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

NCT05774249 | Completed

• 1 other identifier: FMASU R34/2023
• Study Type: interventional
• Target: 40
• Locations: 1 country
• Sites: 1

Brief Summary

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.

Conditions

Postoperative Pain

Outcome Measures

Primary Outcomes (8)

• 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 Outcomes (6)

• 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

Study Arms (2)

Ultrasound guided pectointercostal fascial plane block group

ACTIVE COMPARATOR

using 20 mL of 0.25% bupivacaine with adrenaline 1:400,000

Procedure: Ultrasound guided pecto-intercostal Fascial Plane Block using bupivacaine

control group

PLACEBO COMPARATOR

using 20 mL of normal saline 0.9%

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

Interventions

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 pectointercostal fascial plane block group

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.

control group

Eligibility Criteria

• Age: 30 Years - 70 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

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

You may not qualify if:

• 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

Sponsors & Collaborators

• Ain Shams University: lead

Study Sites (1)

Ain shams university

Cairo, 20, Egypt

Location

MeSH Terms

Conditions

Pain, Postoperative

Condition Hierarchy (Ancestors)

Postoperative Complications; Pathologic Processes; Pathological Conditions, Signs and Symptoms; Pain; Neurologic Manifestations; Signs and Symptoms

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: QUADRUPLE
• Who Masked: PARTICIPANT, CARE PROVIDER, INVESTIGATOR, OUTCOMES ASSESSOR
• Purpose: PREVENTION
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Assistant Professor of Anesthesia

Study Record Dates

• First Submitted: March 4, 2023
• First Posted: March 17, 2023
• Study Start: March 20, 2023
• Primary Completion: March 20, 2023
• Study Completion: July 20, 2023
• Last Updated: July 21, 2023

Record last verified: 2023-07

Locations

EG (1)