Back to resultsErector Spinae Plane Blocks for Adolescent Idiopathic Scoliosis
Primary Purpose
Pain, Postoperative, Opioid Use, Recruitment
Status
Enrolling by invitation
Phase
Not Applicable
Locations
United States
Study Type
Interventional
Intervention
Bilateral Erector Spinae Plane Block with bupivacaine and dexamethasone
No bilateral Erector Spinae Plane Block (no bupivacaine and no dexamethasone)
Sponsored by
About this trial
This is an interventional treatment trial for Pain, Postoperative
Eligibility Criteria
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
Sites / Locations
- Hospital for Special Surgery (HSS)
Arms of the Study
Arm 1
Arm 2
Arm Type
Active Comparator
Placebo Comparator
Arm Label
ESPB with Bupivacaine and Dexamethasone
No ESPB
Arm Description
12 pediatric spinal fusion surgery patients will be randomized to receive intraoperative ultrasound-guided bilateral ESPB with 0.25% bupivacaine with 2mg preservative free dexamethasone with a maximum of 30 mL total per side, depending on the patient's weight.
12 pediatric spinal fusion surgery patients will be randomized to not receive an intraoperative ultrasound-guided bilateral ESPB. These patients will still receive the standard anesthesia regimen during and after surgery.
Outcomes
Primary Outcome Measures
Number of patients who receive bilateral, pre-incision ESPB
Rate of adherence, number who enroll, number who receive the intervention and complete all assessments
Secondary Outcome Measures
Rate of Recruitment
Number screened/number enrolled
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.
Type and incidence of factors preventing performance of the block
Patient, surgical, anesthetic, and/or work flow related barriers
Attrition
Number of patients who enroll but do not receive the intervention and/or study assessments, and the reasons
Incidence of intra- and postoperative complications attributed to ESPB
Interference with intraoperative neuromonitoring, infection, local anesthetic toxicity, bleeding/hematoma, extremity weakness
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)
Total Opioid Consumption
Measured in mean oral morphine equivalents (OME)
Time to first opioid use
Time to pressing Intravenous Patient-Controlled Analgesia (IV PCA) and to requesting first oral opioid
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)
Patient/parent satisfaction with pain management
Measured via Likert rating scale (0 being strongly dissatisfied and 10 being strongly satisfied)
Full Information
NCT ID
NCT04500613
First Posted
July 27, 2020
Last Updated
February 9, 2023
Sponsor
Hospital for Special Surgery, New York
1. Study Identification
Unique Protocol Identification Number
NCT04500613
Brief Title
Erector Spinae Plane Blocks for Adolescent Idiopathic Scoliosis
Official Title
Utilization of Erector Spinae Plane Blocks in a Multimodal Analgesic Pathway for Instrumentation and Fusion of Adolescent Idiopathic Scoliosis: A Feasibility Study
Study Type
Interventional
2. Study Status
Record Verification Date
February 2023
Overall Recruitment Status
Enrolling by invitation
Study Start Date
February 22, 2021 (Actual)
Primary Completion Date
January 2024 (Anticipated)
Study Completion Date
January 2024 (Anticipated)
3. Sponsor/Collaborators
Responsible Party, by Official Title
Sponsor
Name of the Sponsor
Hospital for Special Surgery, New York
4. Oversight
Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
No
Product Manufactured in and Exported from the U.S.
No
Data Monitoring Committee
No
5. Study Description
Brief 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.
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Pain, Postoperative, Opioid Use, Recruitment
7. Study Design
Primary Purpose
Treatment
Study Phase
Not Applicable
Interventional Study Model
Parallel Assignment
Masking
ParticipantOutcomes Assessor
Allocation
Randomized
Enrollment
24 (Anticipated)
8. Arms, Groups, and Interventions
Arm Title
ESPB with Bupivacaine and Dexamethasone
Arm Type
Active Comparator
Arm Description
12 pediatric spinal fusion surgery patients will be randomized to receive intraoperative ultrasound-guided bilateral ESPB with 0.25% bupivacaine with 2mg preservative free dexamethasone with a maximum of 30 mL total per side, depending on the patient's weight.
