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Trial Title:
Effect of Ultrasound-guided Erector Spinae Plane Block on Postoperative Pain and Sleep Quality of Infants With Congenital Pulmonary Cystic Disease After Thoracoscopic Surgery
NCT ID:
NCT06498583
Condition:
Cystic Adenomatoid Malformation of Lung, Congenital
Bronchopulmonary Sequestration
Bronchogenic Cyst
Conditions: Official terms:
Bronchogenic Cyst
Bronchopulmonary Sequestration
Cystic Adenomatoid Malformation of Lung, Congenital
Pain, Postoperative
Ropivacaine
Study type:
Interventional
Study phase:
N/A
Overall status:
Recruiting
Study design:
Allocation:
Randomized
Intervention model:
Parallel Assignment
Primary purpose:
Treatment
Masking:
Triple (Participant, Care Provider, Investigator)
Intervention:
Intervention type:
Drug
Intervention name:
Ropivacaine
Description:
0.25 % ropivacaine ( 0.5ml / kg )
Arm group label:
E group
Arm group label:
P group
Intervention type:
Procedure
Intervention name:
erector spinae plane block
Description:
After the operation, unilateral erector spinae plane block was performed at the T5 level
under ultrasound guidance.
Arm group label:
E group
Intervention type:
Procedure
Intervention name:
Incision infiltration of local anesthesia
Description:
After the operation, Incision infiltration of local anesthesia is performed around the
surgical incisions.
Arm group label:
P group
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.
Criteria for eligibility:
Criteria:
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
Gender:
All
Minimum age:
1 Month
Maximum age:
12 Months
Healthy volunteers:
No
Locations:
Facility:
Name:
Second Affiliated Hospital of Xi 'an Jiaotong University
Address:
City:
Xi'an
Zip:
710004
Country:
China
Status:
Recruiting
Contact:
Last name:
Xiaoming Lei, chief physician
Phone:
0086-13571903125
Email:
leixiaoming007@163.com
Start date:
September 5, 2024
Completion date:
February 2025
Lead sponsor:
Agency:
Lei Xiaoming
Agency class:
Other
Source:
Xibei Hospital
Record processing date:
ClinicalTrials.gov processed this data on November 12, 2024
Source: ClinicalTrials.gov page:
https://clinicaltrials.gov/ct2/show/NCT06498583
