Trial Outcomes & Findings for Continuous Erector Spinae Block Versus Continuous Paravertebral Block (NCT NCT03768440)
NCT ID: NCT03768440
Last Updated: 2026-05-13
Results Overview
rescue opiates (rendered as morphine equivalents/kg) given by blinded providers using standard PCA/NCA demand protocols
TERMINATED
PHASE3
34 participants
24 hours
2026-05-13
Participant Flow
Participant milestones
| Measure |
Continuous Erector Spinae Block
An erector spinae block is placed at end of the thoracotomy procedure, bolused with 1ml/kg 0.2% ropivacaine, then started on a 0.2ml/kg/hour continuous infusion of 0.2% ropivacaine. patients will have access to rescue opiates as needed by means of the standard PCA/NCA demand protocols utilized at BCH. Rescue analgesic consumption will be tabulated at 24, 48 and 72 hours, rendered as total opiate equivalents.
continuous erector spinae block (ESB): Erector spinae block: T4/5 transverse process is identified with the ultrasound transducer in a parasagittal orientation; the needle tip is advanced until it contacts the transverse process, just below the erector spinae muscle complex; the erector spinae muscle is visualized to be elevated up off of the transverse process with normal saline injection. Following a bolus injection of 2ml/kg of 0.2% ropivacaine, a catheter is threaded into the space occupied by the local anesthetic bolus.
Ropivacaine: Ropivacaine 0.2% will be the drug used for each group (ESB group and PVB group)
|
Continuous Paravertebral Block
A paravertebral block is placed at end of the thoracotomy procedure, bolused with 1ml/kg 0.2% ropivacaine, then started on a 0.2ml/kg/hour continuous infusion of 0.2% ropivacaine. patients will have access to rescue opiates as needed by means of the standard PCA/NCA demand protocols utilized at BCH. Rescue analgesic consumption will be tabulated at 24, 48 and 72 hours, rendered as total opiate equivalents.
continuous paravertebral block (PVB): The paravertebral space (bound medially by the bodies of the vertebrae, intervertebral discs, and intervertebral foraminae; anterolaterally by the parietal pleura and the innermost intercostal membrane; posteriorly by the transverse processes of the thoracic vertebrae, heads of the ribs, and the superior costotransverse ligament) laying between T4/5 is identified using the ultrasound transducer in a transverse orientation; the needle tip is advanced until it is seen passing under the transverse process, immediately superior to the pleura; the pleura is seen to deflect downward with normal saline injection. Following a bolus injection of 2ml/kg of 0.2% ropivacaine, a catheter is threaded into the space occupied by the local anesthetic bolus.
Ropivacaine: Ropivacaine 0.2% will be the drug used for each group (ESB group and PVB group)
|
|---|---|---|
|
Overall Study
STARTED
|
16
|
18
|
|
Overall Study
COMPLETED
|
12
|
12
|
|
Overall Study
NOT COMPLETED
|
4
|
6
|
Reasons for withdrawal
| Measure |
Continuous Erector Spinae Block
An erector spinae block is placed at end of the thoracotomy procedure, bolused with 1ml/kg 0.2% ropivacaine, then started on a 0.2ml/kg/hour continuous infusion of 0.2% ropivacaine. patients will have access to rescue opiates as needed by means of the standard PCA/NCA demand protocols utilized at BCH. Rescue analgesic consumption will be tabulated at 24, 48 and 72 hours, rendered as total opiate equivalents.
continuous erector spinae block (ESB): Erector spinae block: T4/5 transverse process is identified with the ultrasound transducer in a parasagittal orientation; the needle tip is advanced until it contacts the transverse process, just below the erector spinae muscle complex; the erector spinae muscle is visualized to be elevated up off of the transverse process with normal saline injection. Following a bolus injection of 2ml/kg of 0.2% ropivacaine, a catheter is threaded into the space occupied by the local anesthetic bolus.
