Erector Spinae Plane Blockade in Pediatric Scoliosis Surgery Patients

Study Overview
=================
Brief Summary
-----------------
Providing effective analgesia after spinal fusion for idiopathic scoliosis remains a challenge with significant practice variation existing among high volume spine surgery centers. Even in the era of multimodal analgesia, opioids are the primary analgesics used for pain control after pediatric scoliosis surgery, but have multiple known adverse effects. The erector spinae plane block (ESPB) is a newly described fascial plane block performed by injecting local anesthetic between the erector spinae muscle and the transverse process. Additionally, there are case reports describing the ESPB as part of a multi-modal analgesic plan in adult degenerative spine surgery as well as adult spinal deformity surgery, demonstrating effective analgesia and no clinical motor blockade. Although it is known that the inflammatory reaction plays a crucial role in the mechanism of acute pain after major surgery, the effectiveness of the current regional approach on inflammatory response is not well studied.

Official Title
-----------------
Pediatric Scoliosis Surgery: Enhanced Recovery With Erector Spinae Plane Blockade Utilizing Surgically Placed Catheters

Conditions
-----------------
Scoliosis; Juvenile, Scoliosis; Adolescence

Intervention / Treatment
-----------------
* Procedure: Erector Spinae Plane Blockade


Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: ASA I-III Diagnosed with Idiopathic scoliosis Undergoing single-stage posterior spinal instrumentation and fusion Exclusion Criteria: Thorascopic tethering procedure Two-stage procedure Abnormal developmental profile Congenital/neuromuscular scoliosis Requiring PICU admission Known allergy to lidocaine Known cardiac, renal or liver disease or dysfunction Pre-existing pain complaints, i.e. on regular analgesic medications Current psychiatric diagnosis, e.g. anxiety, depression, eating disorder, defined according to DSM criteria. Requiring non-standard post-op pain management Any history of seizures Unplanned staged procedure Weight < 5th centile or > 85th centile for age Porphyria

Ages Eligible for Study
-----------------
Maximum Age: 18 Years

Sexes Eligible for Study
-----------------
All

Accepts Healthy Volunteers
-----------------
No

Study Plan
=================
How is the study designed?
-----------------

Design Details

Primary Purpose: Treatment
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Single


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: Erector Spinae Plane Blockade Treatment<br>Patients will receive an erector spinae plane blockade prior to their surgery as per standard regional anesthesia technique. | Procedure: Erector Spinae Plane Blockade<br>* The ESPB is fascial plane block performed by injecting local anesthetic between the erector spinae muscle and the transverse process. Its proposed mechanism of action is via blockade of the dorsal and ventral rami of the thoracic spinal nerves and sympathetic fibers.<br>|
| No Intervention: Erector Spinae Plane Blockade Control - Standard of Care<br>Patients will receive the standard of care for pediatric scoliosis surgery including multi-modal opioid pain management. If the patient declines to consent to enrollment into the randomized study, patients may still participate by allowing prospective data and samples collection/analysis with respect to perioperative choice. | |

What is the study measuring?
-----------------
Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Length of Stay (LOS) | Determine if bilateral surgical placed ESPBs will decrease length of stay in the pediatric ICU and the hospital. LOS and decrease postoperative opioid consumption.) | Through hospital stay, an average of 5 days | 
| Postoperative Opioid Consumption | Determine if bilateral surgical placed ESPBs will decrease postoperative opioid consumption measured in Morphine Milligram Equivalents (MME) | Through hospital stay, an average of 5 days | 
| Maximum lidocaine plasma concentration [Cmax] | Measure daily serial plasma lidocaine levels from ESPB catheters | Through hospital stay, an average of 5 days | 
| Patient-Reported Pain Scores | Patients will be asked on a daily basis by the research staff to report pain scores on a scale of 1-10 (1 signifying no pain to 10 signifying the worse pain). | Through hospital stay, an average of 5 days | 
| Inpatient Postoperative Mobility | Inpatient postoperative mobility will be tracked using activity tracker accelerometers and subsequently compared between the two groups. | Through hospital stay, an average of 5 days | 

 Terms related to the study
=================
Keywords Provided by Centre Hospitalier Valida
-----------------
Erector Spinae Plane Blockade, Pediatric Scoliosis