NCT05769309

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.

Trial Health

87
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
50

participants targeted

Target at below P25 for not_applicable postoperative-pain

Timeline
Completed

Started Mar 2023

Geographic Reach
1 country

1 active site

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

First Submitted

Initial submission to the registry

February 12, 2023

Completed
1 month until next milestone

First Posted

Study publicly available on registry

March 15, 2023

Completed
7 days until next milestone

Study Start

First participant enrolled

March 22, 2023

Completed
7 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

October 10, 2023

Completed
3 months until next milestone

Study Completion

Last participant's last visit for all outcomes

December 25, 2023

Completed
Last Updated

March 19, 2024

Status Verified

March 1, 2024

Enrollment Period

7 months

First QC Date

February 12, 2023

Last Update Submit

March 17, 2024

Conditions

Postoperative Pain

Outcome Measures

Primary Outcomes (1)

  • Total intraoperative and postoperative opioid consumption

    Microgram and mg

    48 hours

Secondary Outcomes (10)

  • pain intensity at rest and movement

    48 hours

  • time to first rescue analgesia

    24hous

  • Duration of mechanical ventilation

    24 hours

  • time to extubation

    24hours

  • time to ambulation

    24hours

  • +5 more secondary outcomes

Study Arms (2)

Erector spinae block group

ACTIVE COMPARATOR

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

Procedure: Erector spinae blockDrug: Fentanyl

control group

OTHER

no block will be done but only IV analgesia.

Drug: Fentanyl

Interventions

Erector spinae blockPROCEDURE

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

Erector spinae block group
FentanylDRUG

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

Erector spinae block groupcontrol group

Eligibility Criteria

Age18 Years - 70 Years
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

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

You may not qualify if:

  • 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.

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Menoufia university

Cairo, Shibin Elkom, Egypt

Location

MeSH Terms

Conditions

Pain, Postoperative

Interventions

Fentanyl

Condition Hierarchy (Ancestors)

Postoperative ComplicationsPathologic ProcessesPathological Conditions, Signs and SymptomsPainNeurologic ManifestationsSigns and Symptoms

Intervention Hierarchy (Ancestors)

PiperidinesHeterocyclic Compounds, 1-RingHeterocyclic Compounds

Study Officials

  • Islam M ElDesoky, MD

    Menoufia University

    PRINCIPAL INVESTIGATOR

  • AMAL G SAFAN, MD

    Menoufia University

    PRINCIPAL INVESTIGATOR

  • Abd-Elazeem A Elbakry, MD

    Menoufia University

    PRINCIPAL INVESTIGATOR

Study Design

Study Type
interventional
Phase
not applicable
Allocation
RANDOMIZED
Masking
NONE
Purpose
OTHER
Intervention Model
PARALLEL
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
lecturer of anaethesia

Study Record Dates

First Submitted

February 12, 2023

First Posted

March 15, 2023

Study Start

March 22, 2023

Primary Completion

October 10, 2023

Study Completion

December 25, 2023

Last Updated

March 19, 2024

Record last verified: 2024-03

Data Sharing

IPD Sharing
Will not share

Locations

EG(1)