Erector Spinae Plane Blocks for Adolescent Idiopathic Scoliosis

Pain, Postoperative Clinical Trial

Official title:

Utilization of Erector Spinae Plane Blocks in a Multimodal Analgesic Pathway for Instrumentation and Fusion of Adolescent Idiopathic Scoliosis: A Feasibility Study

Clinical Trial Details — Status: Enrolling by invitation

Administrative data

• NCT number: NCT04500613
• Other study ID #: 2019-2131
• Status: Enrolling by invitation
• Phase: N/A
• Start date: February 22, 2021
• Est. completion date: January 2024

Study information

• Verified date: February 2023
• Source: Hospital for Special Surgery, New York
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial Summary

Pediatric spinal fusion (PSF) surgery is a painful procedure that can treat adolescent idiopathic scoliosis (AIS). One technique that can potentially reduce patients' pain levels and need for opioid medication is the ultrasound-guided Erector Spinae Plane Block (ESPB). The ESP block is a technique that involves injecting an anesthetic medication into the muscles of the lower back on both sides of the spine. Previous studies have shown that ESPB application led to a reduction in opioid use, and there is one pediatric case report of ESPB use in two patients undergoing PSF. However, there is still lack of evidence that the ESPB technique is feasible and effective in the pediatric patient population. The present study is designed to be the first randomized controlled trial to evaluate the role of ESPB in pediatric spinal fusion surgery and the role of ESPB within an enhanced recovery pathway.

Recruitment information / eligibility

• Status: Enrolling by invitation
• Enrollment: 24
• Est. completion date: January 2024
• Est. primary completion date: January 2024
• Accepts healthy volunteers: No
• Gender: All
• Age group: 10 Years to 19 Years

Eligibility

Inclusion Criteria:

• Age 10-19 years old
• Patients undergoing multilevel posterior spinal instrumentation and fusion
• Undergoing surgery for correction of adolescent idiopathic scoliosis
• Patients under the care of participating surgeons
• English Speaking

Exclusion Criteria:

• Patients younger than 10 years old or older than 19 years old
• Neuromuscular scoliosis
• Patient under the care of non-participating surgeon performing the procedure
• History of chronic opioid therapy (longer than 4 weeks) to treat back pain attributed to scoliosis tolerance, as defined by Centers for Disease Control (CDC) criteria (more than 60 oral morphine equivalents (OME) daily for over 2 weeks)
• Chronic pain conditions necessitating neuromodulating medications (gabapentin, pregabalin)
• Allergy, intolerance, or contraindication to any protocol component/study medication/technique
• Patient or parent refusal
• Non-english speaking

Related Conditions & MeSH terms

• Opioid Use
• Pain, Postoperative
• Recruitment
• Scoliosis

Intervention

Procedure:
• Bilateral Erector Spinae Plane Block with bupivacaine and dexamethasone
Bupivacaine is administered typically to reduce sensation in an area. It acts as a nerve block for surgical procedures. Dexamethasone is a corticosteroid that reduces inflammation.

Other:
• No bilateral Erector Spinae Plane Block (no bupivacaine and no dexamethasone)
Patients who are randomized to this group will not receive a bilateral erector spinae plane block

Locations

Country	Name	City	State
United States	Hospital for Special Surgery (HSS)	New York	New York

Sponsors (1)

Lead Sponsor	Collaborator
Hospital for Special Surgery, New York

Country where clinical trial is conducted

United States, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Number of patients who receive bilateral, pre-incision ESPB	Rate of adherence, number who enroll, number who receive the intervention and complete all assessments	through study completion, an average of 1 year
Secondary	Rate of Recruitment	Number screened/number enrolled	through study completion, an average of 1 year
Secondary	Blinding Assessment	Based on Bang's Blinding Index. Patients' ability to determine whether or not they received the ESPB. The success of patient blinding in each group will be quantified using the Bang Blinding Index which ranges from -1 to 1. Scores closest to 0 indicate a less likelihood that patients were able to guess which group they were randomized into. A score of 1 or -1 means that patients were able to guess which group they were in. This value is obtained by asking patients which group they believe they were randomly assigned to.	24 hours after surgery
Secondary	Type and incidence of factors preventing performance of the block	Patient, surgical, anesthetic, and/or work flow related barriers	Holding area, Post-Anesthesia Care Unit (PACU) (hour 0), hour 8, 12, and 24 hours after surgery
Secondary	Attrition	Number of patients who enroll but do not receive the intervention and/or study assessments, and the reasons	through study completion, an average of 1 year
Secondary	Incidence of intra- and postoperative complications attributed to ESPB	Interference with intraoperative neuromonitoring, infection, local anesthetic toxicity, bleeding/hematoma, extremity weakness	During surgery, PACU (hour 0), hour 8, 12, and 24 hours after surgery
Secondary	Pain Scores at Rest and Movement	Measured by Numeric Rating Scale (NRS) pain at rest and with movement (0 being no pain and 10 being as bad as you can imagine)	PACU (hour 0), hour 8, 12, and 24 hours after surgery, and at hospital discharge (average 48 hours after surgery)
Secondary	Total Opioid Consumption	Measured in mean oral morphine equivalents (OME)	0-24 hours after surgery (intraoperative, PACU, hours 8, 12, and 24 after surgery)
Secondary	Time to first opioid use	Time to pressing Intravenous Patient-Controlled Analgesia (IV PCA) and to requesting first oral opioid	Up to 24 hours after surgery
Secondary	Opioid Related Side Effects	Measured by 10 symptom Opioid Related Symptom Distress Scale (ORSDS) (symptom frequency: rarely to almost constantly; symptom severity: slight to very severe; symptom distress: not at all to very much)	24 hours after surgery
Secondary	Patient/parent satisfaction with pain management	Measured via Likert rating scale (0 being strongly dissatisfied and 10 being strongly satisfied)	At hospital discharge (average 48 hours after surgery)