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Effect of Ultrasound-guided Erector Spinae Plane Block on Postoperative Pain and Sleep Quality of Infants With Congenital Pulmonary Cystic Disease After Thoracoscopic Surgery

Effect of Ultrasound-guided Erector Spinae Plane Block on Postoperative Pain and Sleep Quality of Infants With Congenital Pulmonary Cystic Disease After Thoracoscopic Surgery

Status
Completed
Phases
Unknown
Study type
Interventional
Source
ClinicalTrials.gov
Registry ID
NCT06498583
Enrollment
68
Registered
2024-07-12
Start date
2024-01-09
Completion date
2025-03-03
Last updated
2026-04-22

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Bronchogenic Cyst, Bronchopulmonary Sequestration, Cystic Adenomatoid Malformation of Lung, Congenital

Brief summary

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.

Detailed description

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.

Interventions

DRUGRopivacaine

0.25 % ropivacaine ( 0.5ml / kg )

PROCEDUREerector spinae plane block

After the operation, unilateral erector spinae plane block was performed at the T5 level under ultrasound guidance.

PROCEDUREIncision infiltration of local anesthesia

After the operation, Incision infiltration of local anesthesia is performed around the surgical incisions.

Sponsors

Lei Xiaoming
Lead SponsorOTHER

Study design

Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT
Masking
TRIPLE (Subject, Caregiver, Investigator)

Eligibility

Sex/Gender
ALL
Age
1 Months to 12 Months
Healthy volunteers
No

Inclusion criteria

* American Society of Anesthesiologists (ASA) status I-II * age 1 month - 12 mouths old * preoperative diagnosis was congenital cystic lung disease * thoracoscopic lung lesion resection(lung lobectomy or segmentectomy)

Exclusion criteria

* patient with a history of allergy to amide local anesthetics * family members refused to participate in the study. * combined congenital heart disease * patient with skin damage or infection at the proposed puncture site * patients with scoliosis

Design outcomes

Primary

MeasureTime frame
postoperative FLACC score2, 4, 6, 12, 24, 48 hours after operation

Secondary

MeasureTime frameDescription
Postoperative sleep quality score1, 2, 3, 4, 5, 6, 7 days after operationThe Pittsburgh Sleep Quality Index was used to evaluate the sleep quality of children 7 days after surgery.
Number of participants with emergence agitation as assessed by PAEDfrom extubation to the child is sent back to the ward, an average of 40 minutesThe Pediatric Anesthesia Emergence Delirium (PAED) was used to evaluate emergence agitation after extubation in post-anesthesia care unit.
the amount of postoperative rescue analgesia ( with a FLACC score of >4)2, 4, 6, 12, 24, 48 hours after operationibuprofen (5-10mg/kg) was intravenously administered as rescue analgesia.

Countries

China

Contacts

STUDY_CHAIRXiaoming Lei, chief physician

Second Affiliated Hospital of Xi 'an Jiaotong University

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Apr 23, 2026