We're building a better ClinicalTrials.gov. Check it out and tell us what you think!
Working…
ClinicalTrials.gov
ClinicalTrials.gov Menu

Regional Blocks for CABG Artery Bypass Graft Surgery

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Know the risks and potential benefits of clinical studies and talk to your health care provider before participating. Read our disclaimer for details.
 
ClinicalTrials.gov Identifier: NCT05691920
Recruitment Status : Not yet recruiting
First Posted : January 20, 2023
Last Update Posted : January 25, 2023
Sponsor:
Information provided by (Responsible Party):
Alexandria University

Study Description
Go to 
Top of Page Study Description Study Design Arms and Interventions Outcome Measures Eligibility Criteria Contacts and Locations More Information
Brief Summary:

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


Condition or disease Intervention/treatment Phase
Analgesia After Coronary Artery Bypass Graft Surgery Procedure: Pectointercostal plane block and external oblique intercostal plane block Procedure: Fentanyl infusion Phase 3

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 Design
Go to 
Top of Page Study Description Study Design Arms and Interventions Outcome Measures Eligibility Criteria Contacts and Locations More Information

Layout table for study information
Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 120 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Double (Participant, Investigator)
Masking Description: Double blinded
Primary Purpose: Treatment
Official Title: Ultrasound Guided External Oblique Intercostal Plane Block and Pectointercostal Plane Block for Perioperative Analgesia in Coronary Artery Bypass Graft Surgery: Prospective Randomized Controlled Study
Estimated Study Start Date : February 1, 2023
Estimated Primary Completion Date : July 1, 2023
Estimated Study Completion Date : July 1, 2023

Resource links provided by the National Library of Medicine


Arms and Interventions
Go to 
Top of Page Study Description Study Design Arms and Interventions Outcome Measures Eligibility Criteria Contacts and Locations More Information

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


Outcome Measures
Go to 
Top of Page Study Description Study Design Arms and Interventions Outcome Measures Eligibility Criteria Contacts and Locations More Information

Primary Outcome Measures :
  1. Postoperative fentanyl requirements for 24 hours [ Time Frame: 24 hours postoperatively ]
    Visual analogue score will be measured every 2 hours


Secondary Outcome Measures :
  1. Visual analogue score [ Time Frame: 24 hours postoperatively ]
    Visual analogue score will be measured every 2 hours

  2. Rescue analgesia [ Time Frame: 24 hours postoperatively ]
    0.5 microgram/kg fentanyl will be given if visual analogue score more than 4

  3. Side effects [ Time Frame: 24 hours postoperatively ]
    Any side effect related to fentanyl or block technique will be detected and treated properly


Eligibility Criteria
Go to 
Top of Page Study Description Study Design Arms and Interventions Outcome Measures Eligibility Criteria Contacts and Locations More Information

Information from the National Library of Medicine

Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the contacts provided below. For general information, Learn About Clinical Studies.


Layout table for eligibility information
Ages Eligible for Study:   Child, Adult, Older Adult
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Criteria

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
Contacts and Locations
Go to 
Top of Page Study Description Study Design Arms and Interventions Outcome Measures Eligibility Criteria Contacts and Locations More Information

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT05691920


Contacts
Layout table for location contacts
Contact: Mohamed Abdelmawla, MD +201114748411 M_abdelmawla12@alexmed.edu.eg
Contact: Maha Ghanem, MD +20127498435 Ghanemmaha@yahoo.com

Sponsors and Collaborators
Alexandria University
More Information
Go to 
Top of Page Study Description Study Design Arms and Interventions Outcome Measures Eligibility Criteria Contacts and Locations More Information
Publications:

Layout table for additonal information
Responsible Party: Alexandria University
ClinicalTrials.gov Identifier: NCT05691920    
Other Study ID Numbers: 0305397
First Posted: January 20, 2023    Key Record Dates
Last Update Posted: January 25, 2023
Last Verified: November 2022
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: Yes
Plan Description: Data will be shared on request
Supporting Materials: Study Protocol
Clinical Study Report (CSR)
Time Frame: One year
URL: http://www.alexu.edu.eg

Layout table for additional information
Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: No
Additional relevant MeSH terms:
Layout table for MeSH terms
Fentanyl
Analgesics, Opioid
Narcotics
Central Nervous System Depressants
Physiological Effects of Drugs
Analgesics
 Sensory System Agents
Peripheral Nervous System Agents
Adjuvants, Anesthesia
Anesthetics, Intravenous
Anesthetics, General
Anesthetics