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

The Value of Adding Pecto-intercostal Fascial Plane Block on the 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.

Study Overview

• Status: Completed
• Conditions: Postoperative Pain
• Intervention / Treatment: Procedure: Ultrasound guided pecto-intercostal Fascial Plane Block using bupivacaine; Procedure: Ultrasound guided pecto-intercostal Fascial Plane Block using normal saline

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.

• Study Type: Interventional
• Enrollment (Actual): 40
• Phase: Not Applicable

Contacts and Locations

Study Locations

• Egypt
  • Cairo, Egypt, 20
    • Ain Shams University

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 30 years to 70 years (Adult, Older Adult)
• Accepts Healthy Volunteers: No

Description

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

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Prevention
• Allocation: Randomized
• Interventional Model: Parallel Assignment
• Masking: Quadruple

Number of Arms

2

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Active Comparator: Ultrasound guided pectointercostal fascial plane block group; using 20 mL of 0.25% bupivacaine with adrenaline 1:400,000	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.
Placebo Comparator: control group; using 20 mL of normal saline 0.9%	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.

What is the study measuring?

Primary Outcome Measures

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

Secondary Outcome Measures

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

Collaborators and Investigators

• Sponsor: Ain Shams University

Study record dates

Study Major Dates

• Study Start (Actual): March 20, 2023
• Primary Completion (Actual): March 20, 2023
• Study Completion (Actual): July 20, 2023

Study Registration Dates

• First Submitted: March 4, 2023
• First Submitted That Met QC Criteria: March 15, 2023
• First Posted (Actual): March 17, 2023

Study Record Updates

• Last Update Posted (Actual): July 21, 2023
• Last Update Submitted That Met QC Criteria: July 20, 2023
• Last Verified: July 1, 2023

More Information

Terms related to this study

• Additional Relevant MeSH Terms: Pathologic Processes; Postoperative Complications; Pain; Neurologic Manifestations; Pain, Postoperative; Physiological Effects of Drugs; Central Nervous System Depressants; Peripheral Nervous System Agents; Sensory System Agents; Anesthetics; Anesthetics, Local; Bupivacaine
• Other Study ID Numbers: FMASU R34/2023

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No