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

NCT02512861 | Completed Phase 4 Results DMC

• 1 other identifier: 1311-105
• Study Type: interventional
• Target: 93
• Locations: 1 country
• Sites: 1

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.

Conditions

Pain

Keywords

Bupivacaine; Cardiac Surgery; Pediatrics; Nerve Block

Outcome Measures

Primary Outcomes (2)

• Total Fentanyl/Equivalent Day 0-1

  Day of Surgery and Postoperative Day 1

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

  Day of Surgery and Postoperative Day 1

Secondary Outcomes (5)

• Postoperative Length of Intubation

  5 days post cardiac surgery

• Postoperative Cortisol Levels

  12 hours post-surgery

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

  Day of Surgery

• Postoperative Pain Scores-State Behavioral Scale (SBS)

  Day of Surgery

• Postoperative Cortisol Levels

  36 hours post-surgery

Study Arms (2)

Bupivacaine

ACTIVE COMPARATOR

Bupivacaine as a parasternal nerve block following pediatric cardiothoracic surgery

Drug: Bupivacaine

Placebo

PLACEBO COMPARATOR

Normal Saline

Drug: Placebo

Interventions

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

Also known as: Marcaine, Sensorcaine

Bupivacaine

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

Also known as: Normal Saline

Placebo

Eligibility Criteria

• Age: Up to 17 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Child (0-17)

You may qualify if:

• 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

You may not qualify if:

• Known allergic reaction or hypersensitivity to Bupivacaine or to any local anesthetic agent of the amide type
• Delayed sternum closure

Sponsors & Collaborators

• Children's Hospitals and Clinics of Minnesota: lead

Study Sites (1)

Children's Hospitals and Clinics of Minnesota

Minneapolis, Minnesota, 55404, United States

Location

MeSH Terms

Conditions

Pain

Interventions

Bupivacaine; Saline Solution

Condition Hierarchy (Ancestors)

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

Intervention Hierarchy (Ancestors)

Anilides; Amides; Organic Chemicals; Aniline Compounds; Amines; Crystalloid Solutions; Isotonic Solutions; Solutions; Pharmaceutical Preparations

Results Point of Contact

• Title: Mark Lo Galbo, MPH, CCRP
• Organization: Children's Hospitals and Clinics of Minnesota

mark.logalbo@childrensmn.org

(612)-813-7828

Study Officials

• Francis X Moga, MD

  Children's Hospitals and Clinics of Minnesota

  PRINCIPAL INVESTIGATOR

Publication Agreements

• PI is Sponsor Employee: Yes

Study Design

• Study Type: interventional
• Phase: phase 4
• Allocation: RANDOMIZED
• Masking: TRIPLE
• Who Masked: PARTICIPANT, CARE PROVIDER, INVESTIGATOR
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: June 6, 2014
• First Posted: July 31, 2015
• Study Start: April 1, 2014
• Primary Completion: October 1, 2015
• Study Completion: November 1, 2015
• Last Updated: August 22, 2018
• Results First Posted: August 22, 2018

Record last verified: 2018-08

Locations

US (1)