Cystic Adenomatoid Malformation of Lung, CongenitalNCT06498583
Effect of Ultrasound-guided Erector Spinae Plane Block on Postoperative Pain and Sleep Quality of Infants With Congenital Pulmonary Cystic Disease After Thoracoscopic Surgery
A study testing Ropivacaine, erector spinae plane block and Incision infiltration of local anesthesia in people with Cystic Adenomatoid Malformation of Lung, Congenital and Bronchopulmonary Sequestration, run by Lei Xiaoming at 1 site in China.
Trial 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. Read more about this study
- Who is it for?
- Ages 1 month to 12 months
- Conditions the study is for
- Cystic Adenomatoid Malformation of Lung, Congenital, Bronchopulmonary Sequestration, Bronchogenic Cyst
- What is being tested?
- Ropivacaine, erector spinae plane block and Incision infiltration of local anesthesia
- Type of treatment
- Surgery or procedure
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 68 participants
- Where
- 1 siteChina
- Study dates
- 9 Jan 2024to 3 Mar 2025
- Phase
- Interventional
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 1 month to 12 months
- All sexes
- No healthy volunteers
- Child
Who may be able to join
- 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)
Who cannot join
- 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
Trial locations and contacts
1 site in 1 country.
China1 site
Second Affiliated Hospital of Xi 'an Jiaotong University
Xi’an, Shanxi, 710004
About this study
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.
Read the 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.
- Conditions
- Cystic Adenomatoid Malformation of Lung, Congenital, Bronchopulmonary Sequestration, Bronchogenic Cyst
- Being tested
- Ropivacaine, erector spinae plane block, Incision infiltration of local anesthesia
- Medical subject headings
- Cystic Adenomatoid Malformation of Lung, Congenital, Bronchopulmonary Sequestration, Bronchogenic Cyst
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
RopivacaineDrug
0.25 % ropivacaine ( 0.5ml / kg )
erector spinae plane blockProcedure or surgery
After the operation, unilateral erector spinae plane block was performed at the T5 level under ultrasound guidance.
Incision infiltration of local anesthesiaProcedure or surgery
After the operation, Incision infiltration of local anesthesia is performed around the surgical incisions.
| Study group | Role | What they receive |
|---|---|---|
| E group | Experimental | Not described Receives: Drug: Ropivacaine; Procedure: erector spinae plane block |
| P group | Experimental | Not described Receives: Drug: Ropivacaine; Procedure: Incision infiltration of local anesthesia |
What is being measured
The primary outcome is the main question the study is designed to answer.
postoperative FLACC score
Measured: 2, 4, 6, 12, 24, 48 hours after operation
Secondary outcomes (3)
Postoperative sleep quality score
The Pittsburgh Sleep Quality Index was used to evaluate the sleep quality of children 7 days after surgery.
Measured: 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.
Measured: 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.
Measured: 2, 4, 6, 12, 24, 48 hours after operation
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted12 Jul 2024
- Study start9 Jan 2024
- Primary completion28 Feb 2025
- Study completion3 Mar 2025
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Cystic Adenomatoid Malformation of Lung, CongenitalStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Triple blind
- Who is masked
- Participant, Care provider, Investigator
- Enrolment
- 68 participants (actual)
Sponsor and investigators
- Lead sponsor
- Lei Xiaoming
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor-investigator, Lei Xiaoming, Xibei Hospital
- Investigators
- Xiaoming Lei, chief physician, Study chair, Second Affiliated Hospital of Xi 'an Jiaotong University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06498583
- Sponsor's protocol ID
- 2024-015
- Status last verified
- Apr 2026
- First submitted
- 28 Jun 2024
- Last updated
- 22 Apr 2026
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
Study at a glance
From the registry record, last updated by the sponsor on 22 Apr 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official 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
- ClinicalTrials.gov ID
- NCT06498583
- Acronym / sponsor ID
- 2024-015
- Conditions
- Cystic Adenomatoid Malformation of Lung, Congenital, Bronchopulmonary Sequestration, Bronchogenic Cyst
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 68 participants (actual)
- Lead sponsor
- Lei XiaomingUniversity, hospital or other
- Study start
- 9 Jan 2024 (actual)
- Primary completion
- 28 Feb 2025 (actual)
- Study completion
- 3 Mar 2025 (actual)
- First posted
- 12 Jul 2024 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Triple blind (participant, care provider, investigator)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| E group | Experimental | Drug: Ropivacaine, Procedure: erector spinae plane block |
| P group | Experimental | Drug: Ropivacaine, Procedure: Incision infiltration of local anesthesia |
Who may qualify
- Ages
- 1 month to 12 months
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Child
Key inclusion criteria (4 listed)
- 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)
Key exclusion criteria (5 listed)
- 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
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Ropivacaine0.25 % ropivacaine ( 0.5ml / kg ) | Drug | E group, P group |
| erector spinae plane blockAfter the operation, unilateral erector spinae plane block was performed at the T5 level under ultrasound guidance. | Procedure or surgery | E group |
| Incision infiltration of local anesthesiaAfter the operation, Incision infiltration of local anesthesia is performed around the surgical incisions. | Procedure or surgery | P group |
Primary outcome
postoperative FLACC score
Time frame: 2, 4, 6, 12, 24, 48 hours after operation
3 secondary outcomes
Postoperative sleep quality score
Time frame: 1, 2, 3, 4, 5, 6, 7 days after operation
Number of participants with emergence agitation as assessed by PAED
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)
Time frame: 2, 4, 6, 12, 24, 48 hours after operation
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 22 Apr 2026.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Xiaoming Lei, chief physician study chair
Second Affiliated Hospital of Xi 'an Jiaotong University
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Ropivacaine, erector spinae plane block and Incision infiltration of local anesthesia in people with Cystic Adenomatoid Malformation of Lung, Congenital and Bronchopulmonary Sequestration, run by Lei Xiaoming at 1 site in China.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 4 inclusion and 5 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 22 Apr 2026. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in China. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
postoperative FLACC score (time frame: 2, 4, 6, 12, 24, 48 hours after operation). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 22 Apr 2026; AzTrials last refreshed its copy on 7 Nov 2026.