Effect of Muscle and Skin Fixation of Thoracic Drainage Tube on Postoperative Pain

Lung Cancer Clinical Trial

Official title:

Effect of Muscle and Skin Fixation of Thoracic Drainage Tube on Postoperative Pain in Patients Undergoing Uniport Thoracoscopic Pulmonary Resection

Clinical Trial Details — Status: Recruiting

Administrative data

• NCT number: NCT05202249
• Other study ID #: Kli4
• Status: Recruiting
• Phase: N/A
• 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
• 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.

Related Conditions & MeSH terms

• Lung Cancer
• Lung Neoplasms
• Neoplasms
• Pain, Postoperative
• Postoperative Pain
• Pulmonary Neoplasm
• Thoracoscopic Surgery

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