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

Phase 4

Completed

• Conditions: Pain
• Interventions: Drug: Placebo; Drug: Bupivacaine

• Registration Number: NCT02512861
• Lead Sponsor: Children's Hospitals and Clinics of Minnesota

Brief 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.

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 Timeline

• Study Start: 2014-04
• Study First Submitted: 2014-06-06
• Study First Submitted QC: 2015-07-30
• Study First Posted: 2015-07-31
• Primary Completion: 2015-10
• Study Completion: 2015-11
• Results First Submitted: 2018-01-24
• Status Verified: 2018-08
• Results First Submitted QC: 2018-08-20
• Last Update Submitted: 2018-08-20
• Results First Posted: 2018-08-22
• Last Update Posted: 2018-08-22

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 93

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 & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
Placebo	Placebo	Normal Saline
Bupivacaine	Bupivacaine	Bupivacaine as a parasternal nerve block following pediatric cardiothoracic surgery

Primary Outcome Measures

Name	Time	Method
Patient-Controlled Analgesia (PCA) Fentanyl/Equivalent Day 0-1	Day of Surgery and Postoperative Day 1
Total Fentanyl/Equivalent Day 0-1	Day of Surgery and Postoperative Day 1

Secondary Outcome Measures

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

Trial Locations

Locations (1)

Children's Hospitals and Clinics of Minnesota; 🇺🇸 Minneapolis, Minnesota, United States