Erector Spinae Plane Blockade in Pediatric Scoliosis Surgery Patients

Sponsor
Stanford University (Other)
Overall Status
Recruiting
CT.gov ID
NCT04153994
Collaborator
(none)
50
1
2
24.1
2.1

Study Details

Study Description

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.

Condition or Disease Intervention/Treatment Phase
  • Procedure: Erector Spinae Plane Blockade
N/A

Study Design

Study Type:
Interventional
Anticipated Enrollment :
50 participants
Allocation:
Randomized
Intervention Model:
Parallel Assignment
Masking:
Single (Outcomes Assessor)
Primary Purpose:
Treatment
Official Title:
Pediatric Scoliosis Surgery: Enhanced Recovery With Erector Spinae Plane Blockade Utilizing Surgically Placed Catheters
Actual Study Start Date :
Aug 28, 2020
Anticipated Primary Completion Date :
Sep 1, 2022
Anticipated Study Completion Date :
Sep 1, 2022

Arms and Interventions

Arm Intervention/Treatment
Experimental: Erector Spinae Plane Blockade Treatment

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

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.

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.

Outcome Measures

Primary Outcome Measures

  1. 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.)

  2. 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)

  3. Maximum lidocaine plasma concentration [Cmax] [Through hospital stay, an average of 5 days]

    Measure daily serial plasma lidocaine levels from ESPB catheters

  4. 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).

  5. 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.

Eligibility Criteria

Criteria

Ages Eligible for Study:
N/A to 18 Years
Sexes Eligible for Study:
All
Accepts 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

Contacts and Locations

Locations

Site City State Country Postal Code
1 Lucille Packard Children's Hospital Palo Alto California United States 94304

Sponsors and Collaborators

  • Stanford University

Investigators

None specified.

Study Documents (Full-Text)

None provided.

More Information

Publications

Responsible Party:
Chi-Ho Ban Tsui, Principal Investigator, Stanford University
ClinicalTrials.gov Identifier:
NCT04153994
Other Study ID Numbers:
  • 52852
First Posted:
Nov 6, 2019
Last Update Posted:
Aug 27, 2021
Last Verified:
Aug 1, 2021
Individual Participant Data (IPD) Sharing Statement:
No
Plan to Share IPD:
No
Studies a U.S. FDA-regulated Drug Product:
No
Studies a U.S. FDA-regulated Device Product:
No
Keywords provided by Chi-Ho Ban Tsui, Principal Investigator, Stanford University
Additional relevant MeSH terms:

Study Results

No Results Posted as of Aug 27, 2021