Pain
Conditions
Keywords
Bupivacaine, Cardiac Surgery, Pediatrics, Nerve Block
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.
Interventions
DRUGBupivacaine
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
DRUGPlacebo
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
Sponsors
Children's Hospitals and Clinics of Minnesota
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT
Masking
TRIPLE (Subject, Caregiver, Investigator)
Eligibility
Sex/Gender
ALL
Age
No minimum to 17 Years
Healthy volunteers
No
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
Design outcomes
Primary
| Measure | 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 |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| Postoperative Pain Scores-Face, Legs, Activity, Cry, Consolability (FLACC) Scale | 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). |
| Postoperative Cortisol Levels | 12 hours post-surgery | — |
| Postoperative Length of Intubation | 5 days post cardiac surgery | — |
| Postoperative Pain Scores-State Behavioral Scale (SBS) | 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). |
Countries
United States
Participant flow
Participants by arm
| Arm | Count |
|---|---|
| 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 | 38 |
| 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 | 40 |
| Total | 78 |
Withdrawals & dropouts
| Period | Reason | FG000 | FG001 |
|---|---|---|---|
| Overall Study | Physician Decision | 3 | 1 |
| Overall Study | Protocol Violation | 3 | 7 |
| Overall Study | Withdrawal by Subject | 0 | 1 |
Baseline characteristics
| Characteristic | Total | Bupivacaine | Placebo |
|---|---|---|---|
| Age, Continuous | 0.84 years | 1 years | 0.8 years |
| Comorbidities Gastrointestinal | 2 Participants | 1 Participants | 1 Participants |
| Comorbidities Genetic | 18 Participants | 11 Participants | 7 Participants |
| Comorbidities Neurodevelopmental/Developmental Delay | 3 Participants | 1 Participants | 2 Participants |
| Comorbidities None | 49 Participants | 24 Participants | 25 Participants |
| Comorbidities Other | 3 Participants | 1 Participants | 2 Participants |
| Comorbidities Respiratory | 3 Participants | 0 Participants | 3 Participants |
| Race/Ethnicity, Customized American Indian/Alaskan | 4 Participants | 0 Participants | 4 Participants |
| Race/Ethnicity, Customized Asian | 1 Participants | 0 Participants | 1 Participants |
| Race/Ethnicity, Customized Bi-racial | 1 Participants | 0 Participants | 1 Participants |
| Race/Ethnicity, Customized Black/African American | 5 Participants | 3 Participants | 2 Participants |
| Race/Ethnicity, Customized Declined | 7 Participants | 3 Participants | 4 Participants |
| Race/Ethnicity, Customized Hispanic/Latino | 4 Participants | 2 Participants | 2 Participants |
| Race/Ethnicity, Customized White/Caucasian | 56 Participants | 30 Participants | 26 Participants |
| Region of Enrollment United States | 78 participants | 38 participants | 40 participants |
| Sex: Female, Male Female | 33 Participants | 15 Participants | 18 Participants |
| Sex: Female, Male Male | 45 Participants | 23 Participants | 22 Participants |
Adverse events
| Event type | EG000 affected / at risk | EG001 affected / at risk |
|---|---|---|
| deaths Total, all-cause mortality | 0 / 38 | 0 / 40 |
| other Total, other adverse events | 0 / 38 | 0 / 40 |
| serious Total, serious adverse events | 3 / 38 | 6 / 40 |
Outcome results
Primary
Patient-Controlled Analgesia (PCA) Fentanyl/Equivalent Day 0-1
Time frame: Day of Surgery and Postoperative Day 1
| Arm | Measure | Value (MEDIAN) |
|---|---|---|
| Bupivacaine | Patient-Controlled Analgesia (PCA) Fentanyl/Equivalent Day 0-1 | 15.7 mcg/kg/day |
| Placebo | Patient-Controlled Analgesia (PCA) Fentanyl/Equivalent Day 0-1 | 14.6 mcg/kg/day |
Primary
Total Fentanyl/Equivalent Day 0-1
Time frame: Day of Surgery and Postoperative Day 1
| Arm | Measure | Value (MEDIAN) |
|---|---|---|
| Bupivacaine | Total Fentanyl/Equivalent Day 0-1 | 23.6 mcg/kg/day |
| Placebo | Total Fentanyl/Equivalent Day 0-1 | 22.4 mcg/kg/day |
Secondary
Postoperative Cortisol Levels
Time frame: 12 hours post-surgery
| Arm | Measure | Value (MEDIAN) |
|---|---|---|
| Bupivacaine | Postoperative Cortisol Levels | 25.4 microgram/deciliter |
| Placebo | Postoperative Cortisol Levels | 27.7 microgram/deciliter |
Secondary
Postoperative Cortisol Levels
Time frame: 36 hours post-surgery
| Arm | Measure | Value (MEDIAN) |
|---|---|---|
| Bupivacaine | Postoperative Cortisol Levels | 9.4 microgram/deciliter |
| Placebo | Postoperative Cortisol Levels | 9.1 microgram/deciliter |
Secondary
Postoperative Length of Intubation
Time frame: 5 days post cardiac surgery
| Arm | Measure | Value (MEDIAN) |
|---|---|---|
| Bupivacaine | Postoperative Length of Intubation | 5.9 hours |
| Placebo | Postoperative Length of Intubation | 6.4 hours |
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).
Time frame: Day of Surgery
| Arm | Measure | Value (MEDIAN) |
|---|---|---|
| Bupivacaine | Postoperative Pain Scores-Face, Legs, Activity, Cry, Consolability (FLACC) Scale | 0 score on a scale |
| Placebo | Postoperative Pain Scores-Face, Legs, Activity, Cry, Consolability (FLACC) Scale | 0 score on a scale |
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).
Time frame: Day of Surgery
| Arm | Measure | Value (MEDIAN) |
|---|---|---|
| Bupivacaine | Postoperative Pain Scores-State Behavioral Scale (SBS) | -0.25 score on a scale |
| Placebo | Postoperative Pain Scores-State Behavioral Scale (SBS) | -0.25 score on a scale |