Erector Spinae Plane Block and Pain Management in Cardiac Surgery (ESPCATHEART)

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)

Study Overview

• Status: Completed
• Conditions: Cardiac Surgery; Adult
• Intervention / Treatment: Drug: Ropivacaine

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.

• Study Type: Interventional
• Enrollment (Actual): 40
• Phase: Not Applicable

Contacts and Locations

Study Locations

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

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 18 years to 65 years (ADULT, OLDER_ADULT)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: All

Description

Inclusion Criteria:

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

Exclusion Criteria:

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

Study Plan

How is the study designed?

Design Details

• Primary Purpose: SUPPORTIVE_CARE
• Allocation: NA
• Interventional Model: SINGLE_GROUP
• Masking: NONE

Number of Arms

1

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
OTHER: peri operative analgesia; Post operative regional analgesia by Erector Spinae bilateral catheters with infusion of ropivacaine	Drug: Ropivacaine; ESP catheter; Other Names: ESP catheter

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Post operative Opioids consumption	Total dose of morphine used in post operative in mg of Morphine	48h.

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Acute post op pain	VAS Visual analogically scale from 0 to 10 at rest and Thorax mobilisation	1 hour after extubation
Pain at one month after surgery	VAS Visual analogically scale from 0 to 10 at rest and mobilisation	One month exactly = 30 days after date of surgery
Peri operative sufentanil consumption	Total dose of sufentanil in msg/kg	from induction anesthesia to last point of the skin (end of surgery) Time unit Hour

Collaborators and Investigators

• Sponsor: Vinmec Healthcare System
• Investigators: Study Chair: huyen vu, VinMEC

Study record dates

Study Major Dates

• Study Start (ACTUAL): October 20, 2017
• Primary Completion (ACTUAL): February 25, 2018
• Study Completion (ACTUAL): March 1, 2018

Study Registration Dates

• First Submitted: March 12, 2018
• First Submitted That Met QC Criteria: May 30, 2018
• First Posted (ACTUAL): May 31, 2018

Study Record Updates

• Last Update Posted (ACTUAL): May 31, 2018
• Last Update Submitted That Met QC Criteria: May 30, 2018
• Last Verified: May 1, 2018

More Information

Terms related to this study

• Keywords: Open heart surgery; Bilateral ESP Catheter; opioid free post op analgesia
• Additional Relevant MeSH Terms: Physiological Effects of Drugs; Central Nervous System Depressants; Peripheral Nervous System Agents; Sensory System Agents; Anesthetics; Anesthetics, Local; Ropivacaine
• Other Study ID Numbers: VINMEC HS

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: YES
• IPD Plan Description: excel sheet
• IPD Sharing Time Frame: April for 2 months
• IPD Sharing Access Criteria: Director of research
• IPD Sharing Supporting Information Type: STUDY_PROTOCOL; ICF; CSR

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No