Opioid Use, Pain, Postoperative, Recruitment
Conditions
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.
Interventions
PROCEDUREBilateral 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.
OTHERNo 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
Sponsors
Hospital for Special Surgery, New York
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT
Masking
DOUBLE (Subject, Outcomes Assessor)
Eligibility
Sex/Gender
ALL
Age
10 Years to 19 Years
Healthy volunteers
No
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
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Number of Patients Who Receive Bilateral, Pre-incision ESPB | through study completion, an average of 1 year | number who receive the intervention and complete all assessments |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| Blinding Assessment | 24 hours after surgery | 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. |
| Number of Participants Unable to Receive ESPB Block. | Holding area, Post-Anesthesia Care Unit (PACU) (hour 0), hour 8, 12, and 24 hours after surgery | 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. |
| Attrition | through study completion, an average of 1 year | Number of patients who enroll but do not receive the intervention and/or study assessments. |
| Incidence of Intra- and Postoperative Complications Attributed to ESPB | During surgery, PACU (hour 0), hour 8, 12, and 24 hours after surgery | Interference with intraoperative neuromonitoring, infection, local anesthetic toxicity, bleeding/hematoma, extremity weakness |
| Rate of Recruitment | through study completion, an average of 1 year | Number enrolled and allocated to specific group |
| Total Opioid Consumption | 0-24 hours after surgery (OME within 24 hrs) | Measured in mean oral morphine equivalents (OME) |
| Time to First Opioid Use | Up to 24 hours after surgery | Time to pressing Intravenous Patient-Controlled Analgesia (IV PCA) and to requesting first oral opioid |
| Opioid Related Side Effects | 24 hours after surgery | Measured by 10 symptom Opioid Related Symptom Distress Scale (ORSDS). Frequency of each symptom within the cohort was assessed. |
| Patient/Parent Satisfaction With Pain Management | At hospital discharge (an average of 4 days) | Measured via Likert rating scale (0 being strongly dissatisfied and 10 being strongly satisfied) |
| Pain Scores at Rest and Movement | PACU (Post Anesthesia Care Unit, hour 0), hour 8, 12, and 24 hours after surgery, and at hospital discharge (an average of 4 days) | 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. |
Countries
United States
Participant flow
Participants by arm
| Arm | Count |
|---|---|
| ESPB With Bupivacaine and Dexamethasone 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.
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. | 11 |
| No ESPB 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.
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 | 12 |
| Total | 23 |
Baseline characteristics
| Characteristic | ESPB With Bupivacaine and Dexamethasone | Total | No ESPB |
|---|---|---|---|
| Age, Continuous | 14.6 years STANDARD_DEVIATION 2.1 | 14.9 years STANDARD_DEVIATION 2.1 | 15.1 years STANDARD_DEVIATION 2.3 |
| Ethnicity (NIH/OMB) Hispanic or Latino | 3 Participants | 5 Participants | 2 Participants |
| Ethnicity (NIH/OMB) Not Hispanic or Latino | 6 Participants | 15 Participants | 9 Participants |
| Ethnicity (NIH/OMB) Unknown or Not Reported | 2 Participants | 3 Participants | 1 Participants |
| Race (NIH/OMB) American Indian or Alaska Native | 0 Participants | 0 Participants | 0 Participants |
| Race (NIH/OMB) Asian | 0 Participants | 1 Participants | 1 Participants |
| Race (NIH/OMB) Black or African American | 3 Participants | 3 Participants | 0 Participants |
| Race (NIH/OMB) More than one race | 0 Participants | 0 Participants | 0 Participants |
| Race (NIH/OMB) Native Hawaiian or Other Pacific Islander | 0 Participants | 0 Participants | 0 Participants |
| Race (NIH/OMB) Unknown or Not Reported | 5 Participants | 9 Participants | 4 Participants |
| Race (NIH/OMB) White | 3 Participants | 10 Participants | 7 Participants |
| Region of Enrollment United States | 11 participants | 23 participants | 12 participants |
| Sex/Gender, Customized Gender Female | 6 Participants | 13 Participants | 7 Participants |
| Sex/Gender, Customized Gender Male | 4 Participants | 9 Participants | 5 Participants |
| Sex/Gender, Customized Gender Other | 1 Participants | 1 Participants | 0 Participants |
Adverse events
| Event type | EG000 affected / at risk | EG001 affected / at risk |
|---|---|---|
| deaths Total, all-cause mortality | 0 / 12 | 0 / 12 |
| other Total, other adverse events | 0 / 12 | 0 / 12 |
| serious Total, serious adverse events | 0 / 12 | 0 / 12 |
Outcome results
Primary
Number of Patients Who Receive Bilateral, Pre-incision ESPB
number who receive the intervention and complete all assessments
Time frame: through study completion, an average of 1 year
| Arm | Measure | Value (COUNT_OF_PARTICIPANTS) |
|---|---|---|
| ESPB With Bupivacaine and Dexamethasone | Number of Patients Who Receive Bilateral, Pre-incision ESPB | 9 Participants |
| No ESPB | Number of Patients Who Receive Bilateral, Pre-incision ESPB | 12 Participants |
Secondary
Attrition
Number of patients who enroll but do not receive the intervention and/or study assessments.
