NCT03593642

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 .

Trial Health

87
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
40

participants targeted

Target at P25-P50 for not_applicable

Timeline
Completed

Started Oct 2018

Shorter than P25 for not_applicable

Geographic Reach
1 country

1 active site

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

First Submitted

Initial submission to the registry

June 8, 2018

Completed
1 month until next milestone

First Posted

Study publicly available on registry

July 20, 2018

Completed
2 months until next milestone

Study Start

First participant enrolled

October 1, 2018

Completed
6 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

April 1, 2019

Completed
3 months until next milestone

Study Completion

Last participant's last visit for all outcomes

June 30, 2019

Completed
Last Updated

February 24, 2020

Status Verified

February 1, 2020

Enrollment Period

6 months

First QC Date

June 8, 2018

Last Update Submit

February 20, 2020

Conditions

Opioid UsePain, PostoperativeQuality of Life

Outcome Measures

Primary Outcomes (1)

  • morphine consumption

    Total consumption of rescue analgesia by morphine (mcg/kg)

    48 hours after arrival in Intensive care unit

Secondary Outcomes (3)

  • pain after extubation at rest

    2 hours after extubation at day 1

  • pain after extubation at mobilisation seating in the bed

    2 hours after extubation at day 1

  • Persistent pain at 1 month

    Consultation 1 month after the surgery

Study Arms (2)

Control Group

PLACEBO COMPARATOR

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

Regional analgesia group

EXPERIMENTAL

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

Interventions

Continuous infusion of ropivacain in ESP catheterDRUG

administration of ropivacaine in ESP catheter to provide regional analgesia after surgery

Regional analgesia group
Continuous infusion of Iso Saline in ESP catheterDRUG

administration of Iso Saline in ESP catheter to be the control group

Control Group

Eligibility Criteria

Age2 Months - 10 Years
Sexall
Healthy VolunteersNo
Age GroupsChild (0-17)

You may qualify if:

  • Elective open heart surgery

You may not qualify if:

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

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Vinmec Central Park

Ho Chi Minh City, Ho Chi Minh, 100000, Vietnam

Location

Related Publications (11)

  • Garg R, Rao S, John C, Reddy C, Hegde R, Murthy K, Prakash PV. Extubation in the operating room after cardiac surgery in children: a prospective observational study with multidisciplinary coordinated approach. J Cardiothorac Vasc Anesth. 2014 Jun;28(3):479-87. doi: 10.1053/j.jvca.2014.01.003. Epub 2014 Apr 18.

    PMID: 24746595BACKGROUND

  • Heinle JS, Diaz LK, Fox LS. Early extubation after cardiac operations in neonates and young infants. J Thorac Cardiovasc Surg. 1997 Sep;114(3):413-8. doi: 10.1016/S0022-5223(97)70187-9.

    PMID: 9305193BACKGROUND

  • Kin N, Weismann C, Srivastava S, Chakravarti S, Bodian C, Hossain S, Krol M, Hollinger I, Nguyen K, Mittnacht AJ. Factors affecting the decision to defer endotracheal extubation after surgery for congenital heart disease: a prospective observational study. Anesth Analg. 2011 Aug;113(2):329-35. doi: 10.1213/ANE.0b013e31821cd236. Epub 2011 Apr 13.

    PMID: 21490084BACKGROUND

  • 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.

    PMID: 22002193BACKGROUND

  • Munoz F, Cubillos J, Bonilla AJ, Chin KJ. Erector spinae plane block for postoperative analgesia in pediatric oncological thoracic surgery. Can J Anaesth. 2017 Aug;64(8):880-882. doi: 10.1007/s12630-017-0894-0. Epub 2017 Apr 26. No abstract available.

    PMID: 28447318BACKGROUND

  • 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

    BACKGROUND

  • Tsui BCH, Navaratnam M, Boltz G, Maeda K, Caruso TJ. Bilateral automatized intermittent bolus erector spinae plane analgesic blocks for sternotomy in a cardiac patient who underwent cardiopulmonary bypass: A new era of Cardiac Regional Anesthesia. J Clin Anesth. 2018 Aug;48:9-10. doi: 10.1016/j.jclinane.2018.04.005. Epub 2018 May 26. No abstract available.

    PMID: 29684728BACKGROUND

  • Biswas A, Luginbuehl I, Szabo E, Caldeira-Kulbakas M, Crawford MW, Everett T. Use of Serratus Plane Block for Repair of Coarctation of Aorta: A Report of 3 Cases. Reg Anesth Pain Med. 2018 Aug;43(6):641-643. doi: 10.1097/AAP.0000000000000801.

    PMID: 29794944BACKGROUND

  • 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/

    BACKGROUND

  • Alghamdi AA, Singh SK, Hamilton BC, Yadava M, Holtby H, Van Arsdell GS, Al-Radi OO. Early extubation after pediatric cardiac surgery: systematic review, meta-analysis, and evidence-based recommendations. J Card Surg. 2010 Sep;25(5):586-95. doi: 10.1111/j.1540-8191.2010.01088.x.

    PMID: 20626510RESULT

  • Macaire P, Ho N, Nguyen V, Phan Van H, Dinh Nguyen Thien K, Bringuier S, Capdevila X. Bilateral ultrasound-guided thoracic erector spinae plane blocks using a programmed intermittent bolus improve opioid-sparing postoperative analgesia in pediatric patients after open cardiac surgery: a randomized, double-blind, placebo-controlled trial. Reg Anesth Pain Med. 2020 Oct;45(10):805-812. doi: 10.1136/rapm-2020-101496. Epub 2020 Aug 19.

    PMID: 32817407DERIVED

MeSH Terms

Conditions

Pain, Postoperative

Condition Hierarchy (Ancestors)

Postoperative ComplicationsPathologic ProcessesPathological Conditions, Signs and SymptomsPainNeurologic ManifestationsSigns and Symptoms

Study Design

Study Type
interventional
Phase
not applicable
Allocation
RANDOMIZED
Masking
QUADRUPLE
Who Masked
PARTICIPANT, CARE PROVIDER, INVESTIGATOR, OUTCOMES ASSESSOR
Masking Details
Double blinded
Purpose
TREATMENT
Intervention Model
PARALLEL
Model Details: Randomized controlled
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
Professor in Anesthesiology and Pain

Study Record Dates

First Submitted

June 8, 2018

First Posted

July 20, 2018

Study Start

October 1, 2018

Primary Completion

April 1, 2019

Study Completion

June 30, 2019

Last Updated

February 24, 2020

Record last verified: 2020-02

Locations

VN(1)