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

January 22, 2022 updated by: Kun Li, MD, Daping Hospital and the Research Institute of Surgery of the Third Military Medical University

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

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.

Study Overview

Status

Recruiting

Conditions

Intervention / Treatment

Study Type

Interventional

Enrollment (Anticipated)

60

Phase

  • Not Applicable

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • China
    • Chongqing
      • Chongqing, Chongqing, China, 400042
        • Recruiting
        • Daping Hospital and the Research Institute of Surgery of the Third Military Medical University
        • Contact:

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

18 years to 80 years (Adult, Older Adult)

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Description

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 Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

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

Arms and Interventions

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

What is the study measuring?

Primary Outcome Measures

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

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

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

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

November 15, 2021

Primary Completion (Anticipated)

March 15, 2022

Study Completion (Anticipated)

May 15, 2022

Study Registration Dates

First Submitted

January 9, 2022

First Submitted That Met QC Criteria

January 9, 2022

First Posted (Actual)

January 21, 2022

Study Record Updates

Last Update Posted (Actual)

February 4, 2022

Last Update Submitted That Met QC Criteria

January 22, 2022

Last Verified

January 1, 2022

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • Kli4

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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