CI

At a glance

ClinicalIndex Comparison Record
Phase 4Completed· 93 enrolled
Drug / intervention
Bupivacaine +1 moredrug
Likely dose
Bupivacaine 1mlfrom record
Structured eligibility isn't available for this trial yet — see the full criteria in the Eligibility tab below.

Standardized by ClinicalIndex from the ClinicalTrials.gov record · verify against the source.

Search/NCT02512861
NCT02512861Phase 4Completed

Parasternal Nerve Block Using Bupivacaine for Postoperative Analgesia in Children Undergoing Cardiac Surgery: A Prospective: Double-Blind, Randomized Controlled Trial

Children's Hospitals and Clinics of Minnesota·interventional·Posted Jul 31, 2015·Updated Aug 22, 2018

In Brief

A Phase 4 clinical trial evaluating Bupivacaine and Placebo for Pain. Completed, enrolled 93 participants across 1 site.

Detailed 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.

Study Details

Study Typeinterventional
Allocation--
Masking--
Primary Purpose--
ConditionsPain
CountriesUnited States
Collaborators--

Timeline

Phase 4CompletedFinished
2014201520162017201820192020202120222023202420252026
First PostedJul 31, 2015
Enrollment StartApr 1, 2014
Primary CompletionOct 1, 2015
Study CompletionNov 1, 2015
TodayJul 2, 2026
Enrollment to primary: 1.5 yearsPosted 10.9 years ago

Interventions

Bupivacainedrug

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

Placebodrug

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