Clinical trial NCT04343105: Pecto-intercostal Plane Block in On-pump Coronary Bypass Graft Surgery
Official title: The Effect of Ultrasound-guided Bilateral Single Shot Pecto -Intercostal Plane Block on Recovery After On-pump Coronary Bypass Graft Surgery
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Enhanced Recovery After Cardiac Surgery
Lead sponsor: Tanta University
Sponsor class: OTHER
First posted: 2020-04-13
Enrollment: 40
Sex: ALL
Minimum age (years): 40
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: SUPPORTIVE_CARE

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.

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.

Primary outcomes:
measure: extubation time
timeFrame: up to 7 days postoperative
Secondary outcomes:
measure: Postoperative mean arterial blood pressure measurement
timeFrame: within 24 hours postoperative
measure: Postoperative heart rate measurement
timeFrame: within 24 hours postoperative
measure: ICU stay duration
timeFrame: up to 7 days postoperative
measure: Postoperative pain measurement by numerical rating scale
timeFrame: within 24 hours postoperative
Other outcomes:
Locations:
city: Tanta
country: Egypt
facility: Tarek Abdel Hay
state: El Gharbyia
Study officials:
References: