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

NCT05202249 | Unknown

• 1 other identifier: Kli4
• Study Type: interventional
• Target: 60
• Locations: 1 country
• Sites: 1

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.

Conditions

Lung Neoplasms; Lung Cancer; Pulmonary Neoplasm; Postoperative Pain; Thoracoscopic Surgery

Keywords

chest tube drainage; thoracic drainage; thoracoscopic surgery; Postoperative Pain

Outcome Measures

Primary Outcomes (3)

• 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

Study Arms (2)

muscle layer fixation group

EXPERIMENTAL

Procedure: muscle layer fixation of thoracic drainage tube

conventional skin fixation group

NO INTERVENTION

Interventions

muscle layer fixation of thoracic drainage tube PROCEDURE

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

muscle layer fixation group

Eligibility Criteria

• Age: 18 Years - 80 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• \<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;

You may not qualify if:

• 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.

Sponsors & Collaborators

• Daping Hospital and the Research Institute of Surgery of the Third Military Medical University: lead

Study Sites (1)

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

Chongqing, Chongqing Municipality, 400042, China

RECRUITING

MeSH Terms

Conditions

Lung Neoplasms; Pain, Postoperative

Condition Hierarchy (Ancestors)

Respiratory Tract Neoplasms; Thoracic Neoplasms; Neoplasms by Site; Neoplasms; Lung Diseases; Respiratory Tract Diseases; Postoperative Complications; Pathologic Processes; Pathological Conditions, Signs and Symptoms; Pain; Neurologic Manifestations; Signs and Symptoms

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Kun Li, MD

Study Record Dates

• First Submitted: January 9, 2022
• First Posted: January 21, 2022
• Study Start: November 15, 2021
• Primary Completion: March 15, 2022
• Study Completion: May 15, 2022
• Last Updated: February 4, 2022

Record last verified: 2022-01

Locations

CN (1)