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Parasternal Nerve Block Using Bupivacaine for Postoperative Analgesia in Children Undergoing Cardiac Surgery

NCT02512861 · Status: COMPLETED · Phase: PHASE4 · Type: INTERVENTIONAL · Enrollment: 93

Last updated 2018-08-22

Study results available
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Summary

All pediatric patients who undergo cardiac surgery require analgesic medications for postoperative pain control and many require sedation to facilitate comfort with cares. Parasternal infiltration of local anesthetic for nerve blocks is a simple option to postoperative analgesia. The investigators hypothesize that Bupivacaine, a parasternal nerve block administered in pediatric patients undergoing cardiac surgery will reduce the requirement of Opioids and other pain medications as well as decrease postoperative pain scores. This is a prospective, double-blind, randomized controlled trial. Subjects are randomized to receive either 0.25% Bupivacaine or normal saline following their cardiothoracic surgery.

Conditions

Interventions

DRUG

Bupivacaine

Bupivacaine will be administered bilaterally to the parasternal intercostal spaces during surgery according to these doses: Under 20kgs weight: 0.25% Bupivacaine at 1 milliliter/kilogram (1ml/kg); Above 20kgs weight: 0.5% Bupivacaine at 0.5 ml/kg up to a maximum of 25ml of 0.5% Bupivacaine for patients \> 50 kgs

DRUG

Placebo

Saline will be administered bilaterally to the parasternal intercostal spaces during surgery according to these doses: Under 20kgs weight: 1 milliliter/kilogram (1ml/kg); Above 20kgs weight: 0.5 ml/kg up to a maximum of 25ml for patients \> 50 kgs

Sponsors & Collaborators

  • Children's Hospitals and Clinics of Minnesota

    lead OTHER

Principal Investigators

  • Francis X Moga, MD · Children's Hospitals and Clinics of Minnesota

Study Design

Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
TRIPLE
Model
PARALLEL

Eligibility

Max Age
17 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2014-04-30
Primary Completion
2015-10-31
Completion
2015-11-30

Countries

  • United States

Study Locations

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Entities

Drugs
Diseases

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 NCT02512861 on ClinicalTrials.gov