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

Study Overview
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Brief Summary
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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.

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

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

Intervention / Treatment
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* Procedure: muscle layer fixation of thoracic drainage tube


Participation Criteria
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Eligibility Criteria
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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.

Ages Eligible for Study
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Minimum Age: 18 Years
Maximum Age: 80 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Treatment
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: None (Open Label)


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: muscle layer fixation group<br> | Procedure: muscle layer fixation of thoracic drainage tube<br>* The thoracic drainage tube is fixed on the muscle layer of the uniport<br>|
| No Intervention: conventional skin fixation group<br> | |

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| 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 | 
| Pain-associated inflammatory factor | the level of pain-associated inflammatory factor in blood, including CRP, PCT, IL6 and TNFa | the first day after surgery | 
| Dosage of analgesics | Dosage of analgesics | From date of operation until the date of chest tube removal, assessed up to 7 days | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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chest tube drainage, thoracic drainage, thoracoscopic surgery, Postoperative Pain