Comparing Different Regional Blocks for Analgesia After Off-pump Cardiac Surgery

January 25, 2024 updated by: Abd-Elazeem Abd-Elhameed Elbakry

Analgesic Effects of Erector Spinae Plane Block Versus Superficial Parasternal Intercostal Plane Block Combined With Rectus Sheath Block After Off Pump Cardiac Surgery: A Randomised Trial

This study aims to compare the analgesic effects of erector spinae plane block versus Superficial Parasternal Intercostal Plane Block block along with rectus sheath block after off-pump cardiac surgery

Study Overview

Status

Active, not recruiting

Conditions

Intervention / Treatment

Detailed Description

General anaesthesia will be used for all patients. induction by midazolam 0.05-0.1 mg/kg, fentanyl 2-5 µ/kg, propofol 1-2 mg/kg, and atracurium 0.5 mg/kg for intubation. Maintenance by sevoflurane in oxygen-air mixture. regional blocks will be used after the induction of anaesthesia. Intraoperative analgesia will be maintained by fentanyl infusion 1-2 µ/kg/h while morphine sulphate 2.5-5mg will be used as rescue analgesia when pain score>4 beside acetaminophen 1000 mg /6 hours

Study Type

Interventional

Enrollment (Actual)

22

Phase

  • 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 Locations

  • Egypt
    • Shebin Elkom
      • Cairo, Shebin Elkom, Egypt
        • Faculty of medicine

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 80 years (Adult, Older Adult)

Accepts Healthy Volunteers

No

Description

Inclusion Criteria:

  • American Society of anaesthesiologists physical status classification II-III
  • Elective off-pump cardiac surgery

Exclusion Criteria:

  • Cognitive impairment
  • Allergy to local anaesthetics
  • Renal and/or hepatic dysfunction
  • Ejection fraction< 45%

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: Treatment
  • Allocation: Randomized
  • Interventional Model: Parallel Assignment
  • Masking: None (Open Label)

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
Other: Erector Spinae Plane Block group
Erector Spinae Plane Block
Other: Erector Spinae Plane Block
Erector Spinae Plane Block
Other: Superficial Parasternal Intercostal Plane Block and Rectus Sheath Block group
Superficial Parasternal Intercostal Plane Block and Rectus Sheath Block
Other: Superficial Parasternal Intercostal Plane Block combined with Rectus Sheath Block
Superficial Parasternal Intercostal Plane Block combined with Rectus Sheath Block

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Total opioid consumption
Time Frame: Perioperative.
µg and mg
Perioperative.

Secondary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Pain intensity at rest and exercise
Time Frame: Perioperative.
Visual analogue score: a score from 0 to 10(0= no pain and 10 the worst imaginable pain)
Perioperative.
Extubation time
Time Frame: Perioperative
minutes
Perioperative
Duration of post anaesthesia care unit stay
Time Frame: Perioperative
minutes
Perioperative
Postoperative nausea
Time Frame: Perioperative
number (%)
Perioperative
Postoperative vomiting
Time Frame: Perioperative
number (%)
Perioperative
Duration of hospital stay
Time Frame: Postoperative up to 4 weeks
days
Postoperative up to 4 weeks

Collaborators and Investigators

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

Sponsor

Abd-Elazeem Abd-Elhameed Elbakry

Investigators

  • Principal Investigator: Abd-Elazeem A Elbakry, MD, Menoufia University
  • Principal Investigator: Islam M El-Desoky, MD, Menoufia University
  • Principal Investigator: AMAL G SAFAN, 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 15, 2023

Primary Completion (Estimated)

April 1, 2024

Study Completion (Estimated)

April 1, 2024

Study Registration Dates

First Submitted

February 28, 2023

First Submitted That Met QC Criteria

February 28, 2023

First Posted (Actual)

March 10, 2023

Study Record Updates

Last Update Posted (Actual)

January 26, 2024

Last Update Submitted That Met QC Criteria

January 25, 2024

Last Verified

January 1, 2024

More Information

Terms related to this study

Other Study ID Numbers

  • 2/2023 ANET 15-3

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

No

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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