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
1 other identifier
interventional
120
0 countries
N/A
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
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at P25-P50 for phase_3
Started Feb 2023
Shorter than P25 for phase_3
Health score is calculated from publicly available data and should be used for screening purposes only.
Trial Relationships
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Study Timeline
Key milestones and dates
First Submitted
Initial submission to the registry
January 11, 2023
CompletedFirst Posted
Study publicly available on registry
January 20, 2023
CompletedStudy Start
First participant enrolled
February 1, 2023
CompletedPrimary Completion
Last participant's last visit for primary outcome
July 1, 2023
CompletedStudy Completion
Last participant's last visit for all outcomes
July 1, 2023
CompletedJanuary 25, 2023
November 1, 2022
5 months
January 11, 2023
January 21, 2023
Conditions
Outcome Measures
Primary Outcomes (1)
Postoperative fentanyl requirements for 24 hours
Visual analogue score will be measured every 2 hours
24 hours postoperatively
Secondary Outcomes (3)
Visual analogue score
24 hours postoperatively
Rescue analgesia
24 hours postoperatively
Side effects
24 hours postoperatively
Study Arms (2)
Block group
ACTIVE COMPARATORPatients will be subjected to bilateral external oblique intercostal plane and pectointercostal plane blocks
Opioid group
ACTIVE COMPARATORPatients will be subjected to fentanyl infusion at a rate of 1μg/kg/h
Interventions
Patients will be subjected to bilateral external oblique intercostal plane and pectointercostal plane blocks
Patients will be subjected to fentanyl infusion at a rate of 1μg/kg/h
Eligibility Criteria
You may qualify if:
- patients undergoing CABG surgery
You may not qualify if:
- BMI above 40
- allergy for drugs used
- complicated cases
- patient refusal
- chronic opioid use
- cognitive dysfunction
- chronic kidney disease
Contact the study team to confirm eligibility.
Sponsors & Collaborators
Related Publications (1)
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.
PMID: 31054241BACKGROUND
Central Study Contacts
Study Design
- Study Type
- interventional
- Phase
- phase 3
- Allocation
- RANDOMIZED
- Masking
- DOUBLE
- Who Masked
- PARTICIPANT, INVESTIGATOR
- Masking Details
- Double blinded
- Purpose
- TREATMENT
- Intervention Model
- PARALLEL
- Sponsor Type
- OTHER
- Responsible Party
- SPONSOR
Study Record Dates
First Submitted
January 11, 2023
First Posted
January 20, 2023
Study Start
February 1, 2023
Primary Completion
July 1, 2023
Study Completion
July 1, 2023
Last Updated
January 25, 2023
Record last verified: 2022-11
Data Sharing
- IPD Sharing
- Will share
- Shared Documents
- STUDY PROTOCOL, CSR
- Time Frame
- One year
Data will be shared on request