pMDT in Thoracic Surgery--------For the Baseline Investigation and Technical Preparation Stage

March 27, 2022 updated by: Yi Feng, MD, Peking University People's Hospital

Perioperative Pain Management With Multi-discipline Team(pMDT) in Thoracic Surgery: a Multi-center，Prospective, Observational Study--------For the Baseline Investigation and Technical Preparation Stage

The risk of acute and chronic pain after thoracic surgery is high. The multi-disciplinary postoperative pain management strategy is the best way to control postoperative pain in thoracic surgery. Through nearly one year of experience in implementation of the pMDT in the thoracic surgery department of Peking University People's Hospital, the investigators have summarized the experience in multidisciplinary pain management and promoted this study in multi-centers across the country, hoping that this study can improve the current situation of acute pain management in patients after thoracic surgery, and at the same time, the deficiencies of this clinical protocol can be found out and improved.

Study Overview

Status

Status

Indicates the current recruitment status or the expanded access status.
Completed

Conditions

Conditions

The disease, disorder, syndrome, illness, or injury that is being studied. On ClinicalTrials.gov, conditions may also include other health-related issues, such as lifespan, quality of life, and health risks.

Intervention / Treatment

Intervention / Treatment

A process or action that is the focus of a clinical study. Interventions include drugs, medical devices, procedures, vaccines, and other products that are either investigational or already available. Interventions can also include noninvasive approaches, such as education or modifying diet and exercise.

Detailed Description

The postoperative acute pain refers to the acute pain (usually lasting less than 7 days) that occurs immediately after surgery, and its nature is traumatic pain. It may develop into a chronic pain, such as a neuropathic pain or a mixed pain, if it is not fully controlled at the initial state. It will seriously impact the physiology and psychology of a patient. According to the study, the postoperative acute pain is one of the risks for postoperative complications, and it may result in the death of a patient. However, the alleviation of a postoperative acute pain can shorten the duration of stay in hospital, and reduce the overall cost for treatment of a patient.

The risk of acute and chronic pain after thoracic surgery is high. The multi-disciplinary postoperative pain management strategy is the best way to control postoperative pain in thoracic surgery. Through nearly one year of experience in implementation of the pMDT in the thoracic surgery department of Peking University People's Hospital, the investigators have summarized the experience in multidisciplinary pain management and promoted this study in multi-centers across the country, hoping that this study can improve the current situation of acute pain management in patients after thoracic surgery, and at the same time, the deficiencies of this clinical protocol can be found out and improved.

Study Type

Study Type

Describes the nature of a clinical study. Study types include interventional studies (also called clinical trials), observational studies (including patient registries), and expanded access.
Observational

Enrollment (Actual)

Enrollment

The number of participants in a clinical study. The "anticipated" enrollment is the target number of participants that the researchers need for the study.
480

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
    • Beijing
      • Beijing, Beijing, China, 100044
        • Peking University People's Hospital

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

Eligibility Criteria

The key requirements that people who want to participate in a clinical study must meet or the characteristics they must have. Eligibility criteria consist of both inclusion criteria (which are required for a person to participate in the study) and exclusion criteria (which prevent a person from participating). Types of eligibility criteria include whether a study accepts healthy volunteers, has age or age group requirements, or is limited by sex.

Ages Eligible for Study

18 years to 75 years (ADULT, OLDER_ADULT)

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Sampling Method

Probability Sample

Study Population

Patients undergoing thoracic surgery in Peking University People's Hospital and other multi-centers.

Description

Inclusion Criteria:

  • Patients aged between 18 and 75, ASA I-II;
  • Patients undergoing thoracoscopic surgery;
  • Patients who can understand and fill in the self-evaluation;
  • Patients who signed the Informed Consent Form.

Exclusion Criteria:

  • Pregnant women;
  • Patients with preoperative chronic pain and long-term opioid use;
  • Patients with advanced tumors who have received preoperative chemotherapy or who are expected to receive postoperative chemotherapy.

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

Cohorts and Interventions

Group / Cohort

Group / Cohort

A group or subgroup of participants in an observational study that is assessed for biomedical or health outcomes.
Intervention / Treatment

Intervention / Treatment

A process or action that is the focus of a clinical study. Interventions include drugs, medical devices, procedures, vaccines, and other products that are either investigational or already available. Interventions can also include noninvasive approaches, such as education or modifying diet and exercise.
Stage 1
For the Baseline Investigation and Technical Preparation Stage
Other: pMDT(Baseline Investigation)
The pMDT(Baseline Investigation) takes multi-model analgesia as the main technical means. Multimodal perioperative analgesia refers to the combination of analgesics, adjuvant drugs and analgesic techniques with different effects throughout the perioperative period to achieve the best curative effect of reducing postoperative acute and chronic pain.

What is the study measuring?

Primary Outcome Measures

Primary Outcome Measures

In a clinical study's protocol, the planned outcome measure that is the most important for evaluating the effect of an intervention/treatment. Most clinical studies have one primary outcome measure, but some have more than one.
Outcome Measure
Measure Description
Time Frame
The degree of patients' satisfaction
Time Frame: 3 days after surgery.
The degree of patients' satisfaction on pain managements. Patients were asked to give a score from 0-10 (0 means dissatisfied, 10 means very satisfied).
3 days after surgery.
Incidence rate of postoperative pain
Time Frame: Up to 90 days after surgery.
The percentage of patients with NRS score greater than 3
Up to 90 days after surgery.