Ropivacaine: Ropivacaine 0.2% will be the drug used for each group (ESB group and PVB group)
|
Continuous Paravertebral Block
A paravertebral block is placed at end of the thoracotomy procedure, bolused with 1ml/kg 0.2% ropivacaine, then started on a 0.2ml/kg/hour continuous infusion of 0.2% ropivacaine. patients will have access to rescue opiates as needed by means of the standard PCA/NCA demand protocols utilized at BCH. Rescue analgesic consumption will be tabulated at 24, 48 and 72 hours, rendered as total opiate equivalents.
continuous paravertebral block (PVB): The paravertebral space (bound medially by the bodies of the vertebrae, intervertebral discs, and intervertebral foraminae; anterolaterally by the parietal pleura and the innermost intercostal membrane; posteriorly by the transverse processes of the thoracic vertebrae, heads of the ribs, and the superior costotransverse ligament) laying between T4/5 is identified using the ultrasound transducer in a transverse orientation; the needle tip is advanced until it is seen passing under the transverse process, immediately superior to the pleura; the pleura is seen to deflect downward with normal saline injection. Following a bolus injection of 2ml/kg of 0.2% ropivacaine, a catheter is threaded into the space occupied by the local anesthetic bolus.
Ropivacaine: Ropivacaine 0.2% will be the drug used for each group (ESB group and PVB group)
|
|---|---|---|
|
Overall Study
Physician Decision
|
4
|
6
|
Baseline Characteristics
Race and Ethnicity were not collected from any participant.
Baseline characteristics by cohort
| Measure |
Continuous Erector Spinae Block
n=16 Participants
An erector spinae block is placed at end of the thoracotomy procedure, bolused with 1ml/kg 0.2% ropivacaine, then started on a 0.2ml/kg/hour continuous infusion of 0.2% ropivacaine. patients will have access to rescue opiates as needed by means of the standard PCA/NCA demand protocols utilized at BCH. Rescue analgesic consumption will be tabulated at 24, 48 and 72 hours, rendered as total opiate equivalents.
continuous erector spinae block (ESB): Erector spinae block: T4/5 transverse process is identified with the ultrasound transducer in a parasagittal orientation; the needle tip is advanced until it contacts the transverse process, just below the erector spinae muscle complex; the erector spinae muscle is visualized to be elevated up off of the transverse process with normal saline injection. Following a bolus injection of 2ml/kg of 0.2% ropivacaine, a catheter is threaded into the space occupied by the local anesthetic bolus.
Ropivacaine: Ropivacaine 0.2% will be the drug used for each group (ESB group and PVB group)
|
Continuous Paravertebral Block
n=18 Participants
A paravertebral block is placed at end of the thoracotomy procedure, bolused with 1ml/kg 0.2% ropivacaine, then started on a 0.2ml/kg/hour continuous infusion of 0.2% ropivacaine. patients will have access to rescue opiates as needed by means of the standard PCA/NCA demand protocols utilized at BCH. Rescue analgesic consumption will be tabulated at 24, 48 and 72 hours, rendered as total opiate equivalents.
continuous paravertebral block (PVB): The paravertebral space (bound medially by the bodies of the vertebrae, intervertebral discs, and intervertebral foraminae; anterolaterally by the parietal pleura and the innermost intercostal membrane; posteriorly by the transverse processes of the thoracic vertebrae, heads of the ribs, and the superior costotransverse ligament) laying between T4/5 is identified using the ultrasound transducer in a transverse orientation; the needle tip is advanced until it is seen passing under the transverse process, immediately superior to the pleura; the pleura is seen to deflect downward with normal saline injection. Following a bolus injection of 2ml/kg of 0.2% ropivacaine, a catheter is threaded into the space occupied by the local anesthetic bolus.
Ropivacaine: Ropivacaine 0.2% will be the drug used for each group (ESB group and PVB group)
|
Total
n=34 Participants
Total of all reporting groups
|
|---|---|---|---|
|
Age, Continuous
|
3.25 years
n=16 Participants
|
2.5 years
n=18 Participants
|
2.88 years
n=34 Participants
|
|
Sex: Female, Male
Female
|
3 Participants
n=16 Participants
|
6 Participants
n=18 Participants
|
9 Participants
n=34 Participants
|
|
Sex: Female, Male
Male
|
13 Participants
n=16 Participants
|
12 Participants
n=18 Participants
|
25 Participants
n=34 Participants
|
|
Race and Ethnicity Not Collected
|
—
|
—
|
0 Participants
Race and Ethnicity were not collected from any participant.
|
PRIMARY outcome
Timeframe: 24 hoursPopulation: This protocol was closed because recruitment became infeasible after the primary surgical team and patient population moved to an unaffiliated hospital. Remaining patients were ineligible due to changes in surgical technique. No opioid or other outcome data were ever queried or collected for analysis; therefore, no results were generated or analyzed.
rescue opiates (rendered as morphine equivalents/kg) given by blinded providers using standard PCA/NCA demand protocols
Outcome measures
Outcome data not reported
Adverse Events
Continuous Erector Spinae Block
Continuous Paravertebral Block
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