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Open Heart SurgeryESP_ERCSNCT04506762

Benefit of Peri-operative Bilateral ESP Catheters for Enhanced Recovery for Cardiac Surgery (ERCS)

A study testing Regional analgesia in people with Open Heart Surgery, run by Vinmec Healthcare System at 1 site in Vietnam.

Terminated

Stopped early. The study ended before it was planned to and will not resume.

Official record
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Trial summary

To demonstrate if the addition of peri-operative regional analgesia by Bilateral ESP catheters improves the enhanced recovery program after open heart surgeries for the duration of hospitalisation, quality of analgesia, Consumption of peri-operative opioids, quality of recovery and quality of life. Read more about this study

Who is it for?
Ages 18 to 60 years
Conditions the study is for
Open Heart Surgery
What is being tested?
Regional analgesia
Type of treatment
Surgery or procedure
Could I receive a placebo?
No, everyone receives an active treatment
How many people
20 participants
Where
1 siteVietnam
Study dates
1 Nov 2020to 14 Aug 2023
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 60 years
  • All sexes
  • No healthy volunteers
  • Adult

Who may be able to join

  • Open heart surgeries: Valvulopathies ( 1-2 valves, repair or replacement)
  • Congenital heart disease (Risk Adjustment in Congenital Heart Surgery Category 1-2 ( VSD, ASD, T4F)
  • NYHA II,
  • Fraction ejection > 50%,
  • PAPS < 50 mmHg.
  • Male
Show all 9Show fewer
  • Female
  • Age from 18-60 years old.
  • Consent participation

Who cannot join

  • Refusal participation.
  • Allergy to LA
  • Severe thoracic Scoliosis
  • Valvulopathies association with :
  • CABG
  • BENTALL procedure
Show all 15Show fewer
  • Deficit mental
  • Alcoholics,
  • Heroine addicted
  • Insufficient renal
  • liver failure
  • Endocarditis <1 year
  • Stroke <3 months
  • MI <3 months
  • Bloc AV II or III with Pacemaker permanent

Trial locations and contacts

1 site in 1 country.

Vietnam1 site
  • VinMec INternational hopspital

    Hanoi

Other trials in Vietnam

About this study

Official title: Does Bilateral Continuous Peri Operative Erector Spinae Plane Block Improve The Enhanced Recovery Program After Open Heart Surgeries in Adults?

To demonstrate if the addition of peri-operative regional analgesia by Bilateral ESP catheters improves the enhanced recovery program after open heart surgeries for the duration of hospitalisation, quality of analgesia, Consumption of peri-operative opioids, quality of recovery and quality of life.

Patients will be randomly divided in 2 groups Group 1 With the actual standards of care for enhanced recovery after cardiac surgery including opioid sparing peri operative analgesia Group 2 With the actual standards of care for enhanced recovery after cardiac surgery replacing the opioid analgesia by a peri operative analgesia by bilateral ESP catheters

Read the detailed description
  1. CONSULTING PHASE: 1 WEEK BEFORE SURGERY
  2. Preoperative information, education and counselling: patient and families receive dedicated preoperative counselling including information packets.
  3. Preoperative optimization: medical optimization before surgery, including renal, pulmonary, and endocrine function.
  4. Smoking and alcohol cessation: smoking and alcohol cessation advised and promoted before surgery.
  5. Preoperative nutrition status: patients screened for nutritional status and counselling given for a protein-rich diet at least the week before the surgery.

