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

NCT ID: NCT02512861

Last Updated: 2018-08-22

Basic Information

• Recruitment Status: COMPLETED
• Clinical Phase: PHASE4
• Total Enrollment: 93 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2014-04-30
• Study Completion Date: 2015-11-30

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.

Conditions

Pain

Study Design

• Allocation Method: RANDOMIZED
• Intervention Model: PARALLEL
• Primary Study Purpose: TREATMENT
• Blinding Strategy: TRIPLE

Study Groups

Bupivacaine

Bupivacaine as a parasternal nerve block following pediatric cardiothoracic surgery

Group Type: ACTIVE_COMPARATOR

Bupivacaine

Intervention Type: 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

Placebo

Normal Saline

Group Type: PLACEBO_COMPARATOR

Placebo

Intervention Type: 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

Interventions

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

Intervention Type: 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

Intervention Type: DRUG

Other Intervention Names

Marcaine; Sensorcaine; Normal Saline

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

• Maximum Eligible Age: 17 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

Children's Hospitals and Clinics of Minnesota

OTHER

Sponsor Role: lead

Responsible Party

Responsibility Role: SPONSOR

Principal Investigators

Francis X Moga, MD

Role: PRINCIPAL_INVESTIGATOR

Children's Hospitals and Clinics of Minnesota

Locations

Children's Hospitals and Clinics of Minnesota

Minneapolis, Minnesota, United States

Countries

United States

Other Identifiers

1311-105

Identifier Type: -

Identifier Source: org_study_id