Trial Outcomes & Findings for Erector Spinae Plane Blocks for Adolescent Idiopathic Scoliosis (NCT NCT04500613)
NCT ID: NCT04500613
Last Updated: 2024-12-27
Results Overview
number who receive the intervention and complete all assessments
Recruitment status
COMPLETED
Study phase
NA
Target enrollment
24 participants
Primary outcome timeframe
through study completion, an average of 1 year
Results posted on
2024-12-27
Participant Flow
Participant milestones
| Measure |
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.
|
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
|
|---|---|---|
|
Overall Study
STARTED
|
12
|
12
|
|
Overall Study
COMPLETED
|
9
|
12
|
|
Overall Study
NOT COMPLETED
|
3
|
0
|
Reasons for withdrawal
Withdrawal data not reported
Baseline Characteristics
Erector Spinae Plane Blocks for Adolescent Idiopathic Scoliosis
Baseline characteristics by cohort
| Measure |
ESPB With Bupivacaine and Dexamethasone
n=11 Participants
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.
|
No ESPB
n=12 Participants
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
|
Total
n=23 Participants
Total of all reporting groups
|
|---|---|---|---|
|
Age, Continuous
|
14.6 years
STANDARD_DEVIATION 2.1 • n=5 Participants
|
15.1 years
STANDARD_DEVIATION 2.3 • n=7 Participants
|
14.9 years
STANDARD_DEVIATION 2.1 • n=5 Participants
|
|
Sex/Gender, Customized
Gender · Female
|
6 Participants
n=5 Participants
|
7 Participants
n=7 Participants
|
13 Participants
n=5 Participants
|
|
Sex/Gender, Customized
Gender · Male
|
4 Participants
n=5 Participants
|
5 Participants
n=7 Participants
|
9 Participants
n=5 Participants
|
|
Sex/Gender, Customized
Gender · Other
|
1 Participants
n=5 Participants
|
0 Participants
n=7 Participants
|
1 Participants
n=5 Participants
|
|
Ethnicity (NIH/OMB)
Hispanic or Latino
|
3 Participants
n=5 Participants
|
2 Participants
n=7 Participants
|
5 Participants
n=5 Participants
|
|
Ethnicity (NIH/OMB)
Not Hispanic or Latino
|
6 Participants
n=5 Participants
|
9 Participants
n=7 Participants
|
15 Participants
n=5 Participants
|
|
Ethnicity (NIH/OMB)
Unknown or Not Reported
|
2 Participants
n=5 Participants
|
1 Participants
n=7 Participants
|
3 Participants
n=5 Participants
|
|
Race (NIH/OMB)
American Indian or Alaska Native
|
0 Participants
n=5 Participants
|
0 Participants
n=7 Participants
|
0 Participants
n=5 Participants
|
|
Race (NIH/OMB)
Asian
|
0 Participants
n=5 Participants
|
1 Participants
n=7 Participants
|
1 Participants
n=5 Participants
|
|
Race (NIH/OMB)
Native Hawaiian or Other Pacific Islander
|
0 Participants
n=5 Participants
|
0 Participants
n=7 Participants
|
0 Participants
n=5 Participants
|
|
Race (NIH/OMB)
Black or African American
|
3 Participants
n=5 Participants
|
0 Participants
n=7 Participants
|
3 Participants
n=5 Participants
|
|
Race (NIH/OMB)
White
|
3 Participants
n=5 Participants
|
7 Participants
n=7 Participants
|
10 Participants
n=5 Participants
|
|
Race (NIH/OMB)
More than one race
|
0 Participants
n=5 Participants
|
0 Participants
n=7 Participants
|
0 Participants
n=5 Participants
|
|
Race (NIH/OMB)
Unknown or Not Reported
|
5 Participants
n=5 Participants
|
4 Participants
n=7 Participants
|
9 Participants
n=5 Participants
|
|
Region of Enrollment
United States
|
11 participants
n=5 Participants
|
12 participants
n=7 Participants
|
23 participants
n=5 Participants
|
PRIMARY outcome
Timeframe: through study completion, an average of 1 yearnumber who receive the intervention and complete all assessments
Outcome measures
| Measure |
ESPB With Bupivacaine and Dexamethasone
n=12 Participants
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.