Time frame: through study completion, an average of 1 year
| Arm | Measure | Value (NUMBER) |
|---|---|---|
| ESPB With Bupivacaine and Dexamethasone | Attrition | 3 participants |
| No ESPB | Attrition | 0 participants |
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 or guessed the wrong group, respectively. This value is obtained by asking patients which group they believe they were randomly assigned to.
Time frame: 24 hours after surgery
| Arm | Measure | Value (MEAN) |
|---|---|---|
| ESPB With Bupivacaine and Dexamethasone | Blinding Assessment | 0 score on a scale |
| No ESPB | Blinding Assessment | -0.33 score on a scale |
Secondary
Incidence of Intra- and Postoperative Complications Attributed to ESPB
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
| Arm | Measure | Value (COUNT_OF_PARTICIPANTS) |
|---|---|---|
| ESPB With Bupivacaine and Dexamethasone | Incidence of Intra- and Postoperative Complications Attributed to ESPB | 0 Participants |
| No ESPB | Incidence of Intra- and Postoperative Complications Attributed to ESPB | 0 Participants |
Secondary
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.
Time frame: Holding area, Post-Anesthesia Care Unit (PACU) (hour 0), hour 8, 12, and 24 hours after surgery
| Arm | Measure | Value (COUNT_OF_PARTICIPANTS) |
|---|---|---|
| ESPB With Bupivacaine and Dexamethasone | Number of Participants Unable to Receive ESPB Block. | 2 Participants |
| No ESPB | Number of Participants Unable to Receive ESPB Block. | 0 Participants |
Secondary
Opioid Related Side Effects
Measured by 10 symptom Opioid Related Symptom Distress Scale (ORSDS). Frequency of each symptom within the cohort was assessed.
Time frame: 24 hours after surgery
| Arm | Measure | Group | Value (NUMBER) |
|---|---|---|---|
| ESPB With Bupivacaine and Dexamethasone | Opioid Related Side Effects | Constipation | 0 participants |
| ESPB With Bupivacaine and Dexamethasone | Opioid Related Side Effects | Fatigue | 3 participants |
| ESPB With Bupivacaine and Dexamethasone | Opioid Related Side Effects | Itching | 4 participants |
| ESPB With Bupivacaine and Dexamethasone | Opioid Related Side Effects | Concentration | 1 participants |
| ESPB With Bupivacaine and Dexamethasone | Opioid Related Side Effects | Urination | 0 participants |
| ESPB With Bupivacaine and Dexamethasone | Opioid Related Side Effects | Dizziness | 6 participants |
| ESPB With Bupivacaine and Dexamethasone | Opioid Related Side Effects | Confusion | 1 participants |
| ESPB With Bupivacaine and Dexamethasone | Opioid Related Side Effects | Nausea | 7 participants |
| ESPB With Bupivacaine and Dexamethasone | Opioid Related Side Effects | Vomiting | 3 participants |
| ESPB With Bupivacaine and Dexamethasone | Opioid Related Side Effects | Drowsiness | 6 participants |
| No ESPB | Opioid Related Side Effects | Vomiting | 5 participants |
| No ESPB | Opioid Related Side Effects | Fatigue | 9 participants |
| No ESPB | Opioid Related Side Effects | Drowsiness | 7 participants |
| No ESPB | Opioid Related Side Effects | Concentration | 2 participants |
| No ESPB | Opioid Related Side Effects | Dizziness | 8 participants |
| No ESPB | Opioid Related Side Effects | Constipation | 1 participants |
| No ESPB | Opioid Related Side Effects | Itching | 2 participants |
| No ESPB | Opioid Related Side Effects | Urination | 0 participants |
| No ESPB | Opioid Related Side Effects | Confusion | 2 participants |
| No ESPB | Opioid Related Side Effects | Nausea | 10 participants |
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). NRS was collected for each participant, Mean and Standard Deviations are found below.
