway.
• Severe obstructive and / or restrictive pulmonary function test.

• Minimum Eligible Age: 40 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

Tanta University

OTHER

Sponsor Role: lead

Responsible Party

tarek abdel hay mostafa

principle investigator

Responsibility Role: PRINCIPAL_INVESTIGATOR

Locations

Tarek Abdel Hay

Tanta, El Gharbyia, Egypt

Countries

Egypt

Other Identifiers

pecto-intercostal plane block

Identifier Type: -

Identifier Source: org_study_id