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ESP Catheter Vs Single Shot ESP for Open Heart Surgery in Infants (ESPINFANT)

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
 
ClinicalTrials.gov Identifier: NCT03593642
Recruitment Status : Completed
First Posted : July 20, 2018
Last Update Posted : February 24, 2020
Sponsor:
Information provided by (Responsible Party):
Philippe Macaire, Vinmec Healthcare System

Brief Summary:

Post operative pain after open heart surgery is still a main concern; current multimodal analgesia modalities have shown good efficacy for postoperative pain at rest, without reaching full pain relief.

The primary goal of this study is to evaluate the effectiveness of peri-operative analgesia, measured by consumption of opioids during the first 48h hours after the surgery, using bilateral erector spinae catheters for 48h, compared to single shot erector spinae block in pediatric patients undergoing open heart surgeries .


Condition or disease Intervention/treatment Phase
Opioid Use Pain, Postoperative Quality of Life Drug: Continuous infusion of ropivacain in ESP catheter Drug: Continuous infusion of Iso Saline in ESP catheter Not Applicable

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Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 40 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Intervention Model Description: Randomized controlled
Masking: Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
Masking Description: Double blinded
Primary Purpose: Treatment
Official Title: Bilateral Erector Spinae Plane (ESP) Catheters Versus Single Shot ESP Block for Open Heart Surgery in Infants
Actual Study Start Date : October 1, 2018
Actual Primary Completion Date : April 1, 2019
Actual Study Completion Date : June 30, 2019

Resource links provided by the National Library of Medicine

MedlinePlus related topics: Heart Surgery

Arm Intervention/treatment
Placebo Comparator: Control Group
Erector spinae bilateral catheters with continuous infusion iso saline during 48h after surgery Day 0 to day 2
Drug: Continuous infusion of Iso Saline in ESP catheter
administration of Iso Saline in ESP catheter to be the control group

Experimental: Regional analgesia group
Erector spinae bilateral catheters with continuous infusion Ropivacaine 0.1 or 0.2%, depending on age, infusion during 48h after surgeryDay 0 to day 2
Drug: Continuous infusion of ropivacain in ESP catheter
administration of ropivacaine in ESP catheter to provide regional analgesia after surgery




Primary Outcome Measures :
  1. morphine consumption [ Time Frame: 48 hours after arrival in Intensive care unit ]
    Total consumption of rescue analgesia by morphine (mcg/kg)


Secondary Outcome Measures :
  1. pain after extubation at rest [ Time Frame: 2 hours after extubation at day 1 ]
    Flacc Scale to evaluate pain in Infants from 0 no pain to 10 maximal pain

  2. pain after extubation at mobilisation seating in the bed [ Time Frame: 2 hours after extubation at day 1 ]
    Flacc Scale to evaluate pain in Infants from 0 no pain to 10 maximal pain

  3. Persistent pain at 1 month [ Time Frame: Consultation 1 month after the surgery ]
    Flacc Scale to evaluate pain in Infants from 0 no pain to 10 maximal pain Mobilisation and rest



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Ages Eligible for Study:   2 Months to 10 Years   (Child)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Criteria

Inclusion Criteria:

  • Elective open heart surgery

Exclusion Criteria:

  • Consent refusal
  • Urgent surgery
  • unstable hemodynamic patient after anesthesia induction

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT03593642


Locations
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Vietnam
Vinmec Central Park
Ho Chi Minh City, Ho Chi Minh, Vietnam, 100000
Sponsors and Collaborators
Vinmec Healthcare System
Publications of Results:
Other Publications:
Nga Ho, Binh Nguyen, Tan Nguyen, Viet Vu, Chinh Quach, Vincente Rocques, Philippe Macaire Analgesia opioid free with Bilateral ESP catheters for open heart Surgeries in Adults RAPM 2018 ASRA 277
Referentiels Societe Francaise d'Anesthesie Reanimation (SFAR) ALR pediatrique 2010 and Association des Anesthesistes reanimateurs Pediatriques Francophones ADARPEF http://sfar.org/anesthesie-loco-regionale-en-pediatrie/

Publications automatically indexed to this study by ClinicalTrials.gov Identifier (NCT Number):
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Responsible Party: Philippe Macaire, Professor in Anesthesiology and Pain, Vinmec Healthcare System
ClinicalTrials.gov Identifier: NCT03593642    
Other Study ID Numbers: vinmechs
First Posted: July 20, 2018    Key Record Dates
Last Update Posted: February 24, 2020
Last Verified: February 2020

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Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: No
Additional relevant MeSH terms:
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Pain, Postoperative
Postoperative Complications
Pathologic Processes
Pain
Neurologic Manifestations