NCT03541837

Brief Summary

Evaluation of the benefit effects of Peri-Operative analgesia by Continuous Bilateral Erector Spinae Plane block(ESP) for Open Cardiac Surgery: A case series prospective study with a comparison a retrospective case series (Before and after)

Trial Health

87
On Track

Trial Health Score

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

Enrollment
40

participants targeted

Target at P25-P50 for not_applicable

Timeline
Completed

Started Oct 2017

Shorter than P25 for not_applicable

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

Study Start

First participant enrolled

October 20, 2017

Completed
4 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

February 25, 2018

Completed
4 days until next milestone

Study Completion

Last participant's last visit for all outcomes

March 1, 2018

Completed
11 days until next milestone

First Submitted

Initial submission to the registry

March 12, 2018

Completed
3 months until next milestone

First Posted

Study publicly available on registry

May 31, 2018

Completed
Last Updated

May 31, 2018

Status Verified

May 1, 2018

Enrollment Period

4 months

First QC Date

March 12, 2018

Last Update Submit

May 30, 2018

Conditions

Cardiac SurgeryAdult

Keywords

Bilateral ESP CatheterOpen heart surgeryopioid free post op analgesia

Outcome Measures

Primary Outcomes (1)

  • Post operative Opioids consumption

    Total dose of morphine used in post operative in mg of Morphine

    48h.

Secondary Outcomes (3)

  • Acute post op pain

    1 hour after extubation

  • Pain at one month after surgery

    One month exactly = 30 days after date of surgery

  • Peri operative sufentanil consumption

    from induction anesthesia to last point of the skin (end of surgery) Time unit Hour

Study Arms (1)

peri operative analgesia

OTHER

Post operative regional analgesia by Erector Spinae bilateral catheters with infusion of ropivacaine

Drug: Ropivacaine

Interventions

RopivacaineDRUG

ESP catheter

Also known as: ESP catheter
peri operative analgesia

Eligibility Criteria

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

You may qualify if:

  • Consent signed
  • Open heart surgery
  • Hemodynamic stable after anesthesia induction No variation more than 20% of blood pressure

You may not qualify if:

  • refusal by patient
  • Unstable hemodynamic after induction
  • Failure of ESP catheter insertion Must have 2 ESP catheter well inserted

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

VinMec Central park International hospital

Ho Chi Minh City, Vietnam

Location

MeSH Terms

Interventions

Ropivacaine

Intervention Hierarchy (Ancestors)

AnilidesAmidesOrganic ChemicalsAniline CompoundsAmines

Study Officials

  • huyen vu

    VINMEC

    STUDY CHAIR

Study Design

Study Type
interventional
Phase
not applicable
Allocation
NA
Masking
NONE
Purpose
SUPPORTIVE CARE
Intervention Model
SINGLE GROUP
Model Details: Prospective series case compared to a before group of consecutive patients
Sponsor Type
OTHER
Responsible Party
SPONSOR

Study Record Dates

First Submitted

March 12, 2018

First Posted

May 31, 2018

Study Start

October 20, 2017

Primary Completion

February 25, 2018

Study Completion

March 1, 2018

Last Updated

May 31, 2018

Record last verified: 2018-05

Data Sharing

IPD Sharing
Will share

excel sheet

Shared Documents
STUDY PROTOCOL, ICF, CSR
Time Frame
April for 2 months
Access Criteria
Director of research

Locations

VN(1)