II. PREOPERATIVE PHASE: 2 DAYS BEFORE SURGERY

  1. Preoperative fasting and carbohydrate treatment: patients are kept NPO 8h before surgery except for oral carbohydrate beverage given 2-4h before surgery.
  2. Reviewed all examination results: cardiac echography, X-ray, biology's tests
  3. Consents signed.
  4. Authorization operative be signed
  5. Preoperative multimodal analgesic initiated : before surgery 2 h Gabapentin: 600 mg (P.O) Acetaminophen: 500 mg (P.O) Hydroxyzine: 50 mg (P.O)

III. INTRAOPERATIVE PHASE:

  1. Monitoring: Usual Monitoring for Open heart surgery plus a pain monitor Ani •
  2. Anesthesia: Drugs Ketamine Ketamin: 0,10 mg/kg (bolus) then 0.10 mcg/kg/h Propofol TCI mode Target Entropy from 40-60 Sufentanil 1 mcg/kg (bolus for Intubation) then 0,1-1 mcg/kg/min (50 < ANI , 70) Esmeron 0.6 - 1 mg/kg (bolus pour intubation) (TOF = 0) then 0.3 mg/kg/h 0.6 - 1 mg/kg (bolus pour intubation) (TOF = 0) then 0.3 mg/kg/h Esomeprazole 40 mg (IV) Dexamethasone 0.1 mg/kg Magnesium 10 mg/kg then 10 mg/kg/h Antibio-prophylaxy Cefazolin 2g (IV) or vancomycin 15 mg/kg before incision 1 hours. erector spinae plane (ESP) block insertion cathter 30 - 40 kg = 6 mL / side 40 - 50 kg = 8 mL / side 50 - 60 kg = 10 mL / side 60 - 70 kg = 12 mL / side > 70 kg = 14 mL / side Tramexamic Acid 2 g ( IV) 2 g (IV) Heparin 3mg/kg (bolus in Central line), 25 mg in By Pass 3mg/kg (bolus in Central line), 25 mg in By Pass ESP catheter Performance (Kit epidural for adult Tuohy needle 19 G Catheter 20G) It is strictly forbidden to withdraw the inserted catheter throw the needle. If you need to retrieve the catheter you must retrieve the needle with the catheter. Patient in Right Lateral decubitus only if Hemodynamic stable US control of needle tip (dextrose 5%) Insertion of Catheter 20G under US visualization Tip to the top of the next transverse process Test the catheter with dextrose and see the spread of the liquid under US guidance in the interfascial space anterior to the ES muscle.
  • Induction 30 min before incision
  • Identify the 2 catheters by Yellow labels (Regional analgesia code)
  • No Variation of BP during sternotomy = ESP efficient If not Sufentanil Bolus Coagulation test before to start By Pass ACT > 400 secondes BEFORE start by pass . Inform Surgeon (Do NOT START If NOT)
  1. Cardiac by pass:
  • Cannulation Time Aortic Y cave Venous Sup and Inf or AtrioCave Connection to By Pass Air Lock Start By Pass = Volume 950-1000 ml (Ringer lactate, Gelofusine, Mannitol \&t Natri bicarbonate.); Aortic clamp; Cardioplegia Type Cold: crystalloid 4-8 degree celsius (CUSTODIOL); Anaesthesia Action: Stop Ventilation disconnect ETtube/ VA Circuit only when Bypass provide a full hemodynamic CO= 2.4.BSA l/m2.min. in and out (message FULL FLOW from perfusionist) Maintenance anesthesia depth by ENTROPY 40-60, ANI >40 Perfusionist targets MAP 50-80 mmHg , CO = 2, 4. BSA (L/m2.min.) SVO2 > 75% Blood tests /30 mn (ABG , lactate, Hb, Glycemie, ACT with heparin reinjection )
  1. Before Getting Out Of By Pass:
  • Anaesthesia Actions Ventilation
  • Restart Ventilation + Reconnect ETtube-> VA Circuit
  • Recruitment Manoeuvers low pressure Temperature and warming Cross clamp time Rhythm Monitoring Turn on the alarms De-Airing manoeuvres by surgeon \& by anesthesiologist with Control by TEE. Evaluation the result of surgeon and EF before decision to use inotropes or not.
  • Removal Aortic Clamp and spontaneous defibrillation
  • Perfusion and vaso active drugs assistance SVR - MAP- CVP -CI-SVRI-SVV
  • Inotropes - Vasoconstrictors - Volemia
  • Removal Veinous Canule
  1. After Bypass:
  • Test de pace-maker
  • Protamin: Slow IV protamine (dose protamine = dose heparin Total given)
  • Transamin : 2g (IV)
  • Ondansetron 4 mg (IV) - PONV prophylaxy
  • Blood tests 15 min after protamin: ABG Lactate, APTT, PT, FIBRINOGEN, Hb, Glycemia, NFS,
  • ACT to base line : 120-130 if not => More protamine
  • Blood transfusion if Hb < 10g/dL or Hct < 30%
  • Platelet transfusion if PLT< 80 000
  • Plasma fresh frozen transfusion if TP < 50%
  • Drains check.
  • Check coagulation total and blood gaz test
  • Ventilation recruitments manoeuvres

