Second Affiliated Hospital of Xi 'an Jiaotong University
Xi’an, Shanxi, 710004, China
NCT Number: NCT06498583
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.
Looking for future studies?
Notify Me1 month–12 month
All sexes
Interventional
Not applicable
Xi’an, Shanxi, 710004, China
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.
Healthy volunteers accepted: No
Only the study team can determine whether someone qualifies for participation.
Inclusion criteria
Exclusion criteria
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.
Time frame: 2, 4, 6, 12, 24, 48 hours after operation
Time frame: 1, 2, 3, 4, 5, 6, 7 days after operation
The Pittsburgh Sleep Quality Index was used to evaluate the sleep quality of children 7 days after surgery.
Time frame: from extubation to the child is sent back to the ward, an average of 40 minutes
The Pediatric Anesthesia Emergence Delirium (PAED) was used to evaluate emergence agitation after extubation in post-anesthesia care unit.
Time frame: 2, 4, 6, 12, 24, 48 hours after operation
ibuprofen (5-10mg/kg) was intravenously administered as rescue analgesia.
Lei Xiaoming
Other
OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.
View the official ClinicalTrials.gov record (opens in a new tab)This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.
Published trials that share one or more normalized conditions with this study.
NCT06302985
Bronchopulmonary Sequestration, Children
Wuhan, Hubei, China
View Trial DetailsNCT01732185
Congenital Abnormalities, Congenital Cystic Adenomatoid Malformation (CCAM)
Paris, France
View Trial DetailsNCT05752019
Bacterial Infections, Bacterial Infections and Mycoses
Rotterdam, South Holland, Netherlands
View Trial DetailsNCT00286143
Congenital Abnormalities, Congenital Cystic Adenomatoid Malformation
Philadelphia, Pennsylvania, United States
View Trial Details