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Cardiac SurgeryESPCATHEARTNCT03541837

Erector Spinae Plane Block and Pain Management in Cardiac Surgery

A study testing Ropivacaine in people with Cardiac Surgery and Adult, run by Vinmec Healthcare System at 1 site in Vietnam.

Completed

Finished. The study has ended and is not enrolling. Results may be posted on the official record.

Official record
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Trial 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 more about this study

Who is it for?
Ages 18 to 65 years
Conditions the study is for
Cardiac Surgery, Adult
What is being tested?
Ropivacaine
Type of treatment
Injection or infusion
Could I receive a placebo?
No, everyone receives an active treatment
How many people
40 participants
Where
1 siteVietnam
Study dates
20 Oct 2017to 1 Mar 2018
Phase
Interventional
Are there results?
None posted in the registry

Key requirements

Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.

  • Ages 18 to 65 years
  • All sexes
  • No healthy volunteers
  • Adult, Older adult

Who may be able to join

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

Who cannot join

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

Trial locations and contacts

1 site in 1 country.

Vietnam1 site
  • VinMec Central park International hospital

    Ho Chi Minh City

Other trials in Vietnam

About this study

Official title: Ultrasound Guided Thoracic Erector Spinae Plane Blocks Within an Enhanced Recovery Program Decreases Opioids Consumption and Improves Patient Postoperative Rehabilitation After Open Cardiac Surgery: A Controlled Before-After Study

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.

Being tested
Ropivacaine
Keywords
Bilateral ESP Catheter, Open heart surgery, opioid free post op analgesia

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

Study groups in NCT03541837
Study groupRoleWhat they receive
peri operative analgesiaOtherPost operative regional analgesia by Erector Spinae bilateral catheters with infusion of ropivacaine
Receives: Drug: Ropivacaine

What is being measured

The primary outcome is the main question the study is designed to answer.

  1. Post operative Opioids consumption

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

    Measured: 48h.

Secondary outcomes (3)
  1. Acute post op pain

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

    Measured: 1 hour after extubation

  2. Pain at one month after surgery

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

    Measured: One month exactly = 30 days after date of surgery

  3. Peri operative sufentanil consumption

    Total dose of sufentanil in msg/kg

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

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

  1. First posted31 May 2018
  2. Study start20 Oct 2017
  3. Primary completion25 Feb 2018
  4. Study completion1 Mar 2018

Resources

More details

For doctors and researchers: how the study is designed, who runs it, and its registry IDs.

Study design
Study type
Interventional
Phase
Phase N/A
Primary purpose
Supportive care
Allocation
Not applicable
Intervention model
Single group
Model description
Prospective series case compared to a before group of consecutive patients
Masking
None (open label)
Enrolment
40 participants (actual)
IDs, dates and publications
ClinicalTrials.gov ID
NCT03541837
Sponsor's protocol ID
VINMEC HS
Acronym
ESPCATHEART
Status last verified
May 2018
First submitted
12 Mar 2018
Last updated
31 May 2018
Results posted
No
Data monitoring committee
Yes
FDA-regulated drug
No
FDA-regulated device
No
Individual data sharing
Yes: excel sheet

Questions about this trial

What is this clinical trial studying?

A study testing Ropivacaine in people with Cardiac Surgery and Adult, run by Vinmec Healthcare System at 1 site in Vietnam.

The full registered description is in the About this study section and the official record.

Who may be eligible to take part?

The sponsor lists 3 inclusion and 3 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.

Is this clinical trial currently recruiting?

The record says: finished, as of the sponsor's last update on 31 May 2018. Status can change between updates, so confirm with the study contact before making plans.

Where is the study taking place?

The record lists 1 site in Vietnam. Whether a site is taking part right now should be confirmed with that site. See every site.

What are the possible benefits and risks?

They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.

Are results available for this study?

The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.

How can a doctor refer a patient or contact the research team?

The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.

What does the primary outcome measure?

Post operative Opioids consumption (time frame: 48h.). It is what the study was designed to measure, not a finding.

Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?

No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.

How often is this information updated?

AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 31 May 2018.

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