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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.
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.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Bupivacaine | Active Comparator | Bupivacaine as a parasternal nerve block following pediatric cardiothoracic surgery |
|
| Placebo | Placebo Comparator | Normal Saline |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| 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 |
| Measure | Description | Time Frame |
|---|---|---|
| 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 |
| Measure | Description | Time Frame |
|---|---|---|
| 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 |
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Inclusion Criteria:
Exclusion Criteria:
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| Name | Affiliation | Role |
|---|---|---|
| Francis X Moga, MD | Children's Hospitals and Clinics of Minnesota | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Children's Hospitals and Clinics of Minnesota | Minneapolis | Minnesota | 55404 | United States |
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| ID | Title | Description |
|---|---|---|
| FG000 | Bupivacaine | Bupivacaine as a parasternal nerve block following pediatric cardiothoracic surgery 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 |
| FG001 | Placebo | Normal Saline 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 |
| Title | Milestones | Reasons Not Completed | |||||||||||||||||||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Overall Study |
|
|
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| ID | Title | Description |
|---|---|---|
| BG000 | Bupivacaine | Bupivacaine as a parasternal nerve block following pediatric cardiothoracic surgery 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 |
| Units | Counts |
|---|---|
| Participants |
|
| Title | Description | Population Description | Parameter Type | Dispersion Type | Unit of Measure | Calculate Percentage | Denominator Units Selected | Denominators | Classes |
|---|---|---|---|---|---|---|---|---|---|
| Age, Continuous | Median |
| Type | Title | Description | Population Description | Reporting Status | Anticipated Posting Date | Parameter Type | Dispersion Type | Unit of Measure | Calculate Percentage | Time Frame | Units Analyzed | Denominator Units Selected | Arm/Group Information | Denominators | Classes | Analyses | ||||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Primary | Total Fentanyl/Equivalent Day 0-1 | Posted | Median | Inter-Quartile Range | mcg/kg/day | Day of Surgery and Postoperative Day 1 |
|
Adverse event data was collected over the first five post-operative days.
The method for collecting adverse event information was via daily collection form/questionnaire by the study coordinator for the first five post-operative days.
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| ID | Title | Description | Deaths (Affected) | Deaths (At Risk) | Serious Events (Affected) | Serious Events (At Risk) | Other Events (Affected) | Other Events (At Risk) |
|---|---|---|---|---|---|---|---|---|
| EG000 | Bupivacaine | Bupivacaine as a parasternal nerve block following pediatric cardiothoracic surgery 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 |
| Term | Organ System | Source Vocabulary | Assessment Type | Notes | Statistical Information |
|---|---|---|---|---|---|
| Shallow Breathing/Increased Work of Breathing | Respiratory, thoracic and mediastinal disorders | Systematic Assessment | Patient required either non-invasive respiratory support or reintubation |
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| Title | Organization | Phone | Extension | |
|---|---|---|---|---|
| Mark Lo Galbo, MPH, CCRP | Children's Hospitals and Clinics of Minnesota | (612)-813-7828 | mark.logalbo@childrensmn.org |
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| ID | Term |
|---|---|
| D010146 | Pain |
| ID | Term |
|---|---|
| D009461 | Neurologic Manifestations |
| D012816 | Signs and Symptoms |
| D013568 | Pathological Conditions, Signs and Symptoms |
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| ID | Term |
|---|---|
| D002045 | Bupivacaine |
| D000077330 | Saline Solution |
| ID | Term |
|---|---|
| D000813 | Anilides |
| D000577 | Amides |
| D009930 | Organic Chemicals |
| D000814 | Aniline Compounds |
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|
|
| 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 |
|
|
Face, Legs, Activity, Cry, Consolability (FLACC) scale: range is from 0 to 10 and a higher score indicates greater level of pain (worse outcome). |
| Day of Surgery |
| Postoperative Pain Scores-State Behavioral Scale (SBS) | State Behavioral Scale (SBS): range is from -3 to 2. A higher score indicates a patient is more uncomfortable and agitated (worse outcome). | Day of Surgery |
| Postoperative Cortisol Levels | 36 hours post-surgery |
| Withdrawal by Subject |
|
| BG001 | Placebo | Normal Saline 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 |
| BG002 | Total | Total of all reporting groups |
| years |
|
| Sex: Female, Male | Count of Participants | Participants |
|
| Race/Ethnicity, Customized | Count of Participants | Participants |
|
| Region of Enrollment | Number | participants |
|
| Comorbidities | Any additional medical conditions that the patient had in addition to the cardiac defect were collected and categorized into the following:
| Count of Participants | Participants |
|
|
|
| Primary | Patient-Controlled Analgesia (PCA) Fentanyl/Equivalent Day 0-1 | Posted | Median | Inter-Quartile Range | mcg/kg/day | Day of Surgery and Postoperative Day 1 |
|
|
|
| Secondary | Postoperative Length of Intubation | Posted | Median | Inter-Quartile Range | hours | 5 days post cardiac surgery |
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| Secondary | Postoperative Cortisol Levels | Posted | Median | Inter-Quartile Range | microgram/deciliter | 12 hours post-surgery |
|
|
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| Secondary | Postoperative Pain Scores-Face, Legs, Activity, Cry, Consolability (FLACC) Scale | Face, Legs, Activity, Cry, Consolability (FLACC) scale: range is from 0 to 10 and a higher score indicates greater level of pain (worse outcome). | Posted | Median | Inter-Quartile Range | score on a scale | Day of Surgery |
|
|
|
| Secondary | Postoperative Pain Scores-State Behavioral Scale (SBS) | State Behavioral Scale (SBS): range is from -3 to 2. A higher score indicates a patient is more uncomfortable and agitated (worse outcome). | Posted | Median | Inter-Quartile Range | score on a scale | Day of Surgery |
|
|
|
| Secondary | Postoperative Cortisol Levels | Posted | Median | Inter-Quartile Range | microgram/deciliter | 36 hours post-surgery |
|
|
|
| 0 |
| 38 |
| 3 |
| 38 |
| 0 |
| 38 |
| EG001 | Placebo | Normal Saline 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 | 0 | 40 | 6 | 40 | 0 | 40 |
|
| Significant blood/chest tube losses requiring transfusion or fluid resuscitation | Blood and lymphatic system disorders | Systematic Assessment |
|
| Pneumothorax or Pleural effusion | Respiratory, thoracic and mediastinal disorders | Systematic Assessment | Patient required reinitiation of chest tubes |
|
| Acute respiratory syncytial virus leading to pneumonia | Respiratory, thoracic and mediastinal disorders | Systematic Assessment |
|
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| D000588 |
| Amines |
| D000077324 | Crystalloid Solutions |
| D007552 | Isotonic Solutions |
| D012996 | Solutions |
| D004364 | Pharmaceutical Preparations |