Pain, Postoperative Clinical Trial
Official title:
Continuous Erector Spinae Block Versus Continuous Paravertebral Block Following Thoracotomy: A Randomized, Controlled Non-Inferiority Study
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.
Status | Recruiting |
Enrollment | 100 |
Est. completion date | December 1, 2024 |
Est. primary completion date | December 1, 2024 |
Accepts healthy volunteers | Accepts Healthy Volunteers |
Gender | All |
Age group | 6 Months to 6 Years |
Eligibility | 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. |
Country | Name | City | State |
---|---|---|---|
United States | Boston Children"S Hospital | Boston | Massachusetts |
Lead Sponsor | Collaborator |
---|---|
Boston Children's Hospital |
United States,
Type | Measure | Description | Time frame | Safety issue |
---|---|---|---|---|
Primary | Rescue analgesic consumption | rescue opiates (rendered as morphine equivalents/kg) given by blinded providers using standard PCA/NCA demand protocols | 24 hours | |
Secondary | Pain scores | Pain scores measured by the numeric rating scale (NRS: 0/none -> 10/worst) | 24, 48 and 72 hours | |
Secondary | Time to perform the block in the operating room | Total time required for intervention | 1 hour | |
Secondary | Number of Adverse events | Any intervention related (or unrelated) adverse events | 1 week | |
Secondary | Rescue analgesic consumption | rescue opiates (rendered as morphine equivalents/kg) given by blinded providers using standard PCA/NCA demand protocols | 48 hours | |
Secondary | Rescue analgesic consumption | rescue opiates (rendered as morphine equivalents/kg) given by blinded providers using standard PCA/NCA demand protocols | 72 hours |
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