Pain, PostoperativeNCT04500613
Erector Spinae Plane Blocks for Adolescent Idiopathic Scoliosis
A study testing Bilateral Erector Spinae Plane Block with bupivacaine and dexamethasone and No bilateral Erector Spinae Plane Block (no bupivacaine and no dexamethasone) in people with Pain, Postoperative and Opioid Use, run by Hospital for Special Surgery, New York at 1 site in United States.
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). Read more about this study
- Who is it for?
- Ages 10 to 19 years
- Conditions the study is for
- Pain, Postoperative, Opioid Use, Recruitment
- What is being tested?
- Bilateral Erector Spinae Plane Block with bupivacaine and dexamethasone and No bilateral Erector Spinae Plane Block (no bupivacaine and no dexamethasone)
- Type of treatment
- Surgery or procedure
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 24 participants
- Where
- 1 siteUnited States
- Study dates
- 22 Feb 2021to 2 Dec 2022
- Phase
- Interventional
- Are there results?
- Yes, posted in the registrySummary in the doctors' view
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 10 to 19 years
- All sexes
- No healthy volunteers
- Child, Adult
Who may be able to join
- 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
Who cannot join
- 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
Trial locations and contacts
1 site in 1 country.
United States1 site
Hospital for Special Surgery (HSS)
New York, New York, 10021
About this study
Official title: Utilization of Erector Spinae Plane Blocks in a Multimodal Analgesic Pathway for Instrumentation and Fusion of Adolescent Idiopathic Scoliosis: A Feasibility Study
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.
- Conditions
- Pain, Postoperative, Opioid Use, Recruitment
- Being tested
- Bilateral Erector Spinae Plane Block with bupivacaine and dexamethasone, No bilateral Erector Spinae Plane Block (no bupivacaine and no dexamethasone)
- Medical subject headings
- Pain, Postoperative
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Bilateral Erector Spinae Plane Block with bupivacaine and dexamethasoneProcedure or surgery
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.
No bilateral Erector Spinae Plane Block (no bupivacaine and no dexamethasone)Other
Patients who are randomized to this group will not receive a bilateral erector spinae plane block
| Study group | Role | What they receive |
|---|---|---|
| ESPB with Bupivacaine and Dexamethasone | Active comparator | 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. Receives: Procedure: Bilateral Erector Spinae Plane Block with bupivacaine and dexamethasone |
| No ESPB | Placebo comparator | 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. Receives: Other: No bilateral Erector Spinae Plane Block (no bupivacaine and no dexamethasone) |
What is being measured
The primary outcome is the main question the study is designed to answer.
Number of Patients Who Receive Bilateral, Pre-incision ESPB
number who receive the intervention and complete all assessments
Measured: through study completion, an average of 1 year
Secondary outcomes (10)
Rate of Recruitment
Number enrolled and allocated to specific group
Measured: through study completion, an average of 1 year
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 or guessed the wrong group, respectively. This value is obtained by asking patients which group they believe they were randomly assigned to.
Measured: 24 hours after surgery
Number of Participants Unable to Receive ESPB Block.
Number of participants who were randomized to receive the ESPB block, but were unable to receive the block. The no ESPB group were randomized not to get the ESPB block, leading to 0 instances of missed ESPB block.
Measured: Holding area, Post-Anesthesia Care Unit (PACU) (hour 0), hour 8, 12, and 24 hours after surgery
Attrition
Number of patients who enroll but do not receive the intervention and/or study assessments.
Measured: through study completion, an average of 1 year
Incidence of Intra- and Postoperative Complications Attributed to ESPB
Interference with intraoperative neuromonitoring, infection, local anesthetic toxicity, bleeding/hematoma, extremity weakness
Measured: During surgery, PACU (hour 0), hour 8, 12, and 24 hours after surgery
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). NRS was collected for each participant, Mean and Standard Deviations are found below.
Measured: PACU (Post Anesthesia Care Unit, hour 0), hour 8, 12, and 24 hours after surgery, and at hospital discharge (an average of 4 days)
Total Opioid Consumption
Measured in mean oral morphine equivalents (OME)
Measured: 0-24 hours after surgery (OME within 24 hrs)
Time to First Opioid Use
Time to pressing Intravenous Patient-Controlled Analgesia (IV PCA) and to requesting first oral opioid
Measured: Up to 24 hours after surgery
Opioid Related Side Effects
Measured by 10 symptom Opioid Related Symptom Distress Scale (ORSDS). Frequency of each symptom within the cohort was assessed.
Measured: 24 hours after surgery
Patient/Parent Satisfaction With Pain Management
Measured via Likert rating scale (0 being strongly dissatisfied and 10 being strongly satisfied)
Measured: At hospital discharge (an average of 4 days)
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted5 Aug 2020
- Study start22 Feb 2021
- Primary completion28 Nov 2022
- Study completion2 Dec 2022
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Posted resultsParticipant flow, outcome measures and adverse events reported by the sponsor.