|
No ESPB
n=12 Participants
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
|
|---|---|---|
|
Number of Patients Who Receive Bilateral, Pre-incision ESPB
|
9 Participants
|
12 Participants
|
SECONDARY outcome
Timeframe: through study completion, an average of 1 yearNumber enrolled and allocated to specific group
Outcome measures
| Measure |
ESPB With Bupivacaine and Dexamethasone
n=12 Participants
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.
|
No ESPB
n=12 Participants
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
|
|---|---|---|
|
Rate of Recruitment
|
12 Participants
|
12 Participants
|
SECONDARY outcome
Timeframe: 24 hours after surgeryBased 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.
Outcome measures
| Measure |
ESPB With Bupivacaine and Dexamethasone
n=11 Participants
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.
|
No ESPB
n=12 Participants
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
|
|---|---|---|
|
Blinding Assessment
|
0 score on a scale
Interval -0.3 to 0.3
|
-0.33 score on a scale
Interval -0.63 to -0.04
|
SECONDARY outcome
Timeframe: Holding area, Post-Anesthesia Care Unit (PACU) (hour 0), hour 8, 12, and 24 hours after surgeryNumber 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.
Outcome measures
| Measure |
ESPB With Bupivacaine and Dexamethasone
n=11 Participants
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.
|
No ESPB
n=12 Participants
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
|
|---|---|---|
|
Number of Participants Unable to Receive ESPB Block.
|
2 Participants
|
0 Participants
|
SECONDARY outcome
Timeframe: through study completion, an average of 1 yearNumber of patients who enroll but do not receive the intervention and/or study assessments.
Outcome measures
| Measure |
ESPB With Bupivacaine and Dexamethasone
n=12 Participants
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.
|
No ESPB
n=12 Participants
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
|
|---|---|---|
|
Attrition
|
3 participants
|
0 participants
|
SECONDARY outcome
Timeframe: During surgery, PACU (hour 0), hour 8, 12, and 24 hours after surgeryInterference with intraoperative neuromonitoring, infection, local anesthetic toxicity, bleeding/hematoma, extremity weakness
Outcome measures
| Measure |
ESPB With Bupivacaine and Dexamethasone
n=11 Participants
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.
|
No ESPB
n=12 Participants
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
|
|---|---|---|
|
Incidence of Intra- and Postoperative Complications Attributed to ESPB
|
0 Participants
|
0 Participants
|
SECONDARY outcome
Timeframe: 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.
Outcome measures
| Measure |
ESPB With Bupivacaine and Dexamethasone
n=11 Participants
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.
|
No ESPB
n=12 Participants
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
|
|---|---|---|
|
Pain Scores at Rest and Movement
NRS at 8 Hours
|
4 score on a scale
Standard Deviation 3.37
|
2.5 score on a scale
Standard Deviation 1.62
|
|
Pain Scores at Rest and Movement
NRS at 12 Hours
|
3.3 score on a scale
Standard Deviation 2.45
|
3 score on a scale
Standard Deviation 3.36
|
|
Pain Scores at Rest and Movement
NRS at rest at 24 hours
|
3.55 score on a scale
Standard Deviation 1.63
|
2.42 score on a scale
Standard Deviation 2.19
|
|
Pain Scores at Rest and Movement
NRS with Movement at 24 Hours
|
5.82 score on a scale
Standard Deviation 2.44
|
5 score on a scale
Standard Deviation 2.66
|
|
Pain Scores at Rest and Movement
NRS at rest at Discharge
|
3.36 score on a scale
Standard Deviation 1.5
|
3 score on a scale
Standard Deviation 1.95
|
|
Pain Scores at Rest and Movement
NRS with movement at Discharge
|
4.09 score on a scale
Standard Deviation 2.07
|
3.18 score on a scale
Standard Deviation 1.66
|
|
Pain Scores at Rest and Movement
NRS upon PACU Arrival
|
3.64 score on a scale
Standard Deviation 3.93
|
3.58 score on a scale
Standard Deviation 4.19
|
SECONDARY outcome
Timeframe: 0-24 hours after surgery (OME within 24 hrs)Measured in mean oral morphine equivalents (OME)
Outcome measures
| Measure |
ESPB With Bupivacaine and Dexamethasone
n=11 Participants
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.
