Phase 4
N=93
Parasternal Nerve Block Using Bupivacaine for Postoperative Analgesia in Children Undergoing Cardiac Surgery
Pain
Bottom Line
View on ClinicalTrials.gov: NCT02512861 ↗Enrolled (actual)
93
Serious AEs
11.5%
Results posted
Aug 2018
Primary outcome: Primary: Total Fentanyl/Equivalent Day 0-1 — 23.6; 22.4 mcg/kg/day
Study Design & Population
- Study type
- Interventional
- Phase
- Phase 4
- Interventions
- Bupivacaine (Drug); Placebo (Drug)
- Age
- Pediatric
- Sex
- All
- Sponsor
- Children's Hospitals and Clinics of Minnesota
- Primary completion
- Oct 2015
Outcome Measures
| Outcome | Result | p-value |
|---|---|---|
| PRIMARY Total Fentanyl/Equivalent Day 0-1 |
23.6; 22.4 | — |
| PRIMARY Patient-Controlled Analgesia (PCA) Fentanyl/Equivalent Day 0-1 |
15.7; 14.6 | — |
| SECONDARY Postoperative Length of Intubation |
5.9; 6.4 | — |
| SECONDARY Postoperative Cortisol Levels |
9.4; 9.1 | — |
| SECONDARY Postoperative Pain Scores-Face, Legs, Activity, Cry, Consolability (FLACC) Scale |
0; 0 | — |
| SECONDARY Postoperative Pain Scores-State Behavioral Scale (SBS) |
-0.25; -0.25 | — |
| SECONDARY Postoperative Cortisol Levels |
9.4; 9.1 | — |
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.
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
Data sourced from ClinicalTrials.gov (NCT02512861). Outcome figures and adverse-event rates are extracted automatically from the registry's posted results and are provided for clinician reference, not as a substitute for the primary publication.