- Other trials for Pain, PostoperativeStudies of the same condition, open and under way.
- More trials run by Hospital for Special Surgery, New YorkThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Double blind
- Who is masked
- Participant, Outcomes assessor
- Enrolment
- 24 participants (actual)
Sponsor and investigators
- Lead sponsor
- Hospital for Special Surgery, New York
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
- Investigators
- Jordan Ruby, MD, Principal investigator, Hospital for Special Surgery, New York
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT04500613
- Sponsor's protocol ID
- 2019-2131
- Status last verified
- Nov 2024
- First submitted
- 27 Jul 2020
- Last updated
- 27 Dec 2024
- Results posted
- Yes, on ClinicalTrials.gov
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- Yes: Individual participant data that underlie the results will be shared, after deidentification (text, tables, figures, and appendices).
Study at a glance
From the registry record, last updated by the sponsor on 27 Dec 2024. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Utilization of Erector Spinae Plane Blocks in a Multimodal Analgesic Pathway for Instrumentation and Fusion of Adolescent Idiopathic Scoliosis: A Feasibility Study
- ClinicalTrials.gov ID
- NCT04500613
- Acronym / sponsor ID
- 2019-2131
- Conditions
- Pain, Postoperative, Opioid Use, Recruitment
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 24 participants (actual)
- Lead sponsor
- Hospital for Special Surgery, New YorkUniversity, hospital or other
- Study start
- 22 Feb 2021 (actual)
- Primary completion
- 28 Nov 2022 (actual)
- Study completion
- 2 Dec 2022 (actual)
- First posted
- 5 Aug 2020 (actual)
- Results
- Posted 2 Dec 2024
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Double blind (participant, outcomes assessor)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| ESPB with Bupivacaine and Dexamethasone | Active comparator | Procedure: Bilateral Erector Spinae Plane Block with bupivacaine and dexamethasone12 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. |
| No ESPB | Placebo comparator | Other: No bilateral Erector Spinae Plane Block (no bupivacaine and no dexamethasone)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. |
Who may qualify
- Ages
- 10 to 19 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Child, Adult
Key inclusion criteria (5 listed)
- 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
Key exclusion criteria (8 listed)
- 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)
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Bilateral Erector Spinae Plane Block with bupivacaine and dexamethasoneBupivacaine 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. | Procedure or surgery | ESPB with Bupivacaine and Dexamethasone |
| 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 | Other | No ESPB |
Primary outcome
Number of Patients Who Receive Bilateral, Pre-incision ESPB
Time frame: through study completion, an average of 1 year
number who receive the intervention and complete all assessments
10 secondary outcomes
Rate of Recruitment
Time frame: through study completion, an average of 1 year
Blinding Assessment
Time frame: 24 hours after surgery
Number of Participants Unable to Receive ESPB Block.
Time frame: Holding area, Post-Anesthesia Care Unit (PACU) (hour 0), hour 8, 12, and 24 hours after surgery
Attrition
Time frame: through study completion, an average of 1 year
Incidence of Intra- and Postoperative Complications Attributed to ESPB
Time frame: During surgery, PACU (hour 0), hour 8, 12, and 24 hours after surgery
Pain Scores at Rest and Movement
Time frame: PACU (Post Anesthesia Care Unit, hour 0), hour 8, 12, and 24 hours after surgery, and at hospital discharge (an average of 4 days)
Total Opioid Consumption
Time frame: 0-24 hours after surgery (OME within 24 hrs)
Time to First Opioid Use
Time frame: Up to 24 hours after surgery
Opioid Related Side Effects
Time frame: 24 hours after surgery
Patient/Parent Satisfaction With Pain Management
Time frame: At hospital discharge (an average of 4 days)
Results and safety
Loading the posted results from ClinicalTrials.gov…
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 27 Dec 2024.
- Posted resultsParticipant flow, baseline, all outcome measures and adverse events.
- Individual participant dataSharing planned: Yes. Individual participant data that underlie the results will be shared, after deidentification (text, tables, figures, and appendices).
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Jordan Ruby, MD principal investigator
Hospital for Special Surgery, New York
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Bilateral Erector Spinae Plane Block with bupivacaine and dexamethasone and No bilateral Erector Spinae Plane Block (no bupivacaine and no dexamethasone) in people with Pain, Postoperative and Opioid Use, run by Hospital for Special Surgery, New York at 1 site in United States.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 5 inclusion and 8 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 27 Dec 2024. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in United States. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. Some participants in this study may receive a placebo. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
Yes. Results are posted in the registry (first posted 2 Dec 2024). A summary is in the For doctors view, and the full results are on ClinicalTrials.gov.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Number of Patients Who Receive Bilateral, Pre-incision ESPB (time frame: through study completion, an average of 1 year). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 27 Dec 2024.