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ESP Catheter Vs Single Shot ESP for Open Heart Surgery in Infants

NCT03593642 · Status: COMPLETED · Phase: NA · Type: INTERVENTIONAL · Enrollment: 40

Last updated 2020-02-24

No results posted yet for this study

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 .

Conditions

  • Opioid Use
  • Pain, Postoperative
  • Quality of Life

Interventions

DRUG

Continuous infusion of ropivacain in ESP catheter

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

DRUG

Continuous infusion of Iso Saline in ESP catheter

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

Sponsors & Collaborators

  • Vinmec Healthcare System

    lead OTHER

Study Design

Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
QUADRUPLE
Model
PARALLEL

Eligibility

Min Age
2 Months
Max Age
10 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2018-10-01
Primary Completion
2019-04-01
Completion
2019-06-30

Countries

  • Vietnam

Study Locations

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Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT03593642 on ClinicalTrials.gov