Clinical trial NCT04258436: Serratus Anterior Plane Block for Management of Post Thoracotomy Pain
Official title: Serratus Anterior Plane Block for Management of Post Thoracotomy Pain and Facilitation of Early Recovery After Pediatric Cardiac Surgery
Study type: INTERVENTIONAL
Overall status: TERMINATED
Phase: NA
Conditions: Opioid Use
Post-thoracotomy Pain Syndrome
Local Anaesthetic Agent Overdose
Local Anesthetic Complication
Pain, Postoperative
Keywords: Post thoractomy pain
Fascial plane blocks
Early recovery after thoractomy
Serratus anterior fascial block
Lead sponsor: Indiana University
Sponsor class: OTHER
First posted: 2020-02-06
Enrollment: 1
Sex: ALL
Minimum age (years): 38
Maximum age (years): 12
Standard ages: CHILD
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: OTHER

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.

Eligibility criteria: 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

Primary outcomes:
measure: Measurement of Postoperative Narcotic Exposure
timeFrame: From start of anesthesia to 24 hours postoperatively
Secondary outcomes:
measure: Duration of Mechanical Ventilation
timeFrame: From date and time of endotracheal intubation to the date and time of endotracheal extubation up to 100 days
measure: Length of Cardiovascular ICU stay
timeFrame: From admission to the Cardiovascular ICU until discharge ready time from the Cardiovascular ICU up to 100 days
measure: Postoperative Pain Scores
timeFrame: From arrival to ICU to 24 hours postoperatively
measure: Duration of Supplemental oxygen exposure
timeFrame: From date and time arriving in the ICU to date and time of discharge from hospital up to 100 days
measure: Adverse events
timeFrame: From block placement until 72 hours post operatively
Other outcomes:
Locations:
city: Indianapolis
country: United States
facility: Riley Hospital for Children
state: Indiana
Study officials:
affiliation: Indiana University Department of Anesthesia
name: Anne E Cossu, MD
role: PRINCIPAL_INVESTIGATOR
References: