Overview

This trial is active, not recruiting.

Condition pain
Treatments bupivacaine, placebo
Phase phase 4
Sponsor Children's Hospitals and Clinics of Minnesota
Start date April 2014
End date October 2015
Trial size 93 participants
Trial identifier NCT02512861, 1311-105

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.

United States No locations recruiting
Other Countries No locations recruiting

Study Design

Allocation randomized
Endpoint classification efficacy study
Intervention model parallel assignment
Masking double blind (subject, caregiver, investigator)
Primary purpose treatment
Arm
(Active Comparator)
Bupivacaine as a parasternal nerve block following pediatric cardiothoracic surgery
bupivacaine Marcaine
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
(Placebo Comparator)
Normal Saline
placebo Normal Saline
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

Primary Outcomes

Measure
Postoperative pain medication dose
time frame: 5 days post cardiac surgery

Secondary Outcomes

Measure
Postoperative length of intubation
time frame: 5 days post cardiac surgery
Postoperative cortisol levels
time frame: 12, 36 hours post surgery
Postoperative pain scores- FACES
time frame: 5 days post cardiac surgery
Postoperative pain scores- FLACC
time frame: 5 days post cardiac surgery
Postoperative pain scores- WAT-1
time frame: 5 days post cardiac surgery
Postoperative pain scores- SBS
time frame: 5 days post cardiac surgery

Eligibility Criteria

Male or female participants up to 17 years old.

Inclusion Criteria: - Age 0-17 years old at time of surgery - STAT (Society of Thoracic Surgeons - European Association for Cardio-Thoracic Surgery Congenital Heart Surgery) mortality categories 1-3 - Surgical intervention requiring median sternotomy - Expected extubation within 24 hours of surgery Exclusion Criteria: - Known allergic reaction or hypersensitivity to Bupivacaine or to any local anesthetic agent of the amide type - Delayed sternum closure

Additional Information

Official title Parasternal Nerve Block Using Bupivacaine for Postoperative Analgesia in Children Undergoing Cardiac Surgery: A Prospective: Double-Blind, Randomized Controlled Trial
Principal investigator Francis X Moga, MD
Description One of the most challenging struggles in clinical practices in pediatric cardiac intensive care units is the provision of optimal and safe postoperative analgesia and sedation. 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. Bupivacaine is a local anesthetic that can be injected into the intercostal spaces on each side of a sternotomy to induce nerve block. The purpose of this study is to evaluate whether the use of Bupivacaine as a nerve block in children undergoing cardiothoracic surgery will reduce postoperative pain medication use and decrease postoperative pain scores. The investigators hypothesize that the administration of Bupivacaine bilaterally into the posterior intercostal spaces on each side of a sternotomy following cardiothoracic surgery will reduce the requirement of pain medications as well as decrease postoperative pain scores. This is a prospective, randomized, double-blind, control study. Subjects are randomized into two arms: those who receive 0.25% Bupivacaine and those who receive placebo (normal saline). Subjects receive 1 milliliter per kilogram up to 20 kilograms, then 0.5 milliliters per kilogram up to 50 kilograms of study drug. Subjects are followed for 5 days postoperatively, then on day of discharge. Pain medication administered and FLACC (Face, Legs, Activity, Cry, Consolability) scores are recorded daily for 5 days.
Trial information was received from ClinicalTrials.gov and was last updated in June 2016.
Information provided to ClinicalTrials.gov by Children's Hospitals and Clinics of Minnesota.