Erector Spinae Plane Blockade in Pediatric Scoliosis Surgery Patients

Scoliosis; Adolescence Clinical Trial

Official title:

Pediatric Scoliosis Surgery: Enhanced Recovery With Erector Spinae Plane Blockade Utilizing Surgically Placed Catheters

Clinical Trial Details — Status: Recruiting

Administrative data

• NCT number: NCT04153994
• Other study ID #: 52852
• Status: Recruiting
• Phase: N/A
• Start date: August 28, 2020
• Est. completion date: October 2024

Study information

• Verified date: September 2023
• Source: Stanford University
• Contact: Ban Tsui, MD
• Phone: (650)200-9107
• Email: bantsui[@]stanford.edu
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

Recruitment information / eligibility

• Status: Recruiting
• Enrollment: 50
• Est. completion date: October 2024
• Est. primary completion date: October 2024
• Accepts healthy volunteers: No
• Gender: All
• Age group: N/A to 18 Years

Eligibility

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

Related Conditions & MeSH terms

• Scoliosis
• Scoliosis; Adolescence
• Scoliosis; Juvenile

Intervention

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.

Locations

Country	Name	City	State
United States	Lucille Packard Children's Hospital	Palo Alto	California

Sponsors (1)

Lead Sponsor	Collaborator
Stanford University

Country where clinical trial is conducted

United States, 

References & Publications (8)

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. — View 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. — View 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. — View 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. — View 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. — View 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. — View 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. — View 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. — View Citation

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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.)	Through hospital stay, an average of 5 days
Primary	Postoperative Opioid Consumption	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
Primary	Maximum lidocaine plasma concentration [Cmax]	Measure daily serial plasma lidocaine levels from ESPB catheters	Through hospital stay, an average of 5 days
Primary	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).	Through hospital stay, an average of 5 days
Primary	Inpatient Postoperative Mobility	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