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Erector Spinae Plane Blockade in Pediatric Scoliosis Surgery Patients

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

Status
Recruiting
Phases
NA
Study type
Interventional
Source
ClinicalTrials.gov
Registry ID
NCT04153994
Enrollment
50
Registered
2019-11-06
Start date
2020-08-28
Completion date
2025-12-31
Last updated
2025-05-01

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Scoliosis; Adolescence, Scoliosis; Juvenile

Keywords

Erector Spinae Plane Blockade, Pediatric Scoliosis

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.

Interventions

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.

Sponsors

Stanford University
Lead SponsorOTHER

Study design

Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT
Masking
SINGLE (Outcomes Assessor)

Eligibility

Sex/Gender
ALL
Age
No minimum to 18 Years
Healthy volunteers
No

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

Design outcomes

Primary

MeasureTime frameDescription
Length of Stay (LOS)Through hospital stay, an average of 5 daysDetermine if bilateral surgical placed ESPBs will decrease length of stay in the pediatric ICU and the hospital. LOS and decrease postoperative opioid consumption.)
Postoperative Opioid ConsumptionThrough hospital stay, an average of 5 daysDetermine if bilateral surgical placed ESPBs will decrease postoperative opioid consumption measured in Morphine Milligram Equivalents (MME)
Maximum lidocaine plasma concentration [Cmax]Through hospital stay, an average of 5 daysMeasure daily serial plasma lidocaine levels from ESPB catheters
Patient-Reported Pain ScoresThrough hospital stay, an average of 5 daysPatients 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).
Inpatient Postoperative MobilityThrough hospital stay, an average of 5 daysInpatient postoperative mobility will be tracked using activity tracker accelerometers and subsequently compared between the two groups.

Countries

United States

Contacts

Primary ContactBan Tsui, MD
bantsui@stanford.edu(650)200-9107
Backup ContactChynna Villanueva, BS, RN
chynnav@stanford.edu6504986346

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Feb 4, 2026