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

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

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 Overview

• Status: Completed
• Conditions: Pain
• Intervention / Treatment: Drug: Bupivacaine; Drug: Placebo

Detailed 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 Face, Legs, Activity, Cry, and Consolability (FLACC) scores are recorded daily for 5 days.

• Study Type: Interventional
• Enrollment (Actual): 93
• Phase: Phase 4

Contacts and Locations

Study Locations

• United States
  • Minnesota
    • Minneapolis, Minnesota, United States, 55404
      • Children's Hospitals and Clinics of Minnesota

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: No older than 17 years (CHILD)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: All

Description

Inclusion Criteria:

• Age 0-17 years old at time of surgery
• Society of Thoracic Surgeons- European Association for Cardio-Thoracic Surgery (STAT) 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

Study Plan

How is the study designed?

Design Details

• Primary Purpose: TREATMENT
• Allocation: RANDOMIZED
• Interventional Model: PARALLEL
• Masking: TRIPLE

Number of Arms

2

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
PLACEBO_COMPARATOR: Placebo; Normal Saline	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; Other Names: Normal Saline
ACTIVE_COMPARATOR: Bupivacaine; Bupivacaine as a parasternal nerve block following pediatric cardiothoracic surgery	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; Other Names: Marcaine; Sensorcaine

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Time Frame
Total Fentanyl/Equivalent Day 0-1	Day of Surgery and Postoperative Day 1
Patient-Controlled Analgesia (PCA) Fentanyl/Equivalent Day 0-1	Day of Surgery and Postoperative Day 1

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Postoperative Length of Intubation		5 days post cardiac surgery
Postoperative Cortisol Levels		12 hours post-surgery
Postoperative Pain Scores-Face, Legs, Activity, Cry, Consolability (FLACC) Scale	Face, Legs, Activity, Cry, Consolability (FLACC) scale: range is from 0 to 10 and a higher score indicates greater level of pain (worse outcome).	Day of Surgery
Postoperative Pain Scores-State Behavioral Scale (SBS)	State Behavioral Scale (SBS): range is from -3 to 2. A higher score indicates a patient is more uncomfortable and agitated (worse outcome).	Day of Surgery
Postoperative Cortisol Levels		36 hours post-surgery

Collaborators and Investigators

• Sponsor: Children's Hospitals and Clinics of Minnesota
• Investigators: Principal Investigator: Francis X Moga, MD, Children's Hospitals and Clinics of Minnesota

Study record dates

Study Major Dates

• Study Start: April 1, 2014
• Primary Completion (ACTUAL): October 1, 2015
• Study Completion (ACTUAL): November 1, 2015

Study Registration Dates

• First Submitted: June 6, 2014
• First Submitted That Met QC Criteria: July 30, 2015
• First Posted (ESTIMATE): July 31, 2015

Study Record Updates

• Last Update Posted (ACTUAL): August 22, 2018
• Last Update Submitted That Met QC Criteria: August 20, 2018
• Last Verified: August 1, 2018

More Information

Terms related to this study

• Keywords: Nerve Block; Pediatrics; Cardiac Surgery; Bupivacaine
• Additional Relevant MeSH Terms: Physiological Effects of Drugs; Central Nervous System Depressants; Peripheral Nervous System Agents; Sensory System Agents; Anesthetics; Anesthetics, Local; Bupivacaine
• Other Study ID Numbers: 1311-105