NCT03825068

Brief Summary

Studying the effect of erector spinae plane block in patients undergoing minimal invasive cardiac surgery.

Trial Health

43
At Risk

Trial Health Score

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

Trial has exceeded expected completion date
Enrollment
20

participants targeted

Target at below P25 for not_applicable

Timeline
Completed

Started Nov 2018

Typical duration for not_applicable

Geographic Reach
1 country

1 active site

Status
unknown

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

Study Start

First participant enrolled

November 15, 2018

Completed
3 months until next milestone

First Submitted

Initial submission to the registry

January 30, 2019

Completed
1 day until next milestone

First Posted

Study publicly available on registry

January 31, 2019

Completed
1.8 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

November 30, 2020

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

November 30, 2020

Completed
Last Updated

March 10, 2020

Status Verified

March 1, 2020

Enrollment Period

2 years

First QC Date

January 30, 2019

Last Update Submit

March 9, 2020

Conditions

Pain, Postoperative

Outcome Measures

Primary Outcomes (1)

  • VAS

    PAIN SCORES OF PATIENTS

    48 hours

Study Arms (2)

ESP block group

ACTIVE COMPARATOR

patients receive ESP Bock with local anaesthetics

Procedure: ESP Block

control group

PLACEBO COMPARATOR

general anaestesia

Drug: general anesthetic

Interventions

ESP BlockPROCEDURE

20 ml of lacal anaesthetics will be placed below the erector spinae muscle under ultrasound guide

ESP block group
general anestheticDRUG

patient receive general anaesthetic only

control group

Eligibility Criteria

Age20 Years - 50 Years
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64)

You may qualify if:

  • elective valve replacement

You may not qualify if:

  • chroic renal failure
  • chronic liver failure

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Assiut university

Asyut, 71111, Egypt

RECRUITING

MeSH Terms

Conditions

Pain, Postoperative

Interventions

Anesthetics, General

Condition Hierarchy (Ancestors)

Postoperative ComplicationsPathologic ProcessesPathological Conditions, Signs and SymptomsPainNeurologic ManifestationsSigns and Symptoms

Intervention Hierarchy (Ancestors)

AnestheticsCentral Nervous System DepressantsPhysiological Effects of DrugsPharmacologic ActionsChemical Actions and UsesCentral Nervous System AgentsTherapeutic Uses

Central Study Contacts

rasha hamed, lecturer

CONTACT

01000440773rashaahmed11@yahoo.com

Study Design

Study Type
interventional
Phase
not applicable
Allocation
RANDOMIZED
Masking
SINGLE
Who Masked
OUTCOMES ASSESSOR
Purpose
PREVENTION
Intervention Model
PARALLEL
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
lecturer of anaesthesia and pain management

Study Record Dates

First Submitted

January 30, 2019

First Posted

January 31, 2019

Study Start

November 15, 2018

Primary Completion

November 30, 2020

Study Completion

November 30, 2020

Last Updated

March 10, 2020

Record last verified: 2020-03

Locations

EG(1)