|
No ESPB
n=12 Participants
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
|
|---|---|---|
|
Total Opioid Consumption
|
78.23 milligrams
Standard Deviation 31.52
|
53.89 milligrams
Standard Deviation 27.68
|
SECONDARY outcome
Timeframe: Up to 24 hours after surgeryTime to pressing Intravenous Patient-Controlled Analgesia (IV PCA) and to requesting first oral opioid
Outcome measures
| Measure |
ESPB With Bupivacaine and Dexamethasone
n=11 Participants
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.
|
No ESPB
n=12 Participants
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
|
|---|---|---|
|
Time to First Opioid Use
|
178 minutes
Interval 43.0 to 309.0
|
94 minutes
Interval 57.5 to 246.5
|
SECONDARY outcome
Timeframe: 24 hours after surgeryMeasured by 10 symptom Opioid Related Symptom Distress Scale (ORSDS). Frequency of each symptom within the cohort was assessed.
Outcome measures
| Measure |
ESPB With Bupivacaine and Dexamethasone
n=11 Participants
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.
|
No ESPB
n=12 Participants
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
|
|---|---|---|
|
Opioid Related Side Effects
Fatigue
|
3 participants
|
9 participants
|
|
Opioid Related Side Effects
Drowsiness
|
6 participants
|
7 participants
|
|
Opioid Related Side Effects
Concentration
|
1 participants
|
2 participants
|
|
Opioid Related Side Effects
Nausea
|
7 participants
|
10 participants
|
|
Opioid Related Side Effects
Dizziness
|
6 participants
|
8 participants
|
|
Opioid Related Side Effects
Constipation
|
0 participants
|
1 participants
|
|
Opioid Related Side Effects
Itching
|
4 participants
|
2 participants
|
|
Opioid Related Side Effects
Urination
|
0 participants
|
0 participants
|
|
Opioid Related Side Effects
Confusion
|
1 participants
|
2 participants
|
|
Opioid Related Side Effects
Vomiting
|
3 participants
|
5 participants
|
SECONDARY outcome
Timeframe: At hospital discharge (an average of 4 days)Measured via Likert rating scale (0 being strongly dissatisfied and 10 being strongly satisfied)
Outcome measures
| Measure |
ESPB With Bupivacaine and Dexamethasone
n=11 Participants
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.
|
No ESPB
n=10 Participants
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
|
|---|---|---|
|
Patient/Parent Satisfaction With Pain Management
Patient
|
10 score on a scale
Interval 7.0 to 10.0
|
8 score on a scale
Interval 7.0 to 10.0
|
|
Patient/Parent Satisfaction With Pain Management
Parent
|
10 score on a scale
Interval 9.0 to 10.0
|
9 score on a scale
Interval 8.0 to 10.0
|
Adverse Events
ESPB With Bupivacaine and Dexamethasone
Serious events: 0 serious events
Other events: 0 other events
Deaths: 0 deaths
No ESPB
Serious events: 0 serious events
Other events: 0 other events
Deaths: 0 deaths
Serious adverse events
Adverse event data not reported
Other adverse events
Adverse event data not reported
Additional Information
Results disclosure agreements
- Principal investigator is a sponsor employee
- Publication restrictions are in place