Clinical trial
Continuous Erector Spinae Block Versus Continuous Paravertebral Block Following Thoracotomy: A Randomized, Controlled Non-Inferiority Study
Name
IRB-P00030317
Description
Overall Aim: To evaluate the efficacy of continuous erector spinae block (ESB) versus continuous paravertebral block (PVB) for postoperative analgesia in children and adolescents undergoing surgical procedures via unilateral thoracotomy.
Hypothesis: The investigators hypothesize that ESP block efficacy is not inferior to that of PVB with respect to pain control and consumed opiate equivalents at 24 hours postoperatively.
Trial arms
Trial start
2019-04-16
Estimated PCD
2024-12-01
Trial end
2024-12-01
Status
Recruiting
Phase
Early phase I
Treatment
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.
Arms:
continuous erector spinae block
Other names:
ESB with ropivacaine, Naropin
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.
Arms:
continuous paravertebral block
Other names:
PVB with ropivacaine, Naropin
Ropivacaine
Ropivacaine 0.2% will be the drug used for each group (ESB group and PVB group)
Arms:
continuous erector spinae block, continuous paravertebral block
Other names:
Naropin
Size
100
Primary endpoint
Rescue analgesic consumption
24 hours
Eligibility criteria
Inclusion Criteria:
* ASA I - III status, undergoing unilateral thoracotomy for either esophageal atresia related intrathoracic procedures or other non-cardiac general surgical intrathoracic procedures.
Exclusion Criteria:
* Patients undergoing procedures including pleurodesis, pleural stripping, and decortication or other procedures with widely distributed pleural disruption.
* Patients with severe neurodevelopmental delays.
* Patients with previous chronic pain syndromes.
* Patients with a history of opioid treatment at any point in the 2 months prior to surgery.
* Lack of parental consent and/or child assent.
Protocol
{'studyType': 'INTERVENTIONAL', 'phases': ['PHASE3'], 'designInfo': {'allocation': 'RANDOMIZED', 'interventionModel': 'PARALLEL', 'primaryPurpose': 'TREATMENT', 'maskingInfo': {'masking': 'TRIPLE', 'whoMasked': ['PARTICIPANT', 'CARE_PROVIDER', 'OUTCOMES_ASSESSOR']}}, 'enrollmentInfo': {'count': 100, 'type': 'ESTIMATED'}}
Updated at
2024-01-31
1 organization
1 product
2 indications
Organization
Boston Children's HospitalProduct
RopivacaineIndication
PainIndication
Postoperative