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Completed

NCT Number: NCT04343105

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

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.

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Key information

Age range

40 year and older

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

Tarek Abdel Hay

Tanta, El Gharbyia, 31527, Egypt

About this study

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.

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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.

Treatment and study plan

pecto-intercostal plane block

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

Primary outcomes

  1. extubation time

    Time frame: up to 7 days postoperative

    duration of mechanical ventilation from the end of anaesthesia till fulfillment weaning criteria and extubated

Secondary outcomes

  1. Postoperative mean arterial blood pressure measurement

    Time frame: within 24 hours postoperative

    mean arterial blood pressure measurement in mm Hg

  2. Postoperative heart rate measurement

    Time frame: within 24 hours postoperative

    heart rate measurement in beat/min

  3. ICU stay duration

    Time frame: up to 7 days postoperative

    from admission of ICU to discharge to ward

  4. Postoperative pain measurement by numerical rating scale

    Time frame: within 24 hours postoperative

    Numerical Rating Scale for pain that ranged from (0 = no pain) to (10 = intolerable pain). If score is >3 will need analgesia

Sponsors and collaborators

Lead sponsor

Tanta University

Other

Registry information

Official study title

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

Important dates

Study start
2020
Primary completion
2022
Study completion
2022
First posted
Apr 13, 2020
Registry last updated
Aug 10, 2022

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.