An interventional study of Ropivacaine and erector spinae plane block in Cystic Adenomatoid Malformation of Lung, Congenital, Bronchopulmonary Sequestration and Bronchogenic Cyst, sponsored by Lei Xiaoming. Completed at 1 site in China. Open to participants aged 1 Month to 12 Months. Per ClinicalTrials.gov, last updated 2026-04-22.
Sponsored by Lei Xiaoming · Not applicable, Interventional, and Treatment
This study intends to evaluate the effect of erector spinae plane block on postoperative analgesia and sleep quality in infants with congenital cystic pulmonary disease after thoracoscopic surgery, and provides reference for perioperative pain treatment in children.
Severe pain may occur after pediatric thoracic surgery, such as skin incision, rib traction, drainage tube placement, or intercostal nerve dysfunction caused by suture. Pain may cause weakened coughing power to clear secretions, decreased functional residual capacity, leading to pulmonary complications such as atelectasis and pneumonia, and postoperative acute pain develops into chronic pain. It has been reported that postoperative sleep disorders are associated with increased pain scores, which are very unfavorable for postoperative rehabilitation of pediatric patients. In clinical practice, because infants cannot accurately describe pain, their postoperative pain management may not be sufficient and has not received enough attention. But, some studies have shown that infants may feel more severe pain than adults, and the pain has a more obvious and lasting effect on infants and young children than on adults.
Congenital pulmonary cystic disease is a rare congenital pulmonary developmental abnormality in clinic. It can't heal itself and is easy to cause various complications. Once diagnosed, surgical treatment should be considered immediately.
In the past experience, thoracic epidural block and thoracic paravertebral nerve block are commonly used for postoperative analgesia in thoracic surgery, but they have taboos such as abnormal coagulation function, high technical requirements and potential risks of serious complications.
Since the erector spinae plane block (ESPB) was first reported and successfully implemented in 2016, because it is far away from the neural axis, major vascular structures, pleura and other structures, with a lower possibility of complications, simpler operation and higher safety, it has been widely used in perioperative analgesia and acute and chronic pain in cardiothoracic surgery, breast surgery, abdominal surgery, spinal surgery, etc. However, the reports on pediatric patients are still mainly case reports, and there is a lack of large-sample randomized controlled clinical trials. Therefore, this study intends to perform erector spinae plane block under ultrasound guidance to observe the effect on postoperative analgesia and sleep quality in pediatric thoracoscopic surgery.
This is the only study on the registry with Lei Xiaoming as lead sponsor.
Counted across the registry records on this site, refreshed daily.
Exclusion Criteria:
Drug: Ropivacaine · Procedure: erector spinae plane block
Drug: Ropivacaine · Procedure: Incision infiltration of local anesthesia
0.25 % ropivacaine ( 0.5ml / kg )
After the operation, unilateral erector spinae plane block was performed at the T5 level under ultrasound guidance.
After the operation, Incision infiltration of local anesthesia is performed around the surgical incisions.
postoperative FLACC score
Time frame: 2, 4, 6, 12, 24, 48 hours after operation
Postoperative sleep quality score
The Pittsburgh Sleep Quality Index was used to evaluate the sleep quality of children 7 days after surgery.
Time frame: 1, 2, 3, 4, 5, 6, 7 days after operation
Number of participants with emergence agitation as assessed by PAED
The Pediatric Anesthesia Emergence Delirium (PAED) was used to evaluate emergence agitation after extubation in post-anesthesia care unit.
Time frame: from extubation to the child is sent back to the ward, an average of 40 minutes
the amount of postoperative rescue analgesia ( with a FLACC score of >4)
ibuprofen (5-10mg/kg) was intravenously administered as rescue analgesia.
Time frame: 2, 4, 6, 12, 24, 48 hours after operation
This study is completed, as verified in Apr 2026. You cannot join it, but the record below documents what was studied.
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Cystic Adenomatoid Malformation of Lung, Congenital