Erector Spinae Plane Blockade in Pediatric Scoliosis Surgery Patients

Not Applicable

Recruiting

• Conditions: Scoliosis; Adolescence; Scoliosis; Juvenile
• Interventions: Procedure: Erector Spinae Plane Blockade

• Registration Number: NCT04153994
• Lead Sponsor: Stanford University

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.

Detailed Description

Not available

Study Timeline

• Study First Submitted: 2019-10-24
• Study First Submitted QC: 2019-11-05
• Study First Posted: 2019-11-06
• Study Start: 2020-08-28
• Status Verified: 2023-09
• Last Update Submitted: 2023-09-20
• Last Update Posted: 2023-09-22
• Primary Completion: 2024-10
• Study Completion: 2024-10

Recruitment & Eligibility

• Status: RECRUITING
• Sex: All
• Target Recruitment: 50

Inclusion Criteria

• ASA I-III
• Diagnosed with Idiopathic scoliosis
• Undergoing single-stage posterior spinal instrumentation and fusion

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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

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Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
Erector Spinae Plane Blockade Treatment	Erector Spinae Plane Blockade	Patients will receive an erector spinae plane blockade prior to their surgery as per standard regional anesthesia technique.

Primary Outcome Measures

Name	Time	Method
Length of Stay (LOS)	Through hospital stay, an average of 5 days	Determine if bilateral surgical placed ESPBs will decrease length of stay in the pediatric ICU and the hospital. LOS and decrease postoperative opioid consumption.)
Maximum lidocaine plasma concentration [Cmax]	Through hospital stay, an average of 5 days	Measure daily serial plasma lidocaine levels from ESPB catheters
Patient-Reported Pain Scores	Through hospital stay, an average of 5 days	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).
Postoperative Opioid Consumption	Through hospital stay, an average of 5 days	Determine if bilateral surgical placed ESPBs will decrease postoperative opioid consumption measured in Morphine Milligram Equivalents (MME)
Inpatient Postoperative Mobility	Through hospital stay, an average of 5 days	Inpatient postoperative mobility will be tracked using activity tracker accelerometers and subsequently compared between the two groups.

Trial Locations

Locations (1)

Lucille Packard Children's Hospital; 🇺🇸 Palo Alto, California, United States