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

Last Updated: 2024-09-19

Basic Information

• Recruitment Status: RECRUITING
• Clinical Phase: NA
• Total Enrollment: 40 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2024-09-05
• Study Completion Date: 2025-02-28

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.

Conditions

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

Study Design

• Allocation Method: RANDOMIZED
• Intervention Model: PARALLEL
• Primary Study Purpose: TREATMENT
• Blinding Strategy: TRIPLE

Study Groups

E group

Group Type: EXPERIMENTAL

Ropivacaine

Intervention Type: DRUG

0.25 % ropivacaine ( 0.5ml / kg )

erector spinae plane block

Intervention Type: PROCEDURE

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

P group

Group Type: EXPERIMENTAL

Ropivacaine

Intervention Type: DRUG

0.25 % ropivacaine ( 0.5ml / kg )

Incision infiltration of local anesthesia

Intervention Type: PROCEDURE

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

Interventions

Ropivacaine

0.25 % ropivacaine ( 0.5ml / kg )

Intervention Type: DRUG

erector spinae plane block

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

Intervention Type: PROCEDURE

Incision infiltration of local anesthesia

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

Intervention Type: PROCEDURE

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

• Minimum Eligible Age: 1 Month
• Maximum Eligible Age: 12 Months
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

Lei Xiaoming

OTHER

Sponsor Role: lead

Responsible Party

Lei Xiaoming

chief physician

Responsibility Role: SPONSOR_INVESTIGATOR

Principal Investigators

Xiaoming Lei, chief physician

Role: STUDY_CHAIR

Second Affiliated Hospital of Xi 'an Jiaotong University

Locations

Second Affiliated Hospital of Xi 'an Jiaotong University

Xi’an, Shanxi, China

Site Status: RECRUITING

Countries

China

Central Contacts

Xiaoming Lei, chief physician

Role: CONTACT

leixiaoming007@163.com

+8613571903125

Facility Contacts

Xiaoming Lei, chief physician

Role: primary

leixiaoming007@163.com

0086-13571903125

Other Identifiers

2024-015

Identifier Type: -

Identifier Source: org_study_id