NCT03997019

Brief Summary

ultrasound guided bilateral erector spinae plane block will be used as adjuvant to general anaesthesia in 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
40

participants targeted

Target at P25-P50 for not_applicable

Timeline
Completed

Started Feb 2019

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

February 15, 2019

Completed
5 days until next milestone

First Submitted

Initial submission to the registry

February 20, 2019

Completed
4 months until next milestone

First Posted

Study publicly available on registry

June 25, 2019

Completed
1.4 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

November 15, 2020

Completed
1 month until next milestone

Study Completion

Last participant's last visit for all outcomes

December 15, 2020

Completed
Last Updated

June 25, 2019

Status Verified

June 1, 2019

Enrollment Period

1.8 years

First QC Date

February 20, 2019

Last Update Submit

June 22, 2019

Conditions

Pain, Acute

Outcome Measures

Primary Outcomes (1)

  • pain score

    NRS will be used to assess pain

    48 hours

Secondary Outcomes (3)

  • anaesthesia consumption

    6 hours

  • ultrasound guided postoperative diaphragmatic excursion

    24 hours

  • spirometric respiratory funtion

    24 hours

Study Arms (2)

group A

ACTIVE COMPARATOR

opioid analgesia

Procedure: opioid analgesia

group B

ACTIVE COMPARATOR

ESP block

Procedure: ESP block

Interventions

opioid analgesiaPROCEDURE

opioid analgesia will be used with general anaesthesia

group A
ESP blockPROCEDURE

ultrasound guided ESP Block before anaesthesia induction

group B

Eligibility Criteria

Age30 Years - 60 Years
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64)

You may qualify if:

  • elective surgery

You may not qualify if:

  • emergency
  • patient refusal
  • infection at or near catheter insertion

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Faculty of Medicine

Asyut, 71111, Egypt

RECRUITING

MeSH Terms

Conditions

Acute Pain

Condition Hierarchy (Ancestors)

PainNeurologic ManifestationsSigns and SymptomsPathological Conditions, Signs and Symptoms

Study Design

Study Type
interventional
Phase
not applicable
Allocation
RANDOMIZED
Masking
DOUBLE
Who Masked
PARTICIPANT, OUTCOMES ASSESSOR
Masking Details
both patient and data collector will be unaware of the group nature
Purpose
PREVENTION
Intervention Model
PARALLEL
Model Details: group A WILL RECEIVE OPOID analgesia group B will receive ESP block
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
lecturer of anaesthesia and pain management

Study Record Dates

First Submitted

February 20, 2019

First Posted

June 25, 2019

Study Start

February 15, 2019

Primary Completion

November 15, 2020

Study Completion

December 15, 2020

Last Updated

June 25, 2019

Record last verified: 2019-06

Data Sharing

IPD Sharing
Will not share

Locations

EG(1)