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

Postoperative Pain Clinical Trial

Official title:

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT05774249
• Other study ID #: FMASU R34/2023
• Status: Completed
• Phase: N/A
• Start date: March 20, 2023
• Est. completion date: July 20, 2023

Study information

• Verified date: July 2023
• Source: Ain Shams University
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 40
• Est. completion date: July 20, 2023
• Est. primary completion date: March 20, 2023
• Accepts healthy volunteers: No
• Gender: All
• Age group: 30 Years to 70 Years

Eligibility

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

Related Conditions & MeSH terms

• Pain, Postoperative
• Postoperative Pain

Intervention

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.
• 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.

Locations

Country	Name	City	State
Egypt	Ain shams university	Cairo

Sponsors (1)

Lead Sponsor	Collaborator
Ain Shams University

Country where clinical trial is conducted

Egypt, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	visual analogue score	0 (no pain) and 10 (worst possible pain)	immediately after extubation
Primary	visual analogue score	0 (no pain) and 100 (worst possible pain)	1 st hour after extubation
Primary	visual analogue score	0 (no pain) and 100 (worst possible pain)	2 nd hour after extubation
Primary	visual analogue score	0 (no pain) and 100 (worst possible pain)	4 th hour after extubation
Primary	visual analogue score	0 (no pain) and 100 (worst possible pain)	8 th hour after extubation
Primary	visual analogue score	0 (no pain) and 100 (worst possible pain)	12 th hour after extubation
Primary	visual analogue score	0 (no pain) and 100 (worst possible pain)	18 th hour after extubation
Primary	visual analogue score	0 (no pain) and 100 (worst possible pain)	24 th hour after extubation
Secondary	Total intraoperative opioid consumption		during the operation
Secondary	Total postoperative opioid consumption		24 hour after operation
Secondary	Number of patients need postoperative rescue tramadol		24 hours after extubation
Secondary	Time to patient extubation		at the end of surgery
Secondary	time for ICU discharge		72 hours after surgery
Secondary	postoperative complication		72 hours after surgery