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Clinical Trial Details — Status: Recruiting

Administrative data

NCT number NCT05202249
Other study ID # Kli4
Secondary ID
Status Recruiting
Phase N/A
First received
Last updated
Start date November 15, 2021
Est. completion date May 15, 2022

Study information

Verified date January 2022
Source Daping Hospital and the Research Institute of Surgery of the Third Military Medical University
Contact n/a
Is FDA regulated No
Health authority
Study type Interventional

Clinical Trial Summary

Lung cancer is the leading cause of cancer-related death worldwide. Thoracoscopic pulmonary resection is a prevalent management for early stage of lung cancer. Placement of chest tube is the standard procedure after surgery, which causes pain that cannot be ignored. The investigators aimed to determine whether a muscle layer fixation of thoracic drainage tube could release postoperative pain in patients with uniport thoracoscopic pulmonary resection compared with conventional skin fixation.


Recruitment information / eligibility

Status Recruiting
Enrollment 60
Est. completion date May 15, 2022
Est. primary completion date March 15, 2022
Accepts healthy volunteers No
Gender All
Age group 18 Years to 80 Years
Eligibility Inclusion Criteria: - 18<age<80; - ASA=III - Patients with no clinically significant cardiac history, such as ischaemic heart disease, valvular heart disease, rhythm disturbances such as frequent atrial fibrillation or premature ventricular contractions (PVCs). Patients with significant cardiac history should be optimized according the relevant guidelines before surgery is considered. - Normal cardiopulmonary function [predicted forced expiratory volume in the first second(FEV1%) >50% and ejection fraction (EF) >50%of predicted value]. Resting blood gas analysis showing arterial partial pressure of oxygen (PaO2)=75 mmHg and arterial partial pressure of carbon dioxide (PaCO2) <45 mmHg; Exclusion Criteria: - History of ipsilateral surgery and other conditions which can result in extensive pleural adhesion; - Coagulopathy, hypoxemia (PaO2 <60 mmHg), hypercapnia [arterial carbon dioxide tension(PaCO2) >50 mmHg]; - Significant cardiac history.

Study Design


Intervention

Procedure:
muscle layer fixation of thoracic drainage tube
The thoracic drainage tube is fixed on the muscle layer of the uniport

Locations

Country Name City State
China Daping Hospital and the Research Institute of Surgery of the Third Military Medical University Chongqing Chongqing

Sponsors (1)

Lead Sponsor Collaborator
Daping Hospital and the Research Institute of Surgery of the Third Military Medical University

Country where clinical trial is conducted

China, 

Outcome

Type Measure Description Time frame Safety issue
Primary Postoperative Pain The postoperative pain is assessed using a Visual Analog Scale (VAS) From date of operation until the date of chest tube removal, assessed up to 7 days
Primary Pain-associated inflammatory factor the level of pain-associated inflammatory factor in blood, including CRP, PCT, IL6 and TNFa the first day after surgery
Primary Dosage of analgesics Dosage of analgesics From date of operation until the date of chest tube removal, assessed up to 7 days
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