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Completed

NCT Number: NCT05774249

Pecto-intercostal Fascial Plane Block for Postoperative Analgesia and Recovery Profile After Off-Pump Coronary Artery Bypass Surgery

Moderate to severe postoperative pain is usually encountered after cardiac surgery.Improper postoperative pain control could have multiple hemodynamic hazards in addition to prolonged postoperative ventilatory support and intensive care unit stay .The safety and efficacy of ultrasound guided chest wall plane blocks has been described for postoperative analgesia after cardiac surgeries.

Study objective: to investigate the effect of adding of pecto-intercostal fascial plane block on the postoperative pain control, perioperative analgesic consumptions and the time for ventilation weaning and intensive care unit discharge in patients who will undergo off-pump Coronary artery bypass surgeries.

Methods: This study patients will be randomly assigned to 2 Groups to receive preoperative ultrasound-guided pecto-intercostal fascial plane block with either 20 mL of 0.25% bupivacaine with adrenaline 1:400,000 or saline bilaterally.

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Key information

Age range

30 year–70 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

Ain shams university

Cairo, 20, Egypt

About this study

After preoperative patients' anesthesia assessment; the study patients (20 in each group) will receive general anesthesia under invasive monitoring of hemodynamics, and oxygen saturation. After anesthesia induction; cannulation of jugular vein and insertion of transoesophageal echocardiography and temperature probe will be done. In block group : while Patients in supine decubitus position,parasternal area will be scanned using high frequency ultrasound linear probe .After identification of ribs with intercostal spaces in between ;the fourth intercostal space will be approached via 10 cm block needle targeting the plane between pectoralis major and external intercostal muscle under ultrasound guidance after which 20 mL of 0.25% bupivacaine with adrenaline 1:400,000 will be administered in increments bilaterally. In control group:Sham Block will be done using 20 mL of normal saline 0.9% bilaterally .

Anesthesia will be maintained with sevoflurane inhalational anesthesia and incremental cisatracurium and fentanyl for intraoperative muscle relaxation and analgesia respectively. Intraoperative anticoagulation will be carried out before revascularization using intravenous heparin titrated according to activated clotting time ,which will be reversed after end of surgery using protamine sulfate.

At the end of surgery patients will be sent to post cardiac surgery intensive care unit . Postoperative analgesia in the form of intravenous paracetamol one gram will be administered on intensive care unit admission then fentanyl based patient controlled analgesia will be started . IV tramadol 1mg/kg as second rescue analgesia will be given if visual analogue scores are still ≥ 4.

Who can participate

Healthy volunteers accepted: No

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

Inclusion criteria

  • NYHA ( New york heart association ) class I- III

Exclusion criteria

  • Parents' refusal to study participation.
  • Patients with poor coronary vessels targets.
  • Patients with poor cardiac systolic function or preoperative hemodynamic unstability
  • Redo coronary artery bypass surgery
  • Intraoperative complication need conversion to on pump surgery
  • Postoperative exploration for bleeding or poor coronary revascularization
  • Advanced COPD(chronic obstructive pulmonary disease) patients.
  • Myopathies and myasthenic patients
  • Allergy to study medications

Treatment and study plan

Ultrasound guided pecto-intercostal Fascial Plane Block using bupivacaine

Procedure

while Patients in supine decubitus position,parasternal area will be scanned using high frequency ultrasound linear probe .After identification of ribs with intercostal spaces in between ;the fourth intercostal space will be approached via 10 cm block needle targeting the plane between pectoralis major and external intercostal muscle under ultrasound guidance after which 20 mL of 0.25% bupivacaine with adrenaline 1:400,000 will be administered in increments bilaterally.

Ultrasound guided pecto-intercostal Fascial Plane Block using normal saline

Procedure

Sham Block will be done while Patients in supine decubitus position,parasternal area will be scanned using high frequency ultrasound linear probe .After identification of ribs with intercostal spaces in between ;the fourth intercostal space will be approached via 10 cm block needle targeting the plane between pectoralis major and external intercostal muscle under ultrasound guidance after which 20 mL of normal saline 0.9 % will be administered bilaterally.

Primary outcomes

  1. visual analogue score

    Time frame: immediately after extubation

    0 (no pain) and 10 (worst possible pain)

  2. visual analogue score

    Time frame: 1 st hour after extubation

    0 (no pain) and 100 (worst possible pain)

  3. visual analogue score

    Time frame: 2 nd hour after extubation

    0 (no pain) and 100 (worst possible pain)

  4. visual analogue score

    Time frame: 4 th hour after extubation

    0 (no pain) and 100 (worst possible pain)

  5. visual analogue score

    Time frame: 8 th hour after extubation

    0 (no pain) and 100 (worst possible pain)

  6. visual analogue score

    Time frame: 12 th hour after extubation

    0 (no pain) and 100 (worst possible pain)

  7. visual analogue score

    Time frame: 18 th hour after extubation

    0 (no pain) and 100 (worst possible pain)

  8. visual analogue score

    Time frame: 24 th hour after extubation

    0 (no pain) and 100 (worst possible pain)

Secondary outcomes

  1. Total intraoperative opioid consumption

    Time frame: during the operation

  2. Total postoperative opioid consumption

    Time frame: 24 hour after operation

  3. Number of patients need postoperative rescue tramadol

    Time frame: 24 hours after extubation

  4. Time to patient extubation

    Time frame: at the end of surgery

  5. time for ICU discharge

    Time frame: 72 hours after surgery

  6. postoperative complication

    Time frame: 72 hours after surgery

Sponsors and collaborators

Lead sponsor

Ain Shams University

Other

Registry information

Official study title

The Value of Adding Pecto-intercostal Fascial Plane Block on the Postoperative Analgesia and Recovery Profile After Off-Pump Coronary Artery Bypass Surgery

Important dates

Study start
2023
Primary completion
2023
Study completion
2023
First posted
Mar 17, 2023
Registry last updated
Jul 21, 2023

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.

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