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Erector Spinae Plane Blockade in Pediatric Scoliosis Surgery Patients

Primary Purpose

Scoliosis; Juvenile, Scoliosis; Adolescence

Status
Recruiting
Phase
Not Applicable
Locations
United States
Study Type
Interventional
Intervention
Erector Spinae Plane Blockade
Sponsored by
Stanford University
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Scoliosis; Juvenile focused on measuring Erector Spinae Plane Blockade, Pediatric Scoliosis

Eligibility Criteria

undefined - 18 Years (Child, Adult)All SexesDoes not accept healthy volunteers

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

Sites / Locations

  • Lucille Packard Children's HospitalRecruiting

Arms of the Study

Arm 1

Arm 2

Arm Type

Experimental

No Intervention

Arm Label

Erector Spinae Plane Blockade Treatment

Erector Spinae Plane Blockade Control - Standard of Care

Arm Description

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

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.

Outcomes

Primary Outcome Measures

Length of Stay (LOS)
Determine 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 Consumption
Determine if bilateral surgical placed ESPBs will decrease postoperative opioid consumption measured in Morphine Milligram Equivalents (MME)
Maximum lidocaine plasma concentration [Cmax]
Measure daily serial plasma lidocaine levels from ESPB catheters
Patient-Reported Pain Scores
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).
Inpatient Postoperative Mobility
Inpatient postoperative mobility will be tracked using activity tracker accelerometers and subsequently compared between the two groups.

Secondary Outcome Measures

Full Information

First Posted
October 24, 2019
Last Updated
September 20, 2023
Sponsor
Stanford University
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1. Study Identification

Unique Protocol Identification Number
NCT04153994
Brief Title
Erector Spinae Plane Blockade in Pediatric Scoliosis Surgery Patients
Official Title
Pediatric Scoliosis Surgery: Enhanced Recovery With Erector Spinae Plane Blockade Utilizing Surgically Placed Catheters
Study Type
Interventional

2. Study Status

Record Verification Date
September 2023
Overall Recruitment Status
Recruiting
Study Start Date
August 28, 2020 (Actual)
Primary Completion Date
October 2024 (Anticipated)
Study Completion Date
October 2024 (Anticipated)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Principal Investigator
Name of the Sponsor
Stanford University

4. Oversight

Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
No

5. 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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Scoliosis; Juvenile, Scoliosis; Adolescence
Keywords
Erector Spinae Plane Blockade, Pediatric Scoliosis

7. Study Design

Primary Purpose
Treatment
Study Phase
Not Applicable
Interventional Study Model
Parallel Assignment
Masking
Outcomes Assessor
Allocation
Randomized
Enrollment
50 (Anticipated)

8. Arms, Groups, and Interventions

Arm Title
Erector Spinae Plane Blockade Treatment
Arm Type
Experimental
Arm Description
Patients will receive an erector spinae plane blockade prior to their surgery as per standard regional anesthesia technique.
Arm Title
Erector Spinae Plane Blockade Control - Standard of Care
Arm Type
No Intervention
Arm Description
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.
Intervention Type
Procedure
Intervention Name(s)
Erector Spinae Plane Blockade
Intervention Description
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 Outcome Measure Information:
Title
Length of Stay (LOS)
Description
Determine if bilateral surgical placed ESPBs will decrease length of stay in the pediatric ICU and the hospital. LOS and decrease postoperative opioid consumption.)
Time Frame
Through hospital stay, an average of 5 days
Title
Postoperative Opioid Consumption
Description
Determine if bilateral surgical placed ESPBs will decrease postoperative opioid consumption measured in Morphine Milligram Equivalents (MME)
Time Frame
Through hospital stay, an average of 5 days
Title
Maximum lidocaine plasma concentration [Cmax]
Description
Measure daily serial plasma lidocaine levels from ESPB catheters
Time Frame
Through hospital stay, an average of 5 days
Title
Patient-Reported Pain Scores
Description
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).
Time Frame
Through hospital stay, an average of 5 days
Title
Inpatient Postoperative Mobility
Description
Inpatient postoperative mobility will be tracked using activity tracker accelerometers and subsequently compared between the two groups.
Time Frame
Through hospital stay, an average of 5 days

