Regional Blocks for CABG Artery Bypass Graft Surgery

Ultrasound Guided External Oblique Intercostal Plane Block and Pectointercostal Plane Block for Perioperative Analgesia in Coronary Artery Bypass Graft Surgery: Prospective Randomized Controlled Study

Pain control after CABG is an essential step to guard against postoperative complications such as lung atelectasis. This major step can be achieved by opioids or regional blocks.

Regional blocks allow better pain control and avoid side effects of opioid based pain control

Study Overview

• Status: Not yet recruiting
• Conditions: Analgesia After Coronary Artery Bypass Graft Surgery
• Intervention / Treatment: Procedure: Pectointercostal plane block and external oblique intercostal plane block; Procedure: Fentanyl infusion

Detailed Description

Ultrasound guided External oblique intercostal plane block and pectointercostal plane block for perioperative analgesia in coronary artery bypass graft surgery: Prospective randomized controlled study

Introduction:

Pain control is a vital component to achieve enhanced recovery after cardiac surgery. Effective postoperative pain control will reduce the incidence of numerous postoperative complications, can facilitate early mobilization and may result in earlier recovery.

Pain control is historically achieved by the administration of opioids, which is associated with well-documented side effects, such as sedation, respiratory depression, pruritus, hallucinations and postoperative nausea and vomiting (PONV). Enhanced recovery following coronary artery bypass grafting (CABG) has gained attention even though there is limited evidence on the efficacy and effectiveness of existing analgesic techniques.

The external oblique intercostal plane and pectointercostal plane blocks are a new modality that will be used to improve pain-related outcomes after CABG surgery, and has not been extensively investigated. Therefore, we will test the hypothesis that external oblique intercostal plane and pectointercostal plane blocks can reduce cumulative opioid consumption for the patients undergoing CABG surgery when added to conventional multi-model intravenous analgesic technique.

The aim of this prospective comparative investigation is to assess the impact of external oblique intercostal plane and pectointercostal plane blocks in a multimodal perioperative analgesic regimen and any related side effects in patients undergoing CABG surgery.

Patients and Methods:

A prospective study will be carried out in Alexandria Main University Hospital on 120 American society of anaesthesiologists (ASA) II, III physical status aged 40-60 years scheduled for major upper abdominal surgery, after approval of the Medical Ethics Committee and an informed written consent. Patients will be categorized into two equal groups, group I (60) will be subjected to bilateral external oblique intercostal plane and pectointercostal plane blocks and group II (60) will be subjected to fentanyl infusion at a rate of 1μg/kg/h. During the patient stay in the ICU, total analgesic requirements will be measured in both groups. Also, sedation level, duration of intubation and length of ICU stay will be assessed.

• Study Type: Interventional
• Enrollment (Anticipated): 120
• Phase: Phase 3

Contacts and Locations

• Study Contact: Name: Mohamed Abdelmawla, MD; Phone Number: +201114748411; Email: M_abdelmawla12@alexmed.edu.eg
• Study Contact Backup: Name: Maha Ghanem, MD; Phone Number: +20127498435; Email: Ghanemmaha@yahoo.com

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: Child; Adult; Older Adult
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: All

Description

Inclusion Criteria:

• patients undergoing CABG surgery

Exclusion Criteria:

• BMI above 40
• allergy for drugs used
• complicated cases
• patient refusal
• chronic opioid use
• cognitive dysfunction
• chronic kidney disease

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Treatment
• Allocation: Randomized
• Interventional Model: Parallel Assignment
• Masking: Double

Number of Arms

2

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Active Comparator: Block group; Patients will be subjected to bilateral external oblique intercostal plane and pectointercostal plane blocks	Procedure: Pectointercostal plane block and external oblique intercostal plane block; Patients will be subjected to bilateral external oblique intercostal plane and pectointercostal plane blocks
Active Comparator: Opioid group; Patients will be subjected to fentanyl infusion at a rate of 1μg/kg/h	Procedure: Fentanyl infusion; Patients will be subjected to fentanyl infusion at a rate of 1μg/kg/h

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Postoperative fentanyl requirements for 24 hours	Visual analogue score will be measured every 2 hours	24 hours postoperatively

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Side effects	Any side effect related to fentanyl or block technique will be detected and treated properly	24 hours postoperatively
Visual analogue score	Visual analogue score will be measured every 2 hours	24 hours postoperatively
Rescue analgesia	0.5 microgram/kg fentanyl will be given if visual analogue score more than 4	24 hours postoperatively

Collaborators and Investigators

• Sponsor: Alexandria University

Publications and helpful links

General Publications

• Engelman DT, Ben Ali W, Williams JB, Perrault LP, Reddy VS, Arora RC, Roselli EE, Khoynezhad A, Gerdisch M, Levy JH, Lobdell K, Fletcher N, Kirsch M, Nelson G, Engelman RM, Gregory AJ, Boyle EM. Guidelines for Perioperative Care in Cardiac Surgery: Enhanced Recovery After Surgery Society Recommendations. JAMA Surg. 2019 Aug 1;154(8):755-766. doi: 10.1001/jamasurg.2019.1153.

Study record dates

Study Major Dates

• Study Start (Anticipated): February 1, 2023
• Primary Completion (Anticipated): July 1, 2023
• Study Completion (Anticipated): July 1, 2023

Study Registration Dates

• First Submitted: January 11, 2023
• First Submitted That Met QC Criteria: January 11, 2023
• First Posted (Actual): January 20, 2023

Study Record Updates

• Last Update Posted (Estimate): January 24, 2023
• Last Update Submitted That Met QC Criteria: January 21, 2023
• Last Verified: November 1, 2022

More Information

Terms related to this study

• Additional Relevant MeSH Terms: Physiological Effects of Drugs; Central Nervous System Depressants; Peripheral Nervous System Agents; Analgesics; Sensory System Agents; Anesthetics, Intravenous; Anesthetics, General; Anesthetics; Analgesics, Opioid; Narcotics; Adjuvants, Anesthesia; Fentanyl
• Other Study ID Numbers: 0305397

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: Yes
• IPD Plan Description: Data will be shared on request
• IPD Sharing Time Frame: One year
• IPD Sharing Supporting Information Type: Study Protocol; Clinical Study Report (CSR)

Drug and device information, study documents

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