Clinical trial NCT02512861: Parasternal Nerve Block Using Bupivacaine for Postoperative Analgesia in Children Undergoing Cardiac Surgery
Official title: Parasternal Nerve Block Using Bupivacaine for Postoperative Analgesia in Children Undergoing Cardiac Surgery: A Prospective: Double-Blind, Randomized Controlled Trial
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE4
Conditions: Pain
Keywords: Bupivacaine
Cardiac Surgery
Pediatrics
Nerve Block
Lead sponsor: Children's Hospitals and Clinics of Minnesota
Sponsor class: OTHER
First posted: 2015-07-31
Enrollment: 93
Sex: ALL
Maximum age (years): 17
Standard ages: CHILD
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

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.

Eligibility criteria: 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

Primary outcomes:
measure: Total Fentanyl/Equivalent Day 0-1
timeFrame: Day of Surgery and Postoperative Day 1
measure: Patient-Controlled Analgesia (PCA) Fentanyl/Equivalent Day 0-1
timeFrame: Day of Surgery and Postoperative Day 1
Secondary outcomes:
measure: Postoperative Length of Intubation
timeFrame: 5 days post cardiac surgery
measure: Postoperative Cortisol Levels
timeFrame: 12 hours post-surgery
measure: Postoperative Pain Scores-Face, Legs, Activity, Cry, Consolability (FLACC) Scale
timeFrame: Day of Surgery
measure: Postoperative Pain Scores-State Behavioral Scale (SBS)
timeFrame: Day of Surgery
measure: Postoperative Cortisol Levels
timeFrame: 36 hours post-surgery
Other outcomes:
Locations:
city: Minneapolis
country: United States
facility: Children's Hospitals and Clinics of Minnesota
state: Minnesota
Study officials:
affiliation: Children's Hospitals and Clinics of Minnesota
name: Francis X Moga, MD
role: PRINCIPAL_INVESTIGATOR
References: