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

Overview

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.

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

Study Type

  • Study Type: Interventional
  • Study Design
    • Allocation: Randomized
    • Intervention Model: Parallel Assignment
    • Primary Purpose: Prevention
    • Masking: Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
  • Study Primary Completion Date: March 20, 2023

Detailed Description

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.

Interventions

  • Procedure: Ultrasound guided pecto-intercostal Fascial Plane Block using bupivacaine
    • 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.
  • Procedure: Ultrasound guided pecto-intercostal Fascial Plane Block using normal saline
    • 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.

Arms, Groups and Cohorts

  • Active Comparator: Ultrasound guided pectointercostal fascial plane block group
    • using 20 mL of 0.25% bupivacaine with adrenaline 1:400,000
  • Placebo Comparator: control group
    • using 20 mL of normal saline 0.9%

Clinical Trial Outcome Measures

Primary Measures

  • visual analogue score
    • Time Frame: immediately after extubation
    • 0 (no pain) and 10 (worst possible pain)
  • visual analogue score
    • Time Frame: 1 st hour after extubation
    • 0 (no pain) and 100 (worst possible pain)
  • visual analogue score
    • Time Frame: 2 nd hour after extubation
    • 0 (no pain) and 100 (worst possible pain)
  • visual analogue score
    • Time Frame: 4 th hour after extubation
    • 0 (no pain) and 100 (worst possible pain)
  • visual analogue score
    • Time Frame: 8 th hour after extubation
    • 0 (no pain) and 100 (worst possible pain)
  • visual analogue score
    • Time Frame: 12 th hour after extubation
    • 0 (no pain) and 100 (worst possible pain)
  • visual analogue score
    • Time Frame: 18 th hour after extubation
    • 0 (no pain) and 100 (worst possible pain)
  • visual analogue score
    • Time Frame: 24 th hour after extubation
    • 0 (no pain) and 100 (worst possible pain)

Secondary Measures

  • Total intraoperative opioid consumption
    • Time Frame: during the operation
  • Total postoperative opioid consumption
    • Time Frame: 24 hour after operation
  • Number of patients need postoperative rescue tramadol
    • Time Frame: 24 hours after extubation
  • Time to patient extubation
    • Time Frame: at the end of surgery
  • time for ICU discharge
    • Time Frame: 72 hours after surgery
  • postoperative complication
    • Time Frame: 72 hours after surgery

Participating in This Clinical Trial

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

Gender Eligibility: All

Minimum Age: 30 Years

Maximum Age: 70 Years

Are Healthy Volunteers Accepted: No

Investigator Details

  • Lead Sponsor
    • Ain Shams University
  • Provider of Information About this Clinical Study
    • Principal Investigator: RAMY AHMED, Assistant Professor of Anesthesia – Ain Shams University

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