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

Enhanced Recovery After Cardiac Surgery Clinical Trial

Official title:

The Effect of Ultrasound-guided Bilateral Single Shot Pecto -Intercostal Plane Block on Recovery After On-pump Coronary Bypass Graft Surgery

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT04343105
• Other study ID #: pecto-intercostal plane block
• Status: Completed
• Phase: N/A
• Start date: May 1, 2020
• Est. completion date: July 1, 2022

Study information

• Verified date: August 2022
• Source: Tanta University
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 40
• Est. completion date: July 1, 2022
• Est. primary completion date: June 1, 2022
• Accepts healthy volunteers: No
• Gender: All
• Age group: 40 Years and older

Eligibility

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.

Related Conditions & MeSH terms

• Enhanced Recovery After Cardiac Surgery

Intervention

Procedure:
• 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

Locations

Country	Name	City	State
Egypt	Tarek Abdel Hay	Tanta	El Gharbyia

Sponsors (1)

Lead Sponsor	Collaborator
Tanta University

Country where clinical trial is conducted

Egypt, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	extubation time	duration of mechanical ventilation from the end of anaesthesia till fulfillment weaning criteria and extubated	up to 7 days postoperative
Secondary	Postoperative mean arterial blood pressure measurement	mean arterial blood pressure measurement in mm Hg	within 24 hours postoperative
Secondary	Postoperative heart rate measurement	heart rate measurement in beat/min	within 24 hours postoperative
Secondary	ICU stay duration	from admission of ICU to discharge to ward	up to 7 days postoperative
Secondary	Postoperative pain measurement by numerical rating scale	Numerical Rating Scale for pain that ranged from (0 = no pain) to (10 = intolerable pain). If score is >3 will need analgesia	within 24 hours postoperative