10. Eligibility

Sex
All
Maximum Age & Unit of Time
18 Years
Accepts Healthy Volunteers
No
Eligibility 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
Central Contact Person:
First Name & Middle Initial & Last Name or Official Title & Degree
Ban Tsui, MD
Phone
(650)200-9107
Email
bantsui@stanford.edu
First Name & Middle Initial & Last Name or Official Title & Degree
Chynna Villanueva, BS, RN
Phone
6504986346
Email
chynnav@stanford.edu
Facility Information:
Facility Name
Lucille Packard Children's Hospital
City
Palo Alto
State/Province
California
ZIP/Postal Code
94304
Country
United States
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Ban Tsui, MD

12. IPD Sharing Statement

Plan to Share IPD
No
Citations:
PubMed Identifier
14622770
Citation
Wheeler M, Oderda GM, Ashburn MA, Lipman AG. Adverse events associated with postoperative opioid analgesia: a systematic review. J Pain. 2002 Jun;3(3):159-80. doi: 10.1054/jpai.2002.123652. No abstract available.
Results Reference
background
PubMed Identifier
28870307
Citation
Sheffer BW, Kelly DM, Rhodes LN, Sawyer JR. Perioperative Pain Management in Pediatric Spine Surgery. Orthop Clin North Am. 2017 Oct;48(4):481-486. doi: 10.1016/j.ocl.2017.06.004. Epub 2017 Jul 15.
Results Reference
background
PubMed Identifier
27501016
Citation
Forero M, Adhikary SD, Lopez H, Tsui C, Chin KJ. The Erector Spinae Plane Block: A Novel Analgesic Technique in Thoracic Neuropathic Pain. Reg Anesth Pain Med. 2016 Sep-Oct;41(5):621-7. doi: 10.1097/AAP.0000000000000451.
Results Reference
background
PubMed Identifier
29649625
Citation
Kose HC, Kose SG, Thomas DT. Lumbar versus thoracic erector spinae plane block: Similar nomenclature, different mechanism of action. J Clin Anesth. 2018 Aug;48:1. doi: 10.1016/j.jclinane.2018.03.026. Epub 2018 Apr 9. No abstract available.
Results Reference
background
PubMed Identifier
30758122
Citation
Almeida CR, Oliveira AR, Cunha P. Continuous Bilateral Erector of Spine Plane Block at T8 for Extensive Lumbar Spine Fusion Surgery: Case Report. Pain Pract. 2019 Jun;19(5):536-540. doi: 10.1111/papr.12774. Epub 2019 Mar 15.
Results Reference
background
PubMed Identifier
30392347
Citation
Kline J, Chin KJ. Modified dual-injection lumbar erector spine plane (ESP) block for opioid-free anesthesia in multilevel lumbar laminectomy. Korean J Anesthesiol. 2019 Apr;72(2):188-190. doi: 10.4097/kja.d.18.00289. Epub 2018 Nov 2. No abstract available.
Results Reference
background
PubMed Identifier
29704223
Citation
Melvin JP, Schrot RJ, Chu GM, Chin KJ. Low thoracic erector spinae plane block for perioperative analgesia in lumbosacral spine surgery: a case series. Can J Anaesth. 2018 Sep;65(9):1057-1065. doi: 10.1007/s12630-018-1145-8. Epub 2018 Apr 27.
Results Reference
background
PubMed Identifier
19324125
Citation
Demmy TL, Nwogu C, Solan P, Yendamuri S, Wilding G, DeLeon O. Chest tube-delivered bupivacaine improves pain and decreases opioid use after thoracoscopy. Ann Thorac Surg. 2009 Apr;87(4):1040-6; discussion 1046-7. doi: 10.1016/j.athoracsur.2008.12.099.
Results Reference
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Erector Spinae Plane Blockade in Pediatric Scoliosis Surgery Patients

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