IV. POSTOPERATIVE PHASE:

  1. CICU transfer: According to guidelines intubated ventilated patient transfer.
  2. CICU:
  • Information according to guidelines Reception patient from OT
  • Identification of the 2 regional analgesia ESP catheters (Yellow Labels)
  • Drains check
  • Blood test on arrival ABG , Lactate, Hb, Glycemia, NFS, RP, ECG at arrival CICU
  • ABG, glycemie repeat every 4 hours
  • Sedation : Stable patient propofol 30-50 mg/h for 2 hours and stop when weaning criteria riched
  • Protocol for analgesia: all groups Paracetamol 1g/6h (infusion) Ketorolac 30 mg/8h Nefopam 100 mg/24h ESP Catheter with analgesia solution Micrel Pumps with intermittent automatic bolus (IAB) connected and started at T0 Pump preparation and settings: -Patient 30 - 40 kg = 6 mL / side/6h -Patient 40 - 50 kg = 8 mL / side/6h
  • Patient 50 - 60 kg = 10 mL/ side/6h
  • Patient 60 - 70 kg = 12 mL/ side/6h
  • Patient > 70 kg = 14 mL / side/6h The bolus on the second catheter will be delayed by 1 hour Intermittent programmed bolus every 6h Rescue analgesia Morphine 50 mcg/kg/min if FLACC >3 or ANI < 40
  • Fluid management: goal directed fluid therapy (GDFT) controlled by hemodynamics monitoring (Flotrac): CI, SVV, SVRI, CVP. Glucose 5%: 01 ml/kg/h + electrolyte balance. Bilan import, export/ 6hours • Early extubation: (criteria weaning and extubation appendix 1)
  • Early mobilization: After extubation 4 hours, sitting in bed and moving thoracic. Analgeia protocle after extubation If Continuous infusion of morphine replace by Morphine PCA • Concentration Morphine : 50 mg/49 ml + Ketamine 50 mg • Loading dose: 1mg
  • PCA dose demand: 1 mg/dose
  • Lockout: 10 min
  • Continuous rate (basal): 0
  • Dose limit (hr): 6mg/hour Plan with daily goals for time out of bed and distance walked beginning as soon as the day of surgery.
  • Early feeding: No sonde gastric Prevention PONV Drinking clear liquids after extubation 4 hours, eating after 6 hours.
  1. Criteria drain thoracic removal:
  • Liquid of mediastenal drains = 0 ml/ 2h;
  • No pleural effusion major;
  • No pneumothorax major;
  • ESP catheters removed 4h after drain removal;
  • After ESP catheter removed analgesia in both group only by:

Efferalgan : 15-20 mg/kg/6h (P.O) Ibuprofen : 400 mg/8h (P.O) Gabapentin : 300 mg/6h (P.O) (5 days postop) 5. Discharge from CICU( criteria discharge appendix 1):

