- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT04153994
Erector Spinae Plane Blockade in Pediatric Scoliosis Surgery Patients
September 20, 2023 updated by: Chi-Ho Ban Tsui, Stanford University
Pediatric Scoliosis Surgery: Enhanced Recovery With Erector Spinae Plane Blockade Utilizing Surgically Placed Catheters
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.
Study Overview
Status
Recruiting
Conditions
Intervention / Treatment
Study Type
Interventional
Enrollment (Estimated)
50
Phase
- Not Applicable
Contacts and Locations
This section provides the contact details for those conducting the study, and information on where this study is being conducted.
Study Contact
- Name: Ban Tsui, MD
- Phone Number: (650)200-9107
- Email: bantsui@stanford.edu
Study Contact Backup
- Name: Chynna Villanueva, BS, RN
- Phone Number: 6504986346
- Email: chynnav@stanford.edu
Study Locations
-
-
California
-
Palo Alto, California, United States, 94304
- Recruiting
- Lucille Packard Children's Hospital
-
Contact:
- Ban Tsui, MD
-
-
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.
Eligibility Criteria
Ages Eligible for Study
No older than 18 years (Child, Adult)
Accepts Healthy Volunteers
No
Description
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
Study Plan
This section provides details of the study plan, including how the study is designed and what the study is measuring.
How is the study designed?
Design Details
- Primary Purpose: Treatment
- Allocation: Randomized
- Interventional Model: Parallel Assignment
- Masking: Single
Arms and Interventions
Participant Group / 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.
|
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.
|
What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
---|---|---|
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.)
|
Through hospital stay, an average of 5 days
|
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)
|
Through hospital stay, an average of 5 days
|
Maximum lidocaine plasma concentration [Cmax]
Time Frame: Through hospital stay, an average of 5 days
|
Measure daily serial plasma lidocaine levels from ESPB catheters
|
Through hospital stay, an average of 5 days
|
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).
|
Through hospital stay, an average of 5 days
|
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.
|
Through hospital stay, an average of 5 days
|
Collaborators and Investigators
This is where you will find people and organizations involved with this study.
Sponsor
Publications and helpful links
The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.
General Publications
- 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.
- 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.
- 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.
- 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.
- 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.
- 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.
- 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.
- 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.
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 Major Dates
Study Start (Actual)
August 28, 2020
Primary Completion (Estimated)
October 1, 2024
Study Completion (Estimated)
October 1, 2024
Study Registration Dates
First Submitted
October 24, 2019
First Submitted That Met QC Criteria
November 5, 2019
First Posted (Actual)
November 6, 2019
Study Record Updates
Last Update Posted (Actual)
September 22, 2023
Last Update Submitted That Met QC Criteria
September 20, 2023
Last Verified
September 1, 2023
More Information
Terms related to this study
Additional Relevant MeSH Terms
Other Study ID Numbers
- 52852
Plan for Individual participant data (IPD)
Plan to Share Individual Participant Data (IPD)?
NO
Drug and device information, study documents
Studies a U.S. FDA-regulated drug product
No
Studies a U.S. FDA-regulated device product
No
This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.
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