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)
| Arm | Measure | Group | Value (MEAN) | Dispersion |
|---|---|---|---|---|
| ESPB With Bupivacaine and Dexamethasone | Pain Scores at Rest and Movement | NRS at 12 Hours | 3.3 score on a scale | Standard Deviation 2.45 |
| ESPB With Bupivacaine and Dexamethasone | Pain Scores at Rest and Movement | NRS with Movement at 24 Hours | 5.82 score on a scale | Standard Deviation 2.44 |
| ESPB With Bupivacaine and Dexamethasone | Pain Scores at Rest and Movement | NRS at 8 Hours | 4 score on a scale | Standard Deviation 3.37 |
| ESPB With Bupivacaine and Dexamethasone | Pain Scores at Rest and Movement | NRS at rest at Discharge | 3.36 score on a scale | Standard Deviation 1.5 |
| ESPB With Bupivacaine and Dexamethasone | Pain Scores at Rest and Movement | NRS at rest at 24 hours | 3.55 score on a scale | Standard Deviation 1.63 |
| ESPB With Bupivacaine and Dexamethasone | Pain Scores at Rest and Movement | NRS with movement at Discharge | 4.09 score on a scale | Standard Deviation 2.07 |
| ESPB With Bupivacaine and Dexamethasone | Pain Scores at Rest and Movement | NRS upon PACU Arrival | 3.64 score on a scale | Standard Deviation 3.93 |
| No ESPB | Pain Scores at Rest and Movement | NRS with movement at Discharge | 3.18 score on a scale | Standard Deviation 1.66 |
| No ESPB | Pain Scores at Rest and Movement | NRS upon PACU Arrival | 3.58 score on a scale | Standard Deviation 4.19 |
| No ESPB | Pain Scores at Rest and Movement | NRS at 8 Hours | 2.5 score on a scale | Standard Deviation 1.62 |
| No ESPB | Pain Scores at Rest and Movement | NRS at 12 Hours | 3 score on a scale | Standard Deviation 3.36 |
| No ESPB | Pain Scores at Rest and Movement | NRS at rest at 24 hours | 2.42 score on a scale | Standard Deviation 2.19 |
| No ESPB | Pain Scores at Rest and Movement | NRS with Movement at 24 Hours | 5 score on a scale | Standard Deviation 2.66 |
| No ESPB | Pain Scores at Rest and Movement | NRS at rest at Discharge | 3 score on a scale | Standard Deviation 1.95 |
Secondary
Patient/Parent Satisfaction With Pain Management
Measured via Likert rating scale (0 being strongly dissatisfied and 10 being strongly satisfied)
Time frame: At hospital discharge (an average of 4 days)
| Arm | Measure | Group | Value (MEDIAN) |
|---|---|---|---|
| ESPB With Bupivacaine and Dexamethasone | Patient/Parent Satisfaction With Pain Management | Patient | 10 score on a scale |
| ESPB With Bupivacaine and Dexamethasone | Patient/Parent Satisfaction With Pain Management | Parent | 10 score on a scale |
| No ESPB | Patient/Parent Satisfaction With Pain Management | Patient | 8 score on a scale |
| No ESPB | Patient/Parent Satisfaction With Pain Management | Parent | 9 score on a scale |
Secondary
Rate of Recruitment
Number enrolled and allocated to specific group
Time frame: through study completion, an average of 1 year
| Arm | Measure | Value (COUNT_OF_PARTICIPANTS) |
|---|---|---|
| ESPB With Bupivacaine and Dexamethasone | Rate of Recruitment | 12 Participants |
| No ESPB | Rate of Recruitment | 12 Participants |
Secondary
Time to First Opioid Use
Time to pressing Intravenous Patient-Controlled Analgesia (IV PCA) and to requesting first oral opioid
Time frame: Up to 24 hours after surgery
| Arm | Measure | Value (MEDIAN) |
|---|---|---|
| ESPB With Bupivacaine and Dexamethasone | Time to First Opioid Use | 178 minutes |
| No ESPB | Time to First Opioid Use | 94 minutes |
Secondary
Total Opioid Consumption
Measured in mean oral morphine equivalents (OME)
Time frame: 0-24 hours after surgery (OME within 24 hrs)
| Arm | Measure | Value (MEAN) | Dispersion |
|---|---|---|---|
| ESPB With Bupivacaine and Dexamethasone | Total Opioid Consumption | 78.23 milligrams | Standard Deviation 31.52 |
| No ESPB | Total Opioid Consumption | 53.89 milligrams | Standard Deviation 27.68 |