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

NCT ID: NCT05769309

Last Updated: 2024-03-19

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

COMPLETED

Clinical Phase

NA

Total Enrollment

50 participants

Study Classification

INTERVENTIONAL

Study Start Date

2023-03-22

Study Completion Date

2023-12-25

Brief Summary

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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

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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.

Conditions

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Postoperative Pain

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

Primary Study Purpose

OTHER

Blinding Strategy

NONE

Study Groups

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Erector spinae block group

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

Group Type ACTIVE_COMPARATOR

Erector spinae block

Intervention Type PROCEDURE

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

Fentanyl

Intervention Type DRUG

fentanyl boluses of 0.5-to-1 µg/kg titrated according to haemodynamic parameters.

control group

no block will be done but only IV analgesia.

Group Type OTHER

Fentanyl

Intervention Type DRUG

fentanyl boluses of 0.5-to-1 µg/kg titrated according to haemodynamic parameters.

Interventions

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Erector spinae block

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

Intervention Type PROCEDURE

Fentanyl

fentanyl boluses of 0.5-to-1 µg/kg titrated according to haemodynamic parameters.

Intervention Type DRUG

Eligibility Criteria

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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.
Minimum Eligible Age

18 Years

Maximum Eligible Age

70 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No

Sponsors

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Menoufia University

OTHER

Sponsor Role lead

Responsible Party

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Amal Gouda Elsayed Safan

lecturer of anaethesia

Responsibility Role PRINCIPAL_INVESTIGATOR

Principal Investigators

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Islam M ElDesoky, MD

Role: PRINCIPAL_INVESTIGATOR

Menoufia University

AMAL G SAFAN, MD

Role: PRINCIPAL_INVESTIGATOR

Menoufia University

Abd-Elazeem A Elbakry, MD

Role: PRINCIPAL_INVESTIGATOR

Menoufia University

Locations

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Menoufia university

Cairo, Shibin Elkom, Egypt

Site Status

Countries

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Egypt

Other Identifiers

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2/2023 ANET10-2

Identifier Type: -

Identifier Source: org_study_id

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