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

NCT06498583 | Completed

• 1 other identifier: 2024-015
• Study Type: interventional
• Target: 68
• Locations: 1 country
• Sites: 1

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.

Conditions

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

Outcome Measures

Primary Outcomes (1)

• postoperative FLACC score

  2, 4, 6, 12, 24, 48 hours after operation

Secondary Outcomes (3)

• Postoperative sleep quality score

  1, 2, 3, 4, 5, 6, 7 days after operation

• Number of participants with emergence agitation as assessed by PAED

  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)

  2, 4, 6, 12, 24, 48 hours after operation

Study Arms (2)

E group

EXPERIMENTAL

Drug: Ropivacaine; Procedure: erector spinae plane block

P group

EXPERIMENTAL

Drug: Ropivacaine; Procedure: Incision infiltration of local anesthesia

Interventions

Ropivacaine DRUG

0.25 % ropivacaine ( 0.5ml / kg )

E group; P group

erector spinae plane block PROCEDURE

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

E group

Incision infiltration of local anesthesia PROCEDURE

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

P group

Eligibility Criteria

• Age: 1 Month - 12 Months
• Sex: all
• Healthy Volunteers: No
• Age Groups: Child (0-17)

You may qualify if:

• 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)

You may not qualify if:

• 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

Sponsors & Collaborators

• Lei Xiaoming: lead

Study Sites (1)

Second Affiliated Hospital of Xi 'an Jiaotong University

Xi’an, Shanxi, 710004, China

Location

MeSH Terms

Conditions

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

Interventions

Ropivacaine

Condition Hierarchy (Ancestors)

Lung Diseases; Respiratory Tract Diseases; Respiratory System Abnormalities; Congenital Abnormalities; Congenital, Hereditary, and Neonatal Diseases and Abnormalities; Cysts; Neoplasms; Bronchial Diseases

Intervention Hierarchy (Ancestors)

Anilides; Amides; Organic Chemicals; Aniline Compounds; Amines

Study Officials

• Xiaoming Lei, chief physician

  Second Affiliated Hospital of Xi 'an Jiaotong University

  STUDY CHAIR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: TRIPLE
• Who Masked: PARTICIPANT, CARE PROVIDER, INVESTIGATOR
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: SPONSOR INVESTIGATOR
• PI Title: chief physician

Study Record Dates

• First Submitted: June 28, 2024
• First Posted: July 12, 2024
• Study Start: January 9, 2024
• Primary Completion: February 28, 2025
• Study Completion: March 3, 2025
• Last Updated: April 22, 2026

Record last verified: 2026-04

Locations

CN (1)