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

NCT ID: NCT05202249

Last Updated: 2022-02-04

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

UNKNOWN

Clinical Phase

NA

Total Enrollment

60 participants

Study Classification

INTERVENTIONAL

Study Start Date

2021-11-15

Study Completion Date

2022-05-15

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.

Detailed Description

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Conditions

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Lung Neoplasms Lung Cancer Pulmonary Neoplasm Postoperative Pain Thoracoscopic Surgery

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

Primary Study Purpose

TREATMENT

Blinding Strategy

NONE

Study Groups

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muscle layer fixation group

Group Type EXPERIMENTAL

muscle layer fixation of thoracic drainage tube

Intervention Type PROCEDURE

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

conventional skin fixation group

Group Type NO_INTERVENTION

No interventions assigned to this group

Interventions

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muscle layer fixation of thoracic drainage tube

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

Intervention Type PROCEDURE

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.
Minimum Eligible Age

18 Years

Maximum Eligible Age

80 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No

Sponsors

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

OTHER

Sponsor Role lead

Responsible Party

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Kun Li, MD

Kun Li, MD

Responsibility Role PRINCIPAL_INVESTIGATOR

Locations

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

Chongqing, Chongqing Municipality, China

Site Status RECRUITING

Countries

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China

Facility Contacts

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Kun Li, MD

Role: primary

+8615023072303 ext. 023-68757983

Kejie Huang, Bachelor

Role: backup

+8615123978947 ext. 023-68757982

Other Identifiers

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Kli4

Identifier Type: -

Identifier Source: org_study_id

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