Opioid Use, Post-thoracotomy Pain Syndrome, Local Anaesthetic Agent Overdose, Local Anesthetic Complication, Pain, Postoperative
Conditions
Keywords
Post thoractomy pain, Fascial plane blocks, Early recovery after thoractomy, Serratus anterior fascial block
Brief summary
This is a single-center, randomized, prospective study evaluating the effect of serratus anterior plane block performed after induction of anesthesia, but before the start of surgery on postoperative opioid requirements. The hypothesis of the study is that serratus anterior plane blocks are relatively simple to perform, provide good postoperative analgesia, facilitate early tracheal extubation, and reduce the length of hospital stay after pediatric cardiac surgery through a thoracotomy.
Detailed description
This is a single-center, randomized, prospective study evaluating the effect of serratus anterior plane block performed after induction of anesthesia, but before the start of surgery on postoperative opioid requirements. There is already a postoperative protocol for the management of pain in the pediatric cardiac intensive care unit. This protocol will be maintained so all patients will be receiving clinically accepted and standard postoperative pain management. Routine preoperative evaluation will be performed to establish eligibility for study inclusion. All patients will receive anesthesia by a pediatric cardiac anesthesiologist according to the clinical protocol established for these patients. The serratus anterior plane block will be performed by a pediatric anesthesiologist on the acute pain service team who routinely perform pain blocks at this institution. Group 1 will receive an ultra-sound guided serratus anterior block after induction of general anesthesia. Group 2 will not receive a serratus anterior block. Postoperative pain will be managed by a pediatric cardiac intensivist according to a standard pain protocol.
Interventions
PROCEDURESerratus anterior block
Serratus anterior block will be performed using an ultrasound guided transducer to inject 2mg/kg of 0.2% ropivacaine
Sponsors
Indiana University
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
OTHER
Masking
SINGLE (Caregiver)
Masking description
Pediatric Cardiovascular ICU personnel will be blinded to the randomization assignment
Eligibility
Sex/Gender
ALL
Age
38 Weeks to 12 Months
Healthy volunteers
No
Inclusion criteria
* 12 months of age or less * Infants undergoing cardiac surgery through a thoracotomy incision * Infants having surgery performed by a Pediatric Cardiac Surgeon at Riley Hospital
Exclusion criteria
* Infants requiring sternotomy or emergency surgery * Allergy to local anesthetics * Neonates less that 37 weeks gestation * Infants intubated prior to surgery * Infection at the site of the Serratus Anterior Plane Block 6. Bleeding diathesis with increased risk of hematoma at the block site 7. Allergy to morphine 8. Active pulmonary infection
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Measurement of Postoperative Narcotic Exposure | From start of anesthesia to 24 hours postoperatively | Total morphine equivalents in first 24 hours |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| Duration of Mechanical Ventilation | From date and time of endotracheal intubation to the date and time of endotracheal extubation up to 100 days | Total Time in hours and minutes of endotracheal intubation from date and time of intubation to the date and time of extubation up to 100 days |
| Length of Cardiovascular ICU stay | From admission to the Cardiovascular ICU until discharge ready time from the Cardiovascular ICU up to 100 days | Duration of hospital stay in the Cardiovascular ICU in hours up to 100 days |
| Postoperative Pain Scores | From arrival to ICU to 24 hours postoperatively | Pain scores reported at arrival to ICU, and at 1, 2, 4, 6,8,10,12,and 24 hours |
| Duration of Supplemental oxygen exposure | From date and time arriving in the ICU to date and time of discharge from hospital up to 100 days | Total time of supplemental oxygen usage from date and time of endotracheal extubation and application of supplemental oxygen to date and time of supplemental oxygen discontinuation up to 100 days |
| Adverse events | From block placement until 72 hours post operatively | Complications from the block, anesthesia or the surgery up to 72 hours post operatively |
Countries
United States
Outcome results
None listed