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

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.

Study Overview

• Status: Completed
• Conditions: Cystic Adenomatoid Malformation of Lung, Congenital; Bronchopulmonary Sequestration; Bronchogenic Cyst
• Intervention / Treatment: Drug: Ropivacaine; Procedure: erector spinae plane block; Procedure: Incision infiltration of local anesthesia

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 Type: Interventional
• Enrollment (Actual): 68
• Phase: Not Applicable

Contacts and Locations

Study Locations

• China
  • Shanxi
    • Xi’an, Shanxi, China, 710004
      • Second Affiliated Hospital of Xi 'an Jiaotong University

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: Child
• Accepts Healthy Volunteers: No

Description

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

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Treatment
• Allocation: Randomized
• Interventional Model: Parallel Assignment
• Masking: Triple

Number of Arms

2

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Experimental: E group	Drug: Ropivacaine; 0.25 % ropivacaine ( 0.5ml / kg ); Procedure: erector spinae plane block; After the operation, unilateral erector spinae plane block was performed at the T5 level under ultrasound guidance.
Experimental: P group	Drug: Ropivacaine; 0.25 % ropivacaine ( 0.5ml / kg ); Procedure: Incision infiltration of local anesthesia; After the operation, Incision infiltration of local anesthesia is performed around the surgical incisions.

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Time Frame
postoperative FLACC score	2, 4, 6, 12, 24, 48 hours after operation

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Postoperative sleep quality score	The Pittsburgh Sleep Quality Index was used to evaluate the sleep quality of children 7 days after surgery.	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.	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.	2, 4, 6, 12, 24, 48 hours after operation

Collaborators and Investigators

• Sponsor: Lei Xiaoming
• Investigators: Study Chair: Xiaoming Lei, chief physician, Second Affiliated Hospital of Xi 'an Jiaotong University

Study record dates

Study Major Dates

• Study Start (Actual): January 9, 2024
• Primary Completion (Actual): February 28, 2025
• Study Completion (Actual): March 3, 2025

Study Registration Dates

• First Submitted: June 28, 2024
• First Submitted That Met QC Criteria: July 6, 2024
• First Posted (Actual): July 12, 2024

Study Record Updates

• Last Update Posted (Actual): April 22, 2026
• Last Update Submitted That Met QC Criteria: April 21, 2026
• Last Verified: April 1, 2026

More Information

Terms related to this study

• Additional Relevant MeSH Terms: Neoplasms; Respiratory Tract Diseases; Lung Diseases; Bronchial Diseases; Congenital Abnormalities; Cysts; Respiratory System Abnormalities; Congenital, Hereditary, and Neonatal Diseases and Abnormalities; Cystic Adenomatoid Malformation of Lung, Congenital; Bronchopulmonary Sequestration; Bronchogenic Cyst; Organic Chemicals; Anilides; Amides; Aniline Compounds; Amines; Ropivacaine
• Other Study ID Numbers: 2024-015

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No