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CompletedNCT03541837ESPCATHEARTUpdated May 31, 2018

Erector Spinae Plane Block and Pain Management in Cardiac Surgery

An interventional study of Ropivacaine in Cardiac Surgery and Adult, sponsored by Vinmec Healthcare System. Completed at 1 site in Vietnam. Open to participants aged 18 Years to 65 Years. Per ClinicalTrials.gov, last updated 2018-05-31.

Sponsored by Vinmec Healthcare System · Not applicable, Interventional, and Supportive care

From the registry’s dates

  • Registered 4 months after the study started (first participant enrolled Oct 2017, registered Mar 2018).
Phase
Not applicable
Study type
Interventional
Enrollment
40
Allocation
Not applicable
Ages
18 Years to 65 Years
Sex
All
01

Study 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)

Read the detailed description

After Patient's information and consent from the Ethical committee of VinMec Healthcare (#06/2017/HDD-VMEC) the anesthesia team will perform to all adult patients for open heart surgery after the anesthesia induction a bilateral insertion of an Erector Spinae Plane Block catheter under ultrasound guidance The Block performance :

Patient in right lateral decubitus. The anesthesiologist will use an high-frequency linear ultrasound transducer sagitally at T4 level to identify the lateral extremity of the T4 transverse process (Logic E GE USE). After inserting in plane a Tuohy needle 80 mm 18G the anesthesiologist will locate the tip of the needle and confirm by hydrodissection the inter-fascial space between the inter-transverse ligament anteriorly and the fascia of the Erector Spinae Muscle posteriorly . He will insert under ultrasound vision a catheter (Perifix B.Braun Germany) . The anesthesiologist check the right position of the catheter with a dextrose 5% injection = 2mL under ultrasound vision and see the spread of the Dextrose between in the inter-fascial space. This procedure will be bilateral. The catheter will have a yellow label on the Huer®-Lock connector to identify clearly that it is regional analgesia catheter to prevent any errors in these patients will a lot of catheters.

After this control an induction dose of Ropivacaine (0.5%) 0.25mL/Kg is injected in each catheter ( Loading dose).

8 h after a automatic infusion of Ropivacaine (0.2%) will be infused throw the 2 ESP catheters the infusion regimen will be Intermittent automatic bolus every 6h. on each catheter. The bolus on the second catheter will be delayed by 1 hour to minor the maximal plasmatic concentration.

Volume of the bolus:

For 40 to 50 kg patient the volume of intermittent automatic bolus will be 6 mL/ 6H/ Side For 50 to 60 kg patient the volume of intermittent automatic bolus will be 8 mL / 6H/ Side For 60 to 70 kg patient the volume of intermittent automatic bolus will be 10 mL / 6H/ Side For a 70 kg and > 1.70 m Patient the volume of intermittent automatic bolus will be 12 mL / 6H/ Side

If the block extension is not enough additional bolus by clinician only of 8 mL maximum 3 per day and 1 hour after the last automatic bolus delivered

If the analgesia is not efficient after 1 additional bolus the catheters will be removed and we will prescribe the classical IV analgesia as before.

The regional analgesia will be up to 4 hours after mediastinal drain removal and a maximum of 76h. after catheter incision

A Bi Daily inspection of the catheters insertion points will be done. If redness around puncture point the catheters will be removed and shift to classical IV analgesia to prevent any infection.

The criteria studied will be:

Consumption of opioids at 48h Variation of Blood pressure during sternotomy Level of pain at rest and mob after the surgery Time to extubate the patient Early mobilisation after surgery the quality of thorax expansion Level of pain 1 month after the surgery and limited activity at one month

The control group was an historical group of twenty consecutive patients, operated by the same surgeons from June 8th 2017 and August 1th 2017 and matched with the studied group, in which data were noted just before the introduction of ESB in the ERAS program. All data from the control group come from the centralized computer network of patient records at Vinmec University Hospital.

02

Conditions studied

  • Cardiac Surgery
  • Adult

Keywords

  • Bilateral ESP Catheter
  • Open heart surgery
  • opioid free post op analgesia
03

In context

Lead sponsor

Vinmec Healthcare System is the lead sponsor of 16 studies on the registry; 4 are open to participants now.

Counted across the registry records on this site, refreshed daily.

04

Who can participate

Ages eligible
18 Years to 65 Years
Sexes eligible
All
Accepts healthy volunteers
No

Inclusion criteria

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

Exclusion criteria

Exclusion Criteria:

  • refusal by patient
  • Unstable hemodynamic after induction
  • Failure of ESP catheter insertion Must have 2 ESP catheter well inserted
05

Study design

Phase
Not applicable
Primary purpose
Supportive care
Allocation
Not applicable
Intervention model
Single group
Masking
None (open label)
Enrollment
40 participants (actual)

Study arms

  • Other
    peri operative analgesia

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

    Drug: Ropivacaine

Interventions

  • DrugRopivacaine

    ESP catheter

    Also known as: ESP catheter

06

What researchers measure

Primary outcomes

  1. Post operative Opioids consumption

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

    Time frame: 48h.

Secondary outcomes

  1. Acute post op pain

    VAS Visual analogically scale from 0 to 10 at rest and Thorax mobilisation

    Time frame: 1 hour after extubation

  2. Pain at one month after surgery

    VAS Visual analogically scale from 0 to 10 at rest and mobilisation

    Time frame: One month exactly = 30 days after date of surgery

  3. Peri operative sufentanil consumption

    Total dose of sufentanil in msg/kg

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

07

Study locations

1 site
  • VinMec Central park International hospital
    Ho Chi Minh City, Vietnam
08

References and documents

Individual participant data

Plan to share: Yes — excel sheet

Supporting information: Study protocol, Icf, Csr

No publications or documents are linked to this record.

09

Updates

Tracking since Sep 25, 2026
No changes since tracking began. The registry record was last updated on May 31, 2018, before this site started recording changes on Sep 25, 2026. Its history is on ClinicalTrials.gov ↗
10

Registry details

Key details

Study ID
NCT03541837
Lead sponsor
Vinmec Healthcare System
Responsible party
Sponsor
First posted
May 31, 2018
Start date
Oct 20, 2017
Primary completion
Feb 25, 2018
Completion
Mar 1, 2018
Last update
May 31, 2018

Study contacts

huyen vu
study chair · VINMEC

Oversight

Data monitoring committee
Yes
FDA-regulated drug
No
FDA-regulated device
No
View the source record on ClinicalTrials.gov ↗

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