RECRUITING

Erector Spinae Plane Blockade in Pediatric Scoliosis Surgery Patients

Study Overview

This clinical trial focuses on testing the efficacy of different digital interventions to promote re-engagement in cancer-related long-term follow-up care for adolescent and young adult (AYA) survivors of childhood cancer.

Description

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

Quick Facts

Study Start:2020-08-28
Study Completion:2024-10
Study Type:Not specified
Phase:Not Applicable
Enrollment:Not specified
Status:RECRUITING

Study ID

NCT04153994

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Ages Eligible for Study:Not specified to 18 Years
Sexes Eligible for Study:ALL
Accepts Healthy Volunteers:No
Standard Ages:CHILD, ADULT
Inclusion CriteriaExclusion Criteria
  1. * ASA I-III
  2. * Diagnosed with Idiopathic scoliosis
  3. * Undergoing single-stage posterior spinal instrumentation and fusion
  1. * Thorascopic tethering procedure
  2. * Two-stage procedure
  3. * Abnormal developmental profile
  4. * Congenital/neuromuscular scoliosis
  5. * Requiring PICU admission
  6. * Known allergy to lidocaine
  7. * Known cardiac, renal or liver disease or dysfunction
  8. * Pre-existing pain complaints, i.e. on regular analgesic medications
  9. * Current psychiatric diagnosis, e.g. anxiety, depression, eating disorder, defined according to DSM criteria.
  10. * Requiring non-standard post-op pain management
  11. * Any history of seizures
  12. * Unplanned staged procedure
  13. * Weight \< 5th centile or \> 85th centile for age
  14. * Porphyria

Contacts and Locations

Study Contact

Ban Tsui, MD
CONTACT
(650)200-9107
bantsui@stanford.edu
Chynna Villanueva, BS, RN
CONTACT
6504986346
chynnav@stanford.edu

Study Locations (Sites)

Lucille Packard Children's Hospital
Palo Alto, California, 94304
United States

Collaborators and Investigators

Sponsor: Stanford University

Study Record Dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Registration Dates

Study Start Date2020-08-28
Study Completion Date2024-10

Study Record Updates

Study Start Date2020-08-28
Study Completion Date2024-10

Terms related to this study

Keywords Provided by Researchers

  • Erector Spinae Plane Blockade
  • Pediatric Scoliosis

Additional Relevant MeSH Terms

  • Scoliosis; Juvenile
  • Scoliosis; Adolescence