NCT05763810

Brief Summary

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

Trial Health

55
Monitor

Trial Health Score

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

Trial has exceeded expected completion date
Enrollment
22

participants targeted

Target at below P25 for not_applicable

Timeline
Completed

Started Mar 2023

Typical duration for not_applicable

Geographic Reach
1 country

1 active site

Status
active not recruiting

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 28, 2023

Completed
10 days until next milestone

First Posted

Study publicly available on registry

March 10, 2023

Completed
5 days until next milestone

Study Start

First participant enrolled

March 15, 2023

Completed
2.7 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

December 1, 2025

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

December 1, 2025

Completed
Last Updated

May 6, 2025

Status Verified

May 1, 2025

Enrollment Period

2.7 years

First QC Date

February 28, 2023

Last Update Submit

May 5, 2025

Conditions

Analgesia

Outcome Measures

Primary Outcomes (1)

  • Total opioid consumption

    µg and mg

    Perioperative.

Secondary Outcomes (6)

  • Pain intensity at rest and exercise

    Perioperative.

  • Extubation time

    Perioperative

  • Duration of post anaesthesia care unit stay

    Perioperative

  • Postoperative nausea

    Perioperative

  • Postoperative vomiting

    Perioperative

  • +1 more secondary outcomes

Study Arms (2)

Erector Spinae Plane Block group

OTHER

Erector Spinae Plane Block

Other: Erector Spinae Plane Block

Superficial Parasternal Intercostal Plane Block and Rectus Sheath Block group

OTHER

Superficial Parasternal Intercostal Plane Block and Rectus Sheath Block

Other: Superficial Parasternal Intercostal Plane Block combined with Rectus Sheath Block

Interventions

Erector Spinae Plane BlockOTHER

Erector Spinae Plane Block

Erector Spinae Plane Block group
Superficial Parasternal Intercostal Plane Block combined with Rectus Sheath BlockOTHER

Superficial Parasternal Intercostal Plane Block combined with Rectus Sheath Block

Superficial Parasternal Intercostal Plane Block and Rectus Sheath Block group

Eligibility Criteria

Age18 Years - 80 Years
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

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

You may not qualify if:

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

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Faculty of Medicine

Cairo, Shebin Elkom, Egypt

Location

MeSH Terms

Conditions

Agnosia

Condition Hierarchy (Ancestors)

Perceptual DisordersNeurobehavioral ManifestationsNeurologic ManifestationsNervous System DiseasesSigns and SymptomsPathological Conditions, Signs and Symptoms

Study Officials

  • Abd-Elazeem A Elbakry, MD

    Menoufia University

    PRINCIPAL INVESTIGATOR

  • Amal G Safan, MD

    Menoufia University

    PRINCIPAL INVESTIGATOR

  • Islam M El-Desoky, MD

    Menoufia University

    PRINCIPAL INVESTIGATOR

Study Design

Study Type
interventional
Phase
not applicable
Allocation
RANDOMIZED
Masking
NONE
Purpose
TREATMENT
Intervention Model
PARALLEL
Sponsor Type
OTHER
Responsible Party
SPONSOR INVESTIGATOR
PI Title
Professor

Study Record Dates

First Submitted

February 28, 2023

First Posted

March 10, 2023

Study Start

March 15, 2023

Primary Completion

December 1, 2025

Study Completion

December 1, 2025

Last Updated

May 6, 2025

Record last verified: 2025-05

Locations

EG(1)