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

Condition(s) targeted: Pain

Intervention: Bupivacaine (Drug); Placebo (Drug)

Phase: Phase 4

Status: Enrolling by invitation

Sponsored by: Children's Hospitals and Clinics of Minnesota

Official(s) and/or principal investigator(s):
Francis X Moga, MD, Principal Investigator, Affiliation: Children's Hospitals and Clinics of Minnesota

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.

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

Study design: Allocation: Randomized, Endpoint Classification: Efficacy Study, Intervention Model: Parallel Assignment, Masking: Double Blind (Subject, Caregiver, Investigator), Primary Purpose: Treatment

Primary outcome: Postoperative pain medication use

Secondary outcome:

Postoperative length of intubation

Postoperative cortisol levels

Postoperative pain scores

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

Minimum age: N/A. Maximum age: 17 Years. Gender(s): Both.

Criteria:

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

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

Starting date: April 2014
Last updated: July 30, 2015