Secondary Outcome Measures

Secondary Outcome Measures

In a clinical study's protocol, a planned outcome measure that is not as important as the primary outcome measure for evaluating the effect of an intervention but is still of interest. Most clinical studies have more than one secondary outcome measure.
Outcome Measure
Measure Description
Time Frame
Postoperative duration of stay in hospital
Time Frame: Up to 90 days after surgery.
The duration when patients stay in hospital after surgery.
Up to 90 days after surgery.
Rehospitalization rate
Time Frame: Up to 90 days after surgery.
The percentage of patients who are rehospitalized.
Up to 90 days after surgery.
Postoperative complication incidence rate
Time Frame: Up to 90 days after surgery.
The percentage of patients with complications after surgery.
Up to 90 days after surgery.

Collaborators and Investigators

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

Sponsor

Sponsor

The organization or person who initiates the study and who has authority and control over the study.
Peking University People's Hospital

Collaborators

Collaborators

An organization other than the sponsor that provides support for a clinical study. This support may include activities related to funding, design, implementation, data analysis, or reporting.
General Hospital of Shenyang Military Region
LanZhou University
Peking Union Medical College Hospital
Southwest Hospital, China
The First Affiliated Hospital of Zhengzhou University
Guangdong Provincial People's Hospital
Shanghai Chest Hospital
Henan Provincial People's Hospital
Qianfoshan Hospital
Hebei Medical University Fourth Hospital
Renmin Hospital of Wuhan University
Zhejiang University
The First Affiliated Hospital of Kunming Medical College
First Affiliated Hospital of Xinjiang Medical University
Second Affiliated Hospital of Nanchang University
Liaoning Tumor Hospital & Institute
First Affiliated Hospital of Chongqing Medical University
Fujian Provincial Hospital
Anhui Provincial Hospital
Second Hospital of Lanzhou University
Hebei Tumor Hospital
The People's Hospital of Gaozhou
Shanxi Provincial People's Hospital
Kunming General Hospital of PLA

Investigators

Investigators

A researcher involved in a clinical study. Related terms include site principal investigator, site sub-investigator, study chair, study director, and study principal investigator.
  • Study Director: Feng Yi, Peking University People's Hospital

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

General Publications

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)

Study Start

The actual date on which the first participant was enrolled in a clinical study. The "anticipated" study start date is the date that the researchers think will be the study start date.
September 1, 2018

Primary Completion (ACTUAL)

Primary Completion

The date on which the last participant in a clinical study was examined or received an intervention to collect final data for the primary outcome measure. Whether the clinical study ended according to the protocol or was terminated does not affect this date. For clinical studies with more than one primary outcome measure with different completion dates, this term refers to the date on which data collection is completed for all the primary outcome measures. The "anticipated" primary completion date is the date that the researchers think will be the primary completion date for the study.
August 31, 2019

Study Completion (ACTUAL)

Study Completion

The date on which the last participant in a clinical study was examined or received an intervention/treatment to collect final data for the primary outcome measures, secondary outcome measures, and adverse events (that is, the last participant's last visit). The "anticipated" study completion date is the date that the researchers think will be the study completion date.
August 31, 2021

Study Registration Dates

First Submitted

First Submitted

The date on which the study sponsor or investigator first submitted a study record to ClinicalTrials.gov. There is typically a delay of a few days between the first submitted date and the record's availability on ClinicalTrials.gov (the first posted date).
October 30, 2018

First Submitted That Met QC Criteria

First Submitted That Met QC Criteria

The date on which the study sponsor or investigator first submits a study record that is consistent with National Library of Medicine (NLM) quality control (QC) review criteria. The sponsor or investigator may need to revise and submit a study record one or more times before NLM's QC review criteria are met. It is the responsibility of the sponsor or investigator to ensure that the study record is consistent with the NLM QC review criteria.
November 28, 2018

First Posted (ACTUAL)

First Posted

The date on which the study record was first available on ClinicalTrials.gov after National Library of Medicine (NLM) quality control (QC) review has concluded. There is typically a delay of a few days between the date the study sponsor or investigator submitted the study record and the first posted date.
November 29, 2018

Study Record Updates

Last Update Posted (ACTUAL)

Last Update Posted

The most recent date on which changes to a study record were made available on ClinicalTrials.gov. There may be a delay between when the changes were submitted to ClinicalTrials.gov by the study's sponsor or investigator (the last update submitted date) and the last update posted date.
March 29, 2022

Last Update Submitted That Met QC Criteria

Last Update Submitted That Met QC Criteria

The most recent date on which the study sponsor or investigator submitted changes to a study record that are consistent with National Library of Medicine (NLM) quality control (QC) review criteria. It is the responsibility of the sponsor or investigator to ensure that the study record is consistent with the NLM QC review criteria.
March 27, 2022

Last Verified

Last Verified

The most recent date on which the study sponsor or investigator confirmed the information about a clinical study on ClinicalTrials.gov as accurate and current. If a study with a recruitment status of recruiting; not yet recruiting; or active, not recruiting has not been confirmed within the past 2 years, the study's recruitment status is shown as unknown.
March 1, 2022

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

Other Study ID Numbers

Identifiers or ID numbers other than the NCT number that are assigned to a clinical study by the study's sponsor, funders, or others. These numbers may include unique identifiers from other trial registries and National Institutes of Health grant numbers.
  • 2018PHB053-01

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

NO

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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