Efficacy of Erector Spinae Plane Block Analgesia After Off Pump Cardiac Surgery (ESPB)

March 17, 2024 updated by: Amal Gouda Elsayed Safan, Menoufia University

Efficacy of Erector Spinae Plane Block on Postoperative Analgesia and Recovery After Off Pump Cardiac Surgery: A Randomised Trial

In this study the investigators will investigate the efficacy of ESPB as a part of Enhanced recovery after surgery on postoperative analgesia and recovery criteria after off pump cardiac surgery.

Study Overview




Detailed Description

General anaesthesia will be induced by 0.05 mg/kg midazolam, 3 µg/kg fentanyl, 1-2mg/kg propofol, and 0.5mg/kg of Atracurium. After induction, bilateral erector spinae plane block will be performed in the block group. Intraoperative analgesia will be achieved by fentanyl boluses of 0.5-to-1 µg/kg titrated according to haemodynamic parameters. Postoperative analgesia will be managed by paracetamol 1000 mg /6hours and morphine 1-2mg boluses when pain score ≥4 1 to 2 mg to be repeated every 5 minutes if needed.

Study Type


Enrollment (Actual)



  • Not Applicable

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Contact

Study Contact Backup

Study Locations

    • Shibin Elkom
      • Cairo, Shibin Elkom, Egypt
        • Menoufia University

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

18 years to 70 years (Adult, Older Adult)

Accepts Healthy Volunteers



Inclusion Criteria:

  • age 18-70 years
  • ejection fraction of > 45%
  • undergoing elective off-pump cardiopulmonary bypass surgery

Exclusion Criteria:

  • vertebral anomalies
  • intra-aortic balloon pump in the preoperative period
  • acute myocardial infarction
  • local infection at the site of block
  • allergy to the local anesthetic used
  • morbid obesity, psychiatric disorders, neurologic deficits, alcohol and chronic opioid abuse, and patients with bleeding diathesis.

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Other
  • Allocation: Randomized
  • Interventional Model: Parallel Assignment
  • Masking: None (Open Label)

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
Active Comparator: Erector spinae block group
the patients will be administered bilateral Erector spinae block with 20 ml of 0.25 % bupivacaine
After induction, the patients will be administered bilateral Erector spinae block with 20 ml of 0.25 % bupivacaine
fentanyl boluses of 0.5-to-1 µg/kg titrated according to haemodynamic parameters.
Other: control group
no block will be done but only IV analgesia.
fentanyl boluses of 0.5-to-1 µg/kg titrated according to haemodynamic parameters.

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Total intraoperative and postoperative opioid consumption
Time Frame: 48 hours
Microgram and mg
48 hours

Secondary Outcome Measures

Outcome Measure
Measure Description
Time Frame
pain intensity at rest and movement
Time Frame: 48 hours
numerical rating score from zero to ten ( 0=no pain, 10 =severe pain )
48 hours
time to first rescue analgesia
Time Frame: 24hous
Duration of mechanical ventilation
Time Frame: 24 hours
24 hours
time to extubation
Time Frame: 24hours
time to ambulation
Time Frame: 24hours
time to oral intake
Time Frame: 48 hours
48 hours
time of chest drain removal
Time Frame: 5 days
5 days
time of intensive care unit stay
Time Frame: one week
one week
The heart rate
Time Frame: 48 hours
Beats per minutes
48 hours
mean arterial blood pressure
Time Frame: 48 hours
48 hours

Collaborators and Investigators

This is where you will find people and organizations involved with this study.


  • Principal Investigator: Abd-Elazeem A Elbakry, MD, Menoufia University
  • Principal Investigator: AMAL G SAFAN, MD, Menoufia University
  • Principal Investigator: Islam M ElDesoky, MD, Menoufia University

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

March 22, 2023

Primary Completion (Actual)

October 10, 2023

Study Completion (Actual)

December 25, 2023

Study Registration Dates

First Submitted

February 12, 2023

First Submitted That Met QC Criteria

March 13, 2023

First Posted (Actual)

March 15, 2023

Study Record Updates

Last Update Posted (Actual)

March 19, 2024

Last Update Submitted That Met QC Criteria

March 17, 2024

Last Verified

March 1, 2024

More Information

Terms related to this study

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?


Drug and device information, study documents

Studies a U.S. FDA-regulated drug product


Studies a U.S. FDA-regulated device product


This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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