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Erector Spinae Plane Blockade in Pediatric Scoliosis Surgery Patients

Study Purpose

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.

Recruitment Criteria

Accepts Healthy Volunteers

Healthy volunteers are participants who do not have a disease or condition, or related conditions or symptoms

 No
Study Type

An interventional clinical study is where participants are assigned to receive one or more interventions (or no intervention) so that researchers can evaluate the effects of the interventions on biomedical or health-related outcomes.


An observational clinical study is where participants identified as belonging to study groups are assessed for biomedical or health outcomes.


Searching Both is inclusive of interventional and observational studies.

 Interventional
Eligible Ages N/A - 18 Years
Gender All
More Inclusion & Exclusion 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

Trial Details

Trial ID:

This trial id was obtained from ClinicalTrials.gov, a service of the U.S. National Institutes of Health, providing information on publicly and privately supported clinical studies of human participants with locations in all 50 States and in 196 countries.

 NCT04153994
Phase

Phase 1: Studies that emphasize safety and how the drug is metabolized and excreted in humans.

Phase 2: Studies that gather preliminary data on effectiveness (whether the drug works in people who have a certain disease or condition) and additional safety data.

Phase 3: Studies that gather more information about safety and effectiveness by studying different populations and different dosages and by using the drug in combination with other drugs.

Phase 4: Studies occurring after FDA has approved a drug for marketing, efficacy, or optimal use.

 N/A
Lead Sponsor

The sponsor is the organization or person who oversees the clinical study and is responsible for analyzing the study data.

 Stanford University
Principal Investigator

The person who is responsible for the scientific and technical direction of the entire clinical study.

 N/A
Principal Investigator Affiliation N/A
Agency Class

Category of organization(s) involved as sponsor (and collaborator) supporting the trial.

 Other
Overall Status Recruiting
Countries United States
Conditions

The disease, disorder, syndrome, illness, or injury that is being studied.

 Scoliosis; Juvenile, Scoliosis; Adolescence
Arms & Interventions

Arms

Experimental: Erector Spinae Plane Blockade Treatment

Patients will receive an erector spinae plane blockade prior to their surgery as per standard regional anesthesia technique.

No Intervention: Erector Spinae Plane Blockade Control - Standard of Care

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.

Interventions

Procedure: - Erector Spinae Plane Blockade

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.

Contact a Trial Team

If you are interested in learning more about this trial, find the trial site nearest to your location and contact the site coordinator via email or phone. We also strongly recommend that you consult with your healthcare provider about the trials that may interest you and refer to our terms of service below.

Lucille Packard Children's Hospital, Palo Alto, California

Status

Recruiting

Address

Lucille Packard Children's Hospital

Palo Alto, California, 94304

Site Contact

Ban Tsui, MD

[email protected]

(650)200-9107

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