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

Not Applicable

• Conditions: Postoperative Pain; Pulmonary Neoplasm; Lung Neoplasms; Lung Cancer; Thoracoscopic Surgery
• Interventions: Procedure: muscle layer fixation of thoracic drainage tube

• Registration Number: NCT05202249
• Lead Sponsor: Daping Hospital and the Research Institute of Surgery of the Third Military Medical University

Brief 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.

Detailed Description

Not available

Study Timeline

• Study Start: 2021-11-15
• Status Verified: 2022-01
• Study First Submitted: 2022-01-09
• Study First Submitted QC: 2022-01-09
• Study First Posted: 2022-01-21
• Last Update Submitted: 2022-01-22
• Last Update Posted: 2022-02-04
• Primary Completion: 2022-03-15
• Study Completion: 2022-05-15

Recruitment & Eligibility

• Status: UNKNOWN
• Sex: All
• Target Recruitment: 60

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

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
muscle layer fixation group	muscle layer fixation of thoracic drainage tube	-

Primary Outcome Measures

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

Trial Locations

Locations (1)

Daping Hospital and the Research Institute of Surgery of the Third Military Medical University; 🇨🇳 Chongqing, Chongqing, China