  • VAS scores at rest and mob during hospitalization
  • VAS scores at rest and mob at 1 month with return to normal activities
  1. Pain Evaluation:
  • Patient Intubated scale FLACC , at rest and after pressure on sternum \& drain mobilization every 6 hours
  • Post extubation still drains VAS scale rest and Mob (sitting in bed moving thorax) ASAP after extubation and every 6h
  • Localization of the pain VAS Sternum Back pain Drains
  • After drains removed VAS rest and Mob ( sitting in bed moving thorax) and pain localization Pain (VAS rest ) just after Mediastinal drain removal if possible; Pain (VAS rest and mob every 8 h) in the ward; Pain at one month (VAS rest and mob).
  1. Discharge from hospital: (criteria discharge appendix 1)
Being tested
Regional analgesia
Keywords
Erector spinae Catheter, Enhanced Recovery after Cardiac Surgery, Peri operative regional analgesia for open heart surgery, Quality of recovery

What participants receive

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

  • Regional analgesiaProcedure or surgery

    Insertion of bilateral ESP catheters

Study groups in NCT04506762
Study groupRoleWhat they receive
ControlNo interventionStandard of care for peri operative analgesia
InterventionExperimentalBilateral ESP catheters for peri operative regional analgesia
Receives: Procedure: Regional analgesia

What is being measured

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

  1. Length of post operative stay in Hospital

    Duration of hospitalisation

    Measured: 10 days

Secondary outcomes (3)
  1. Length of post operative stay in Intensive care unit

    Duration of stay in Intensive care unit

    Measured: 3 days

  2. Time to 1st mobilisation

    1st Time to stand up out of bed

    Measured: 3 days

  3. Quality of recovery

    Quality of recovery using the scale QOR 16

    Measured: 1 month

Timeline

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

  1. First posted10 Aug 2020
  2. Study start1 Nov 2020
  3. Primary completion14 Aug 2023
  4. Study completion14 Aug 2023

Why it stopped: Surgical team resigned from our hospital

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
Randomised
Intervention model
Parallel groups
Model description
Randomized Prospective Controled
Masking
None (open label)
Enrolment
20 participants (actual)
IDs, dates and publications
ClinicalTrials.gov ID
NCT04506762
Sponsor's protocol ID
ESP ERCS
Acronym
ESP_ERCS
Status last verified
Aug 2023
First submitted
4 Aug 2020
Last updated
18 Aug 2023
Results posted
No
Data monitoring committee
Yes
FDA-regulated drug
No
FDA-regulated device
No
Individual data sharing
No

Publications

  • Noss C, Prusinkiewicz C, Nelson G, Patel PA, Augoustides JG, Gregory AJ. Enhanced Recovery for Cardiac Surgery. J Cardiothorac Vasc Anesth. 2018 Dec;32(6):2760-2770. doi: 10.1053/j.jvca.2018.01.045. Epub 2018 Jan 31.

    PubMed 29503121
  • Brown JK, Singh K, Dumitru R, Chan E, Kim MP. The Benefits of Enhanced Recovery After Surgery Programs and Their Application in Cardiothoracic Surgery. Methodist Debakey Cardiovasc J. 2018 Apr-Jun;14(2):77-88. doi: 10.14797/mdcj-14-2-77.

    PubMed 29977464
  • Williams JB, McConnell G, Allender JE, Woltz P, Kane K, Smith PK, Engelman DT, Bradford WT. One-year results from the first US-based enhanced recovery after cardiac surgery (ERAS Cardiac) program. J Thorac Cardiovasc Surg. 2019 May;157(5):1881-1888. doi: 10.1016/j.jtcvs.2018.10.164. Epub 2018 Dec 8.

    PubMed 30665758
  • Macaire P, Ho N, Nguyen T, Nguyen B, Vu V, Quach C, Roques V, Capdevila X. Ultrasound-Guided Continuous Thoracic Erector Spinae Plane Block Within an Enhanced Recovery Program Is Associated with Decreased Opioid Consumption and Improved Patient Postoperative Rehabilitation After Open Cardiac Surgery-A Patient-Matched, Controlled Before-and-After Study. J Cardiothorac Vasc Anesth. 2019 Jun;33(6):1659-1667. doi: 10.1053/j.jvca.2018.11.021. Epub 2018 Nov 19.