Arm Title
No ESPB
Arm Type
Placebo Comparator
Arm Description
12 pediatric spinal fusion surgery patients will be randomized to not receive an intraoperative ultrasound-guided bilateral ESPB. These patients will still receive the standard anesthesia regimen during and after surgery.
Intervention Type
Procedure
Intervention Name(s)
Bilateral Erector Spinae Plane Block with bupivacaine and dexamethasone
Intervention Description
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.
Intervention Type
Other
Intervention Name(s)
No bilateral Erector Spinae Plane Block (no bupivacaine and no dexamethasone)
Intervention Description
Patients who are randomized to this group will not receive a bilateral erector spinae plane block
Primary Outcome Measure Information:
Title
Number of patients who receive bilateral, pre-incision ESPB
Description
Rate of adherence, number who enroll, number who receive the intervention and complete all assessments
Time Frame
through study completion, an average of 1 year
Secondary Outcome Measure Information:
Title
Rate of Recruitment
Description
Number screened/number enrolled
Time Frame
through study completion, an average of 1 year
Title
Blinding Assessment
Description
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.
Time Frame
24 hours after surgery
Title
Type and incidence of factors preventing performance of the block
Description
Patient, surgical, anesthetic, and/or work flow related barriers
Time Frame
Holding area, Post-Anesthesia Care Unit (PACU) (hour 0), hour 8, 12, and 24 hours after surgery
Title
Attrition
Description
Number of patients who enroll but do not receive the intervention and/or study assessments, and the reasons
Time Frame
through study completion, an average of 1 year
Title
Incidence of intra- and postoperative complications attributed to ESPB
Description
Interference with intraoperative neuromonitoring, infection, local anesthetic toxicity, bleeding/hematoma, extremity weakness
Time Frame
During surgery, PACU (hour 0), hour 8, 12, and 24 hours after surgery
Title
Pain Scores at Rest and Movement
Description
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)
Time Frame
PACU (hour 0), hour 8, 12, and 24 hours after surgery, and at hospital discharge (average 48 hours after surgery)
Title
Total Opioid Consumption
Description
Measured in mean oral morphine equivalents (OME)
Time Frame
0-24 hours after surgery (intraoperative, PACU, hours 8, 12, and 24 after surgery)
Title
Time to first opioid use
Description
Time to pressing Intravenous Patient-Controlled Analgesia (IV PCA) and to requesting first oral opioid
Time Frame
Up to 24 hours after surgery
Title
Opioid Related Side Effects
Description
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)
Time Frame
24 hours after surgery
Title
Patient/parent satisfaction with pain management
Description
Measured via Likert rating scale (0 being strongly dissatisfied and 10 being strongly satisfied)
Time Frame
At hospital discharge (average 48 hours after surgery)
10. Eligibility
Sex
All
Minimum Age & Unit of Time
10 Years
Maximum Age & Unit of Time
19 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
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
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Jordan Ruby, MD
Organizational Affiliation
Hospital for Special Surgery, New York
Official's Role
Principal Investigator
Facility Information:
Facility Name
Hospital for Special Surgery (HSS)
City
New York
State/Province
New York
ZIP/Postal Code
10021
Country
United States
12. IPD Sharing Statement
Plan to Share IPD
Yes
IPD Sharing Plan Description
Individual participant data that underlie the results will be shared, after deidentification (text, tables, figures, and appendices).
IPD Sharing Time Frame
Beginning 9 months and ending 36 months following article publication.
IPD Sharing Access Criteria
Data will be shared with investigators whose proposed use of the data has been approved by an independent review committee identified for this purpose.
Learn more about this trial
Erector Spinae Plane Blocks for Adolescent Idiopathic Scoliosis
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