Clinical trial NCT04153994: 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
Overall status: RECRUITING
Phase: NA
Conditions: Scoliosis; Juvenile
Scoliosis; Adolescence
Keywords: Erector Spinae Plane Blockade
Pediatric Scoliosis
Lead sponsor: Stanford University
Sponsor class: OTHER
First posted: 2019-11-06
Enrollment: 50
Sex: ALL
Maximum age (years): 18
Standard ages: CHILD
ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

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.


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

Primary outcomes:
measure: Length of Stay (LOS)
timeFrame: Through hospital stay, an average of 5 days
measure: Postoperative Opioid Consumption
timeFrame: Through hospital stay, an average of 5 days
measure: Maximum lidocaine plasma concentration [Cmax]
timeFrame: Through hospital stay, an average of 5 days
measure: Patient-Reported Pain Scores
timeFrame: Through hospital stay, an average of 5 days
measure: Inpatient Postoperative Mobility
timeFrame: Through hospital stay, an average of 5 days
Secondary outcomes:
Other outcomes:
Locations:
city: Palo Alto
country: United States
facility: Lucille Packard Children's Hospital
state: California
Study officials:
References:
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.
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.
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.
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.
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.
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.
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.
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.