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NCT Number: NCT02512861

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

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.

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Key information

Conditions

Pain Neurologic Manifestations Pathological Conditions, Signs and Symptoms Signs and Symptoms

Age range

Up to 17 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Phase 4

Primary location

Children's Hospitals and Clinics of Minnesota

Minneapolis, Minnesota, 55404, United States

About this study

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.

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

Bupivacaine

Drug

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

Placebo

Drug

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

Primary outcomes

  1. Total Fentanyl/Equivalent Day 0-1

    Time frame: Day of Surgery and Postoperative Day 1

  2. Patient-Controlled Analgesia (PCA) Fentanyl/Equivalent Day 0-1

    Time frame: Day of Surgery and Postoperative Day 1

Secondary outcomes

  1. Postoperative Length of Intubation

    Time frame: 5 days post cardiac surgery

  2. Postoperative Cortisol Levels

    Time frame: 12 hours post-surgery

  3. Postoperative Pain Scores-Face, Legs, Activity, Cry, Consolability (FLACC) Scale

    Time frame: 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).

  4. Postoperative Pain Scores-State Behavioral Scale (SBS)

    Time frame: 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).

  5. Postoperative Cortisol Levels

    Time frame: 36 hours post-surgery

Sponsors and collaborators

Lead sponsor

Children's Hospitals and Clinics of Minnesota

Other

Registry information

Official study title

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

Important dates

Study start
2014
Primary completion
2015
Study completion
2015
First posted
Jul 31, 2015
Registry last updated
Aug 22, 2018

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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