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NCT Number: NCT04153994

Erector Spinae Plane Blockade in Pediatric Scoliosis Surgery Patients

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.

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Key information

Conditions

Scoliosis; Juvenile Bone Diseases Musculoskeletal Diseases Scoliosis Scoliosis; Adolescence Spinal Curvatures Spinal Diseases

Age range

Up to 18 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

Lucille Packard Children's Hospital

Palo Alto, California, 94304, United States

Location status: Recruiting

Location contact

Ban Tsui, MD

CONTACT

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

Erector Spinae Plane Blockade

Procedure

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.

Primary outcomes

  1. Length of Stay (LOS)

    Time frame: 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.)

  2. Postoperative Opioid Consumption

    Time frame: 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)

  3. Maximum lidocaine plasma concentration [Cmax]

    Time frame: Through hospital stay, an average of 5 days

    Measure daily serial plasma lidocaine levels from ESPB catheters

  4. Patient-Reported Pain Scores

    Time frame: 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).

  5. Inpatient Postoperative Mobility

    Time frame: 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.

Study contacts

Contact information is provided by the study sponsor or research team.

Ban Tsui, MD

CONTACT

[email protected]

(650)200-9107

Chynna Villanueva, BS, RN

CONTACT

[email protected]

6504986346

Sponsors and collaborators

Lead sponsor

Stanford University

Other

Registry information

Official study title

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

Important dates

Study start
2020
Primary completion
2025
Study completion
2025
First posted
Nov 6, 2019
Registry last updated
May 1, 2025

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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