    PubMed 30665850
  • Milgrom LB, Brooks JA, Qi R, Bunnell K, Wuestfeld S, Beckman D. Pain levels experienced with activities after cardiac surgery. Am J Crit Care. 2004 Mar;13(2):116-25.

    PubMed 15043239
  • Lahtinen P, Kokki H, Hynynen M. Pain after cardiac surgery: a prospective cohort study of 1-year incidence and intensity. Anesthesiology. 2006 Oct;105(4):794-800. doi: 10.1097/00000542-200610000-00026.

    PubMed 17006079
  • Wick EC, Grant MC, Wu CL. Postoperative Multimodal Analgesia Pain Management With Nonopioid Analgesics and Techniques: A Review. JAMA Surg. 2017 Jul 1;152(7):691-697. doi: 10.1001/jamasurg.2017.0898.

    PubMed 28564673
  • Bigeleisen PE, Goehner N. Novel approaches in pain management in cardiac surgery. Curr Opin Anaesthesiol. 2015 Feb;28(1):89-94. doi: 10.1097/ACO.0000000000000147.

    PubMed 25500688
  • Bignami E, Castella A, Allegri M. Postoperative Pain After Cardiac Surgery: An Open Issue. J Cardiothorac Vasc Anesth. 2018 Feb;32(1):e24-e25. doi: 10.1053/j.jvca.2017.09.022. Epub 2017 Sep 20. No abstract available.

    PubMed 29217242
  • Carli F, Kehlet H, Baldini G, Steel A, McRae K, Slinger P, Hemmerling T, Salinas F, Neal JM. Evidence basis for regional anesthesia in multidisciplinary fast-track surgical care pathways. Reg Anesth Pain Med. 2011 Jan-Feb;36(1):63-72. doi: 10.1097/AAP.0b013e31820307f7.

    PubMed 22002193
  • Wong WT, Lai VK, Chee YE, Lee A. Fast-track cardiac care for adult cardiac surgical patients. Cochrane Database Syst Rev. 2016 Sep 12;9(9):CD003587. doi: 10.1002/14651858.CD003587.pub3.

    PubMed 27616189
  • Zhu F, Lee A, Chee YE. Fast-track cardiac care for adult cardiac surgical patients. Cochrane Database Syst Rev. 2012 Oct 17;10:CD003587. doi: 10.1002/14651858.CD003587.pub2.

    PubMed 23076899
  • Krishna SN, Chauhan S, Bhoi D, Kaushal B, Hasija S, Sangdup T, Bisoi AK. Bilateral Erector Spinae Plane Block for Acute Post-Surgical Pain in Adult Cardiac Surgical Patients: A Randomized Controlled Trial. J Cardiothorac Vasc Anesth. 2019 Feb;33(2):368-375. doi: 10.1053/j.jvca.2018.05.050. Epub 2018 Jun 4.

    PubMed 30055991
  • Ljungqvist O, Scott M, Fearon KC. Enhanced Recovery After Surgery: A Review. JAMA Surg. 2017 Mar 1;152(3):292-298. doi: 10.1001/jamasurg.2016.4952.

    PubMed 28097305
  • Nicholson A, Lowe MC, Parker J, Lewis SR, Alderson P, Smith AF. Systematic review and meta-analysis of enhanced recovery programmes in surgical patients. Br J Surg. 2014 Feb;101(3):172-88. doi: 10.1002/bjs.9394.

    PubMed 24469618

Questions about this trial

What is this clinical trial studying?

A study testing Regional analgesia in people with Open Heart Surgery, 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 9 inclusion and 15 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: stopped early, as of the sponsor's last update on 18 Aug 2023. 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 was stopped early (reason given: Surgical team resigned from our hospital). Results are not available in the source record.

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?

Length of post operative stay in Hospital (time frame: 10 days). It is what the study was designed to measure, not a finding.

Where can I read the original study information?

On the ClinicalTrials.gov record for NCT04506762, which also lists 18 linked publications.

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 18 Aug 2023.

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