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

Primary Purpose

Postoperative Pain

Status
Recruiting
Phase
Not Applicable
Locations
Egypt
Study Type
Interventional
Intervention
Erector spinae block
Fentanyl
Sponsored by
Menoufia University
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional other trial for Postoperative Pain

Eligibility Criteria

18 Years - 70 Years (Adult, Older Adult)All SexesDoes not accept 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.

Sites / Locations

  • Menoufia universityRecruiting

Arms of the Study

Arm 1

Arm 2

Arm Type

Active Comparator

Other

Arm Label

Erector spinae block group

control group

Arm Description

the patients will be administered bilateral Erector spinae block with 20 ml of 0.25 % bupivacaine

no block will be done but only IV analgesia.

Outcomes

Primary Outcome Measures

Total intraoperative and postoperative opioid consumption
Microgram and mg

Secondary Outcome Measures

pain intensity at rest and movement
numerical rating score from zero to ten ( 0=no pain, 10 =severe pain )
time to first rescue analgesia
minutes
Duration of mechanical ventilation
hours
time to extubation
min
time to ambulation
hours
time to oral intake
hours
time of chest drain removal
hours
time of intensive care unit stay
hours
The heart rate
Beats per minutes
mean arterial blood pressure
mmHg

Full Information

First Posted
February 12, 2023
Last Updated
September 27, 2023
Sponsor
Menoufia University
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1. Study Identification

Unique Protocol Identification Number
NCT05769309
Brief Title
Efficacy of Erector Spinae Plane Block Analgesia After Off Pump Cardiac Surgery
Acronym
ESPB
Official Title
Efficacy of Erector Spinae Plane Block on Postoperative Analgesia and Recovery After Off Pump Cardiac Surgery: A Randomised Trial
Study Type
Interventional

2. Study Status

Record Verification Date
September 2023
Overall Recruitment Status
Recruiting
Study Start Date
March 22, 2023 (Actual)
Primary Completion Date
October 2023 (Anticipated)
Study Completion Date
November 2023 (Anticipated)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Principal Investigator
Name of the Sponsor
Menoufia University

4. Oversight

Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
No
Data Monitoring Committee
No

5. Study Description

Brief Summary
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.
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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Postoperative Pain

7. Study Design

Primary Purpose
Other
Study Phase
Not Applicable
Interventional Study Model
Parallel Assignment
Masking
None (Open Label)
Allocation
Randomized
Enrollment
50 (Anticipated)

8. Arms, Groups, and Interventions

Arm Title
Erector spinae block group
Arm Type
Active Comparator
Arm Description
the patients will be administered bilateral Erector spinae block with 20 ml of 0.25 % bupivacaine
Arm Title
control group
Arm Type
Other
Arm Description
no block will be done but only IV analgesia.
Intervention Type
Procedure
Intervention Name(s)
Erector spinae block
Intervention Description
After induction, the patients will be administered bilateral Erector spinae block with 20 ml of 0.25 % bupivacaine
Intervention Type
Drug
Intervention Name(s)
Fentanyl
Intervention Description
fentanyl boluses of 0.5-to-1 µg/kg titrated according to haemodynamic parameters.
Primary Outcome Measure Information:
Title
Total intraoperative and postoperative opioid consumption
Description
Microgram and mg
Time Frame
48 hours
Secondary Outcome Measure Information:
Title
pain intensity at rest and movement
Description
numerical rating score from zero to ten ( 0=no pain, 10 =severe pain )
Time Frame
48 hours
Title
time to first rescue analgesia
Description
minutes
Time Frame
24hous
Title
Duration of mechanical ventilation
Description
hours
Time Frame
24 hours
Title
time to extubation
Description
min
Time Frame
24hours
Title
time to ambulation
Description
hours
Time Frame
24hours
Title
time to oral intake
Description
hours
Time Frame
48 hours
Title
time of chest drain removal
Description
hours
Time Frame
5 days
Title
time of intensive care unit stay
Description
hours
Time Frame
one week
Title
The heart rate
Description
Beats per minutes
Time Frame
48 hours
Title
mean arterial blood pressure
Description
mmHg
Time Frame
48 hours

10. Eligibility

Sex
All
Minimum Age & Unit of Time
18 Years
Maximum Age & Unit of Time
70 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
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.
Central Contact Person:
First Name & Middle Initial & Last Name or Official Title & Degree
AMAL G SAFAN, MD
Phone
01027386221
Ext
02
Email
AMAL.GODA52@med.menofia.edu.eg
First Name & Middle Initial & Last Name or Official Title & Degree
Abd-Elazeem A Elbakry, MD
Phone
01021678889
Ext
02
Email
abdelazeem.abd@med.menofia.edu.eg
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Islam M ElDesoky, MD
Organizational Affiliation
Menoufia University
Official's Role
Principal Investigator
First Name & Middle Initial & Last Name & Degree
AMAL G SAFAN, MD
Organizational Affiliation
Menoufia University
Official's Role
Principal Investigator
First Name & Middle Initial & Last Name & Degree
Abd-Elazeem A Elbakry, MD
Organizational Affiliation
Menoufia University
Official's Role
Principal Investigator
Facility Information:
Facility Name
Menoufia university
City
Cairo
State/Province
Shibin Elkom
Country
Egypt
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
AMAL G SAFAN, MD
Phone
0102738621
Email
AMAL.GODA52@med.menofia.edu.eg
First Name & Middle Initial & Last Name & Degree
Abd-Elazeem A Elbakry, MD
Phone
01021678889
Email
abdelazeem.abd@med.menofia.edu.eg

12. IPD Sharing Statement

Plan to Share